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    Clinical Trial Results:
    An uncontrolled, open-label, titration, long-term safety (up to 12 months) and efficacy study of tamsulosin hydrochloride in children with neuropathic bladder, with a randomized pharmacokinetic sub-study investigating low, medium and high dose ranges.

    Due to a system error, the data reported in v1 is not correct and has been removed from public view.
    Summary
    EudraCT number
    2006-004423-11
    Trial protocol
    DE   IT   BE   ES  
    Global end of trial date
    30 Jun 2009

    Results information
    Results version number
    v2(current)
    This version publication date
    23 Jul 2016
    First version publication date
    01 Aug 2015
    Other versions
    v1 (removed from public view)
    Version creation reason
    • Correction of full data set
    Data correction due to a system error in EudraCT- Results

    Trial information

    Close Top of page
    Trial identification
    Sponsor protocol code
    527.66
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    NCT00340704
    WHO universal trial number (UTN)
    -
    Sponsors
    Sponsor organisation name
    Boehringer Ingelheim
    Sponsor organisation address
    Binger Strasse 173, Ingelheim am Rhein, Germany, 55216
    Public contact
    QRPE Processes and Systems Coordination Clinical Trial Information Disclosure, Boehringer Ingelheim, +1 8002430127, clintriage.rdg@boehringer-ingelheim.com
    Scientific contact
    QRPE Processes and Systems Coordination Clinical Trial Information Disclosure, Boehringer Ingelheim , +1 8002430127, clintriage.rdg@boehringer-ingelheim.com
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    Yes
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    23 Oct 2009
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    30 Jun 2009
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main objective of the trial
    To characterise the pharmacokinetic (PK)/ pharmacodynamic (PD) profile and evaluate the safety and efficacy of tamsulosin hydrochloride (HCL) in children with an elevated detrussor leak point pressure associated with a known neurological disorder (e.g. spinal bifida), after which long-term safety can be assessed. This trial has 3 different Data base locks (DBL) based on three separate populations PK / PD, Group D – Denovo and Group D – 527.51 Rollover. For PK / PD population the DBL date was 18July2007, for Group D – Denovo population the DBL date was 23Jan2009 and for Group D – 527.51 Rollover population the DBL date was 11Sep2009. The Group D-Rollover portion of Study 527.66 was terminated early based on data from placebo-controlled Study 527.51 that showed lack of efficacy, thus, caution should be used in interpreting these results due to the impact of the early termination, as well as the impact of the study design on interpretation of results by dose.
    Protection of trial subjects
    Only subjects that met all the study inclusion and none of the exclusion criteria were to be entered in the study. All subjects were free to withdraw from the clinical trial at any time for any reason given. Close monitoring of all subjects was adhered to throughout the trial conduct.
    Background therapy
    -
    Evidence for comparator
    -
    Actual start date of recruitment
    19 Apr 2006
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Spain: 5
    Country: Number of subjects enrolled
    Italy: 6
    Country: Number of subjects enrolled
    India: 26
    Country: Number of subjects enrolled
    United States: 58
    Country: Number of subjects enrolled
    Mexico: 53
    Country: Number of subjects enrolled
    Russian Federation: 5
    Country: Number of subjects enrolled
    Korea, Republic of: 18
    Country: Number of subjects enrolled
    South Africa: 14
    Country: Number of subjects enrolled
    Ukraine: 13
    Country: Number of subjects enrolled
    Philippines: 51
    Country: Number of subjects enrolled
    Brazil: 22
    Country: Number of subjects enrolled
    Canada: 5
    Country: Number of subjects enrolled
    Germany: 8
    Worldwide total number of subjects
    284
    EEA total number of subjects
    19
    Number of subjects enrolled per age group
    In utero
    0
    Preterm newborn - gestational age < 37 wk
    0
    Newborns (0-27 days)
    0
    Infants and toddlers (28 days-23 months)
    0
    Children (2-11 years)
    226
    Adolescents (12-17 years)
    58
    Adults (18-64 years)
    0
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

    Close Top of page
    Recruitment
    Recruitment details
    This trial has 3 different DBLs and 3 different Clinical trial reports which were prepared based on 3 separate populations PK/PD, Group D-Denovo and Group D-527.51 Rollover. Group D-Denovo includes subjects from PK Phase and additional subjects and Group D – 527.51 Rollover includes subjects who successfully completed tamsulosin HCl Study 527.51.

    Pre-assignment
    Screening details
    All subjects were screened for eligibility to participate in the trial. Subjects attended specialist sites which would then ensure that they (the subjects) met all strictly implemented inclusion/exclusion criteria. Subjects were not to be randomised to trial treatment if any one of the specific entry criteria were violated.

    Period 1
    Period 1 title
    PK sub-study (Treatment period)
    Is this the baseline period?
    No
    Allocation method
    Not applicable
    Blinding used
    Not blinded
    Blinding implementation details
    This was an open label, randomised and uncontrolled study.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    tamsulosin - low dose level (Steady State - PK study)
    Arm description
    Subjects randomized to low dose level (0.001–0.002 mg/kg) of tamsulosin hydrochloride, dependent on a subject's body weight. In PK study, all subjects were titrated to their randomized dose level that they needed to receive which was based on their weight. Depending on the results of the Leak point pressure (LPP) results, subjects could remain on that dose if it was found to be efficacious or go back to a lower efficacious dose or titrate up in hopes that the higher dose would provide some efficacy. Subjects with body weight of 12.1–25.0 kg received low dose of 0.025 mg qd (once daily), body weight of 25.1–50.0 kg received low dose of 0.05 mg qd and body weight of 50.1–100.0 kg received low dose of 0.1 mg qd by sprinkling the content of the capsule(s) over teaspoon of apple sauce or yogurt taken 30 minutes after breakfast.
    Arm type
    Experimental

    Investigational medicinal product name
    tamsulosin hydrochloride (0.025 mg)
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    Subjects randomized to low dose level (0.001–0.002 mg/kg) of tamsulosin hydrochloride and body weight of 12.1–25.0 kg received low dose of 0.025 mg qd by sprinkling the content of the capsule(s) over teaspoon of apple sauce or yogurt taken 30 minutes after breakfast.

    Investigational medicinal product name
    tamsulosin hydrochloride (0.05 mg)
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    Subjects randomized to low dose level (0.001–0.002 mg/kg) of tamsulosin hydrochloride and body weight of 25.1–50.0 kg received low dose of 0.05 mg qd by sprinkling the content of the capsule(s) over teaspoon of apple sauce or yogurt taken 30 minutes after breakfast.

    Investigational medicinal product name
    tamsulosin hydrochloride (0.1 mg)
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    Subjects randomized to low dose level (0.001–0.002 mg/kg) of tamsulosin hydrochloride and body weight of 50.1–100.0 kg received low dose of 0.1 mg qd by sprinkling the content of the capsule(s) over teaspoon of apple sauce or yogurt taken 30 minutes after breakfast.

    Arm title
    tamsulosin - medium dose level (Steady State - PK study)
    Arm description
    Subjects randomized to medium dose level (0.002–0.004 mg/kg) of tamsulosin hydrochloride, dependent on a subject's body weight. In PK study, all subjects were titrated to their randomized dose level that they needed to receive which was based on their weight. Depending on the results of the LPP results, subjects could remain on that dose if it was found to be efficacious or go back to a lower efficacious dose or titrate up in hopes that the higher dose would provide some efficacy. Subjects with body weight of 12.1–25.0 kg received medium dose of 0.05 mg qd, body weight of 25.1–50.0 kg received medium dose of 0.1 mg qd with and body weight of 50.1–100.0 kg received medium dose of 0.2 mg qd by sprinkling the content of the capsule(s) over teaspoon of apple sauce or yogurt, taken 30 minutes after breakfast.
    Arm type
    Experimental

    Investigational medicinal product name
    tamsulosin hydrochloride (0.05 mg)
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    Subjects randomized to medium dose level (0.002–0.004 mg/kg) of tamsulosin hydrochloride and body weight of 12.1–25.0 kg received medium dose of 0.05 mg qd by sprinkling the content of the capsule(s) over teaspoon of apple sauce or yogurt taken 30 minutes after breakfast.

    Investigational medicinal product name
    tamsulosin hydrochloride (0.1 mg)
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    Subjects randomized to medium dose level (0.002–0.004 mg/kg) of tamsulosin hydrochloride and body weight of 25.1–50.0 kg received medium dose of 0.1 mg qd by sprinkling the content of the capsule(s) over teaspoon of apple sauce or yogurt taken 30 minutes after breakfast.

    Investigational medicinal product name
    tamsulosin hydrochloride (0.2 mg)
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    Subjects randomized to medium dose level (0.002–0.004 mg/kg) of tamsulosin hydrochloride and body weight of 50.1–100.0 kg received medium dose of 0.2 mg qd by sprinkling the content of the capsule(s) over teaspoon of apple sauce or yogurt taken 30 minutes after breakfast.

    Arm title
    tamsulosin - high dose level (Steady State - PK study)
    Arm description
    Subjects randomized to high dose level(0.004-0.008mg/kg) of tamsulosin hydrochloride,dependent on a subject's body weight.In PK study,all subjects were titrated to their randomized dose level that they needed to receive which was based on their weight.Depending on the results of the LPP,subjects could remain on that dose if it was found to be efficacious or go back to a lower efficacious dose or titrate up in hopes that the higher dose would provide some efficacy. Subjects with body weight of 12.1-25.0kg received high dose of 0.1mg qd, body weight of 25.1-50.0kg received high dose of 0.2mg qd & body weight of 50.1-100.0kg received high dose of 0.4mg qd by sprinkling the content of the capsule(s) over teaspoon of apple sauce or yogurt taken 30 minutes after breakfast.One subject randomised to high dose level was not treated. Although actual number of subjects started is 11,10 were reported to ensure consistent reporting with baseline characteristics that includes only treated subjects.
    Arm type
    Experimental

    Investigational medicinal product name
    tamsulosin hydrochloride (0.1 mg)
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    Subjects randomized to high dose level (0.004-0.008mg/kg) of tamsulosin hydrochloride and body weight of 12.1-25.0 kg received high dose of 0.1 mg qd by sprinkling the content of the capsule(s) over teaspoon of apple sauce or yogurt taken 30 minutes after breakfast.

    Investigational medicinal product name
    tamsulosin hydrochloride (0.2 mg)
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    Subjects randomized to high dose level (0.004-0.008mg/kg) of tamsulosin hydrochloride and body weight of 25.1–50.0 kg received high dose of 0.2 mg qd by sprinkling the content of the capsule(s) over teaspoon of apple sauce or yogurt taken 30 minutes after breakfast.

    Investigational medicinal product name
    tamsulosin hydrochloride (0.4 mg)
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    Subjects randomized to high dose level (0.004-0.008mg/kg) of tamsulosin hydrochloride and body weight of 50.1–100.0 kg received high dose of 0.4 mg qd by sprinkling the content of the capsule(s) over teaspoon of apple sauce or yogurt taken 30 minutes after breakfast.

    Number of subjects in period 1
    tamsulosin - low dose level (Steady State - PK study) tamsulosin - medium dose level (Steady State - PK study) tamsulosin - high dose level (Steady State - PK study)
    Started
    10
    10
    10
    Completed
    10
    9
    10
    Not completed
    0
    1
    0
         Adverse event, non-fatal
    -
    1
    -
    Period 2
    Period 2 title
    Group D-Denovo (Treatment period)
    Is this the baseline period?
    No
    Allocation method
    Not applicable
    Blinding used
    Not blinded
    Blinding implementation details
    Open-label, uncontrolled trial and dose titrated, starting at the lowest dose level based on a subject's weight, in order to establish their individual efficacious dose.

    Arms
    Are arms mutually exclusive
    No

    Arm title
    tamsulosin - low dose level (Group D-Denovo)
    Arm description
    Subjects received low dose level (0.001 – 0.002 mg/kg) of tamsulosin hydrochloride, dependent on a subject's body weight. In Group D-Denovo, all subjects started the study at the low Dose level, with the exception of the children with a body weight between 9 kg and 12 kg (they started at the Medium Dose level), and titrated up to higher dose levels on a weekly basis until an efficacious level was reached. The subjects remained on their efficacious dose level for the remainder of the study. Subjects with body weight of 12.1– 25.0 kg received low dose of 0.025 mg qd, body weight of 25.1–50.0 kg received low dose of 0.05 mg qd and body weight of 50.1–100.0 kg received low dose of 0.1 mg qd by sprinkling the content of the capsule(s) over teaspoon of apple sauce or yogurt taken 30 minutes after breakfast.
    Arm type
    Experimental

    Investigational medicinal product name
    tamsulosin hydrochloride (0.025 mg)
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    Subjects with body weight of 12.1– 25.0 kg received low dose of 0.025 mg qd of tamsulosin hydrochloride by sprinkling the content of the capsule(s) over teaspoon of apple sauce or yogurt taken 30 minutes after breakfast.

    Investigational medicinal product name
    tamsulosin hydrochloride (0.05 mg)
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    Subjects with body weight of 25.1–50.0 kg received low dose of 0.05 mg qd of tamsulosin hydrochloride by sprinkling the content of the capsule(s) over teaspoon of apple sauce or yogurt taken 30 minutes after breakfast.

    Investigational medicinal product name
    tamsulosin hydrochloride (0.1 mg)
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    Subjects with body weight of 50.1–100.0 kg received low dose of 0.1 mg qd of tamsulosin hydrochloride by sprinkling the content of the capsule(s) over teaspoon of apple sauce or yogurt taken 30 minutes after breakfast.

    Arm title
    tamsulosin - medium dose level (Group D-Denovo)
    Arm description
    Subjects who were titrated to medium dose level (0.002–0.004 mg/kg) of tamsulosin hydrochloride, dependent on a subject's body weight. In Group D-Denovo, all subjects started the study at the Low Dose level, with the exception of the children with a body weight between 9 kg and 12 kg (they started at the Medium Dose level), and titrated up to higher dose levels on a weekly basis until an efficacious level was reached. The subjects remained on their efficacious dose level for the remainder of the study. Subjects with body weight of 9.0–12.0 kg received medium dose of 0.025 mg qd as their starting dose, body weight of 12.1-25.0 kg could have titrated to a medium dose of 0.05 mg qd, body weight of 25.1–50.0 kg could have titrated to a medium dose of 0.1 mg qd and body weight of 50.1–100.0 kg could have titrated to a medium dose of 0.2 mg qd by sprinkling the content of the capsule(s) over teaspoon of apple sauce or yogurt, taken 30 minutes after breakfast.
    Arm type
    Experimental

    Investigational medicinal product name
    tamsulosin hydrochloride (0.025 mg)
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    Subjects received medium dose level (0.002–0.004 mg/kg) of tamsulosin hydrochloride and body weight of 9.0–12.0 kg received medium dose of 0.025 mg qd by sprinkling the content of the capsule(s) over teaspoon of apple sauce or yogurt taken 30 minutes after breakfast.

    Investigational medicinal product name
    tamsulosin hydrochloride (0.05 mg)
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    Subjects who were titrated to medium dose level (0.002–0.004 mg/kg) of tamsulosin hydrochloride and body weight of 12.1–25.0 kg received medium dose of 0.05 mg qd by sprinkling the content of the capsule(s) over teaspoon of apple sauce or yogurt taken 30 minutes after breakfast.

    Investigational medicinal product name
    tamsulosin hydrochloride (0.1 mg)
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    Subjects who were titrated to medium dose level (0.002–0.004 mg/kg) of tamsulosin hydrochloride and body weight of 25.1–50.0 kg received medium dose of 0.1 mg qd by sprinkling the content of the capsule(s) over teaspoon of apple sauce or yogurt taken 30 minutes after breakfast.

    Investigational medicinal product name
    tamsulosin hydrochloride (0.2 mg)
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    Subjects who were titrated to medium dose level (0.002–0.004 mg/kg) of tamsulosin hydrochloride and body weight of 50.1–100.0 kg received medium dose of 0.2 mg qd by sprinkling the content of the capsule(s) over teaspoon of apple sauce or yogurt taken 30 minutes after breakfast.

    Arm title
    tamsulosin - high dose level (Group D-Denovo)
    Arm description
    Subjects titrated to high dose level (0.004-0.008 mg/kg) of tamsulosin hydrochloride, once daily dependent on a subject's body weight. In Group D-Denovo, all subjects started the study at the Low Dose level, with the exception of the children with a body weight between 9 kg and 12 kg (they started at the Medium Dose level), and titrated up to higher dose levels on a weekly basis until an efficacious level was reached. The subjects remained on their efficacious dose level for the remainder of the study. Subjects with body weight of 9.0-12.0 kg received high dose of 0.05 mg qd, body weight of 12.1-25.0 kg received high dose of 0.1 mg qd, body weight of 25.1-50.0 kg received high dose of 0.2 mg qd & body weight of 50.1-100.0 kg received high dose of 0.4 mg qd by sprinkling the content of the capsule(s) over teaspoon of apple sauce or yogurt, taken 30 minutes after breakfast.
    Arm type
    Experimental

    Investigational medicinal product name
    tamsulosin hydrochloride (0.05 mg)
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    Subjects who were titrated to high dose level (0.004-0.008 mg/kg) of tamsulosin hydrochloride and body weight of 9.0–12.0 kg received high dose of 0.05 mg qd by sprinkling the content of the capsule(s) over teaspoon of apple sauce or yogurt taken 30 minutes after breakfast.

    Investigational medicinal product name
    tamsulosin hydrochloride (0.1 mg)
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    Subjects who were titrated to high dose level (0.004-0.008 mg/kg) of tamsulosin hydrochloride and body weight of 12.1–25.0 kg received high dose of 0.1 mg qd by sprinkling the content of the capsule(s) over teaspoon of apple sauce or yogurt taken 30 minutes after breakfast.

    Investigational medicinal product name
    tamsulosin hydrochloride (0.2 mg)
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    Subjects who were titrated to high dose level (0.004-0.008 mg/kg) of tamsulosin hydrochloride and body weight of 25.1–50.0 kg received high dose of 0.2 mg qd by sprinkling the content of the capsule(s) over teaspoon of apple sauce or yogurt taken 30 minutes after breakfast.

    Investigational medicinal product name
    tamsulosin hydrochloride (0.4 mg)
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    Subjects who were titrated to high dose level (0.004-0.008 mg/kg) of tamsulosin hydrochloride and body weight of 50.1–100.0 kg received high dose of 0.4 mg qd by sprinkling the content of the capsule(s) over teaspoon of apple sauce or yogurt taken 30 minutes after breakfast.

    Number of subjects in period 2
    tamsulosin - low dose level (Group D-Denovo) tamsulosin - medium dose level (Group D-Denovo) tamsulosin - high dose level (Group D-Denovo)
    Started
    29
    21
    37
    PK Study Subjects Entered Group D-Denovo
    7 [1]
    5 [2]
    18 [3]
    Completed
    27
    16
    30
    Not completed
    2
    5
    7
         Protocol deviation
    -
    -
    1
         Adverse event, non-fatal
    2
    4
    -
         Other reason not defined above
    -
    -
    3
         Consent withdrawn by subject
    -
    1
    3
    Notes
    [1] - The number of subjects at this milestone seems inconsistent with the number of subjects in the arm. It is expected that the number of subjects will be greater than, or equal to the number that completed, minus those who left.
    Justification: Three different Clinical trial reports were prepared based on 3 separate populations (PK/PD, Group D-Denovo & Group D-527.51). Group D-Denovo includes patients from PK Phase & additional subjects. Thus this milestone represents the number of PK Study Subjects who Entered Group D-Denovo and treated for tamsulosin - low dose level.
    [2] - The number of subjects at this milestone seems inconsistent with the number of subjects in the arm. It is expected that the number of subjects will be greater than, or equal to the number that completed, minus those who left.
    Justification: Three different Clinical trial reports were prepared based on 3 separate populations (PK/PD, Group D-Denovo & Group D-527.51). Group D-Denovo includes patients from PK Phase & additional subjects. Thus this milestone represents the number of PK Study Subjects who Entered Group D-Denovo and treated for tamsulosin - medium dose level.
    [3] - The number of subjects at this milestone seems inconsistent with the number of subjects in the arm. It is expected that the number of subjects will be greater than, or equal to the number that completed, minus those who left.
    Justification: Three different Clinical trial reports were prepared based on 3 separate populations (PK/PD, Group D-Denovo & Group D-527.51). Group D-Denovo includes patients from PK Phase & additional subjects. Thus this milestone represents the number of PK Study Subjects who Entered Group D-Denovo and treated for tamsulosin - high dose level.
    Period 3
    Period 3 title
    Group D-Rollover (Treatment period)
    Is this the baseline period?
    Yes [4]
    Allocation method
    Not applicable
    Blinding used
    Not blinded

    Arms
    Are arms mutually exclusive
    No

    Arm title
    tamsulosin - low dose level (Group D-527.51 Rollover)
    Arm description
    Subjects received low dose level (0.001–0.002 mg/kg) of tamsulosin hydrochloride, once daily dependent on a subject's body weight. In Group D- 527.51 Rollover, once subjects exited the double-blind trial they were rolled over into this trial (527.66). All subjects were to titrate to their efficacious dose. Doses that were available were based on subject's weight. Depending on the LPP results, subjects could remain on that dose if it was found to be efficacious or titrate up in hopes that that the higher doses would provide some efficacy. Subjects with body weight of 12.1-25.0 kg received low dose of 0.025 mg qd, body weight of 25.1-50.0 kg received low dose of 0.05 mg qd and body weight of 50.1-100.0 kg qd received low dose of 0.1 mg qd by sprinkling the content of the capsule(s) over teaspoon of apple sauce or yogurt, taken 30 minutes after breakfast.
    Arm type
    Experimental

    Investigational medicinal product name
    tamsulosin hydrochloride (0.025 mg)
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    Subjects with body weight of 12.1– 25.0 kg received low dose of 0.025 mg qd of tamsulosin hydrochloride by sprinkling the content of the capsule(s) over teaspoon of apple sauce or yogurt taken 30 minutes after breakfast.

    Investigational medicinal product name
    tamsulosin hydrochloride (0.05 mg)
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    Subjects with body weight of 25.1–50.0 kg received low dose of 0.05 mg qd of tamsulosin hydrochloride by sprinkling the content of the capsule(s) over teaspoon of apple sauce or yogurt taken 30 minutes after breakfast.

    Investigational medicinal product name
    tamsulosin hydrochloride (0.1 mg)
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    Subjects with body weight of 50.1–100.0 kg received low dose of 0.1 mg qd of tamsulosin hydrochloride by sprinkling the content of the capsule(s) over teaspoon of apple sauce or yogurt taken 30 minutes after breakfast.

    Arm title
    tamsulosin - medium dose level (Group D-527.51 Rollover)
    Arm description
    Subjects who were to receive medium dose level (0.002-0.004 mg/kg) of tamsulosin hydrochloride, once daily dependent on a subject's body weight. In Group D-527.51 Rollover, once subjects exited the double-blind trial they were rolled over into this trial. All subjects were to titrate to their efficacious dose. Doses that were available were based on subject's weight. Depending on the LPP results, subjects could remain on that dose if it was found to be efficacious or titrate up in hopes that the higher doses would provide some efficacy. Subjects with body weight of 9.0-12.0 kg received medium dose of 0.025 mg qd, body weight of 12.1-25.0 kg received medium dose of 0.05 mg qd , body weight of 25.1-50.0 kg received medium dose of 0.1 mg qd, body weight of 50.1-100.0 kg received medium dose of 0.2 mg qd by sprinkling the content of the capsule(s) over teaspoon of apple sauce or yogurt taken 30 minutes after breakfast.
    Arm type
    Experimental

    Investigational medicinal product name
    tamsulosin hydrochloride (0.025 mg)
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    Subjects received medium dose level (0.002–0.004 mg/kg) of tamsulosin hydrochloride and body weight of 9.0–12.0 kg received medium dose of 0.025 mg qd by sprinkling the content of the capsule(s) over teaspoon of apple sauce or yogurt taken 30 minutes after breakfast.

    Investigational medicinal product name
    tamsulosin hydrochloride (0.05 mg)
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    Subjects who were titrated to medium dose level (0.002–0.004 mg/kg) of tamsulosin hydrochloride and body weight of 12.1–25.0 kg received medium dose of 0.05 mg qd by sprinkling the content of the capsule(s) over teaspoon of apple sauce or yogurt taken 30 minutes after breakfast.

    Investigational medicinal product name
    tamsulosin hydrochloride (0.1 mg)
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    Subjects who were titrated to medium dose level (0.002–0.004 mg/kg) of tamsulosin hydrochloride and body weight of 25.1–50.0 kg received medium dose of 0.1 mg qd by sprinkling the content of the capsule(s) over teaspoon of apple sauce or yogurt taken 30 minutes after breakfast.

    Investigational medicinal product name
    tamsulosin hydrochloride (0.2 mg)
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    Subjects who were titrated to medium dose level (0.002–0.004 mg/kg) of tamsulosin hydrochloride and body weight of 50.1–100.0 kg received medium dose of 0.2 mg qd by sprinkling the content of the capsule(s) over teaspoon of apple sauce or yogurt taken 30 minutes after breakfast.

    Arm title
    tamsulosin - high dose level (Group D-527.51 Rollover)
    Arm description
    Subjects titrated to high dose level (0.004-0.008 mg/kg) of tamsulosin hydrochloride, once daily dependent on a subject's body weight. In Group D-527.51 Rollover, once subjects exited the double-blind trial they were rolled over into this trial. All subjects had to titrate to their efficacious dose. Doses that were available were based on subject's weight. Depending on the LPP results, subjects could remain on that dose if it was found to be efficacious or titrate up in hopes that the higher doses would provide some efficacy. Subjects with body weight of 9.0-12.0 kg received high dose of 0.05 mg, body weight of 12.1-25.0 kg received high dose of 0.1 mg, body weight of 25.1-50.0 kg received high dose of 0.2 mg, body weight of 50.1-100.0 kg received high dose of 0.4 mg by sprinkling the content of the capsule(s) over teaspoon of apple sauce or yogurt taken 30 minutes after breakfast.
    Arm type
    Experimental

    Investigational medicinal product name
    tamsulosin hydrochloride (0.05 mg)
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    Subjects who were titrated to high dose level (0.004-0.008 mg/kg) of tamsulosin hydrochloride and body weight of 9.0–12.0 kg received high dose of 0.05 mg qd by sprinkling the content of the capsule(s) over teaspoon of apple sauce or yogurt taken 30 minutes after breakfast.

    Investigational medicinal product name
    tamsulosin hydrochloride (0.1 mg)
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    Subjects who were titrated to high dose level (0.004-0.008 mg/kg) of tamsulosin hydrochloride and body weight of 12.1–25.0 kg received high dose of 0.1 mg qd by sprinkling the content of the capsule(s) over teaspoon of apple sauce or yogurt taken 30 minutes after breakfast.

    Investigational medicinal product name
    tamsulosin hydrochloride (0.2 mg)
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    Subjects who were titrated to high dose level (0.004-0.008 mg/kg) of tamsulosin hydrochloride and body weight of 25.1–50.0 kg received high dose of 0.2 mg qd by sprinkling the content of the capsule(s) over teaspoon of apple sauce or yogurt taken 30 minutes after breakfast.

    Investigational medicinal product name
    tamsulosin hydrochloride (0.4 mg)
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    Subjects who were titrated to high dose level (0.004-0.008 mg/kg) of tamsulosin hydrochloride and body weight of 50.1–100.0 kg received high dose of 0.4 mg qd by sprinkling the content of the capsule(s) over teaspoon of apple sauce or yogurt taken 30 minutes after breakfast.

    Notes
    [4] - Period 1 is not the baseline period. It is expected that period 1 will be the baseline period.
    Justification: Three separate reports were prepared for this study evaluating 3 different populations: PK sub-study, Group D-Denovo and the Group D Rollover (included subjects who entered Study 527.66 from Study 527.51). Since period 1 evaluates only the PK sub-study population, Group D-Rollover baseline data information was selected to be used for this evaluation.
    Number of subjects in period 3
    tamsulosin - low dose level (Group D-527.51 Rollover) tamsulosin - medium dose level (Group D-527.51 Rollover) tamsulosin - high dose level (Group D-527.51 Rollover)
    Started
    54
    13
    29
    Completed
    1
    1
    0
    Not completed
    53
    12
    29
         Adverse event, non-fatal
    -
    1
    1
         Other reason not defined above
    53
    11
    28

    Baseline characteristics

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    Baseline characteristics reporting groups [1]
    Reporting group title
    Group D-Rollover (Treatment period)
    Reporting group description
    -

    Notes
    [1] - The number of subjects reported to be in the baseline period is not equal to the worldwide number of subjects enrolled in the trial. It is expected that these numbers will be the same.
    Justification: Baseline characteristics are based on the subjects who were randomised after successfully completing the screening period and received at least one dose of the trial medication (Group D-Rollover).
    Reporting group values
    Group D-Rollover (Treatment period) Total
    Number of subjects
    96 96
    Age categorical
    Units: Subjects
    Age continuous
    Treated Set: Includes all patients who are dispensed study medication and are documented to have taken at least one dose of treatment. In this study, some of the subjects are in multiple phases: PK and Group D-Denovo. Thus, the baseline characteristics are based on the unique subject entered into the study.
    Units: years
        arithmetic mean (standard deviation)
    8 ± 3.8 -
    Gender categorical
    Units: Subjects
        Female
    41 41
        Male
    55 55
    Subject analysis sets

    Subject analysis set title
    PK Study - Single dose (Treatment period)
    Subject analysis set type
    Intention-to-treat
    Subject analysis set description
    The subject analysis type is infact Pharmacokinetics single dose set (PK-SD). Subjects received low dose level (0.001 – 0.002 mg/kg) of tamsulosin hydrochloride once daily dependent on a subject's body weight (12.1 – 25.0 kg, 25.1 – 50.0 kg and 50.1 – 100.0 kg), by sprinkling the content of the capsule(s) over teaspoon of apple sauce or yogurt, taken 30 minutes after breakfast. All subjects who were randomized, successfully took and retained the first dose of study medication and provided blood samples for PK after single dose were included in the PK-SD set. In PK Single dose study, it was planned to obtain the Low dose PK data after single dose from all the 30 patients randomized to Low, Medium and high. However as per the protocol amendment, the PK sampling after first drug administration of low dose level was stopped after inclusion of 11 patients and therefore the PK sample of 11 patients were evaluated for PK single dose.

    Subject analysis set title
    PK Study - Steady state (Treatment period)
    Subject analysis set type
    Intention-to-treat
    Subject analysis set description
    The subject analysis type is infact pharmacokinetics steady state set (PK-SS). In PK study - steady state, all subjects were titrated to their randomized dose level that they needed to receive which was based on their weight. Depending on the results of the Leak point pressure (LPP) results, subjects could remain on that dose if it was found to be efficacious or go back to a lower efficacious dose or titrate up in hopes that the higher dose would provide some efficacy. pharmacokinetics steady state set (PK-SS): Includes all subjects who were randomized successfully took study medication for two weeks at their randomized dose level and provided blood samples for PK at their steady state visit were included in the PK-SS set.

    Subject analysis set title
    D-Denovo (Treatment Period)
    Subject analysis set type
    Intention-to-treat
    Subject analysis set description
    The subject analysis type is in fact Treated set. In Group D-Denovo, all subjects started the study at the Low Dose level, with the exception of the children with a body weight between 9 kg and 12 kg (they started at the Medium Dose level), and titrated up to higher dose levels on a weekly basis until an efficacious level was reached. The subjects remained on their efficacious dose level for the remainder of the study. Treated set (Treat): Includes all subjects who are dispensed study medication and are documented to have taken at least one dose of treatment.

    Subject analysis sets values
    PK Study - Single dose (Treatment period) PK Study - Steady state (Treatment period) D-Denovo (Treatment Period)
    Number of subjects
    11
    29
    87
    Age categorical
    Units: Subjects
    Age continuous
    Treated Set: Includes all patients who are dispensed study medication and are documented to have taken at least one dose of treatment. In this study, some of the subjects are in multiple phases: PK and Group D-Denovo. Thus, the baseline characteristics are based on the unique subject entered into the study.
    Units: years
        arithmetic mean (standard deviation)
    6.5 ± 4.3
    8 ± 3.8
    7.4 ± 3.7
    Gender categorical
    Units: Subjects
        Female
    5
    13
    42
        Male
    6
    16
    45

    End points

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    End points reporting groups
    Reporting group title
    tamsulosin - low dose level (Steady State - PK study)
    Reporting group description
    Subjects randomized to low dose level (0.001–0.002 mg/kg) of tamsulosin hydrochloride, dependent on a subject's body weight. In PK study, all subjects were titrated to their randomized dose level that they needed to receive which was based on their weight. Depending on the results of the Leak point pressure (LPP) results, subjects could remain on that dose if it was found to be efficacious or go back to a lower efficacious dose or titrate up in hopes that the higher dose would provide some efficacy. Subjects with body weight of 12.1–25.0 kg received low dose of 0.025 mg qd (once daily), body weight of 25.1–50.0 kg received low dose of 0.05 mg qd and body weight of 50.1–100.0 kg received low dose of 0.1 mg qd by sprinkling the content of the capsule(s) over teaspoon of apple sauce or yogurt taken 30 minutes after breakfast.

    Reporting group title
    tamsulosin - medium dose level (Steady State - PK study)
    Reporting group description
    Subjects randomized to medium dose level (0.002–0.004 mg/kg) of tamsulosin hydrochloride, dependent on a subject's body weight. In PK study, all subjects were titrated to their randomized dose level that they needed to receive which was based on their weight. Depending on the results of the LPP results, subjects could remain on that dose if it was found to be efficacious or go back to a lower efficacious dose or titrate up in hopes that the higher dose would provide some efficacy. Subjects with body weight of 12.1–25.0 kg received medium dose of 0.05 mg qd, body weight of 25.1–50.0 kg received medium dose of 0.1 mg qd with and body weight of 50.1–100.0 kg received medium dose of 0.2 mg qd by sprinkling the content of the capsule(s) over teaspoon of apple sauce or yogurt, taken 30 minutes after breakfast.

    Reporting group title
    tamsulosin - high dose level (Steady State - PK study)
    Reporting group description
    Subjects randomized to high dose level(0.004-0.008mg/kg) of tamsulosin hydrochloride,dependent on a subject's body weight.In PK study,all subjects were titrated to their randomized dose level that they needed to receive which was based on their weight.Depending on the results of the LPP,subjects could remain on that dose if it was found to be efficacious or go back to a lower efficacious dose or titrate up in hopes that the higher dose would provide some efficacy. Subjects with body weight of 12.1-25.0kg received high dose of 0.1mg qd, body weight of 25.1-50.0kg received high dose of 0.2mg qd & body weight of 50.1-100.0kg received high dose of 0.4mg qd by sprinkling the content of the capsule(s) over teaspoon of apple sauce or yogurt taken 30 minutes after breakfast.One subject randomised to high dose level was not treated. Although actual number of subjects started is 11,10 were reported to ensure consistent reporting with baseline characteristics that includes only treated subjects.
    Reporting group title
    tamsulosin - low dose level (Group D-Denovo)
    Reporting group description
    Subjects received low dose level (0.001 – 0.002 mg/kg) of tamsulosin hydrochloride, dependent on a subject's body weight. In Group D-Denovo, all subjects started the study at the low Dose level, with the exception of the children with a body weight between 9 kg and 12 kg (they started at the Medium Dose level), and titrated up to higher dose levels on a weekly basis until an efficacious level was reached. The subjects remained on their efficacious dose level for the remainder of the study. Subjects with body weight of 12.1– 25.0 kg received low dose of 0.025 mg qd, body weight of 25.1–50.0 kg received low dose of 0.05 mg qd and body weight of 50.1–100.0 kg received low dose of 0.1 mg qd by sprinkling the content of the capsule(s) over teaspoon of apple sauce or yogurt taken 30 minutes after breakfast.

    Reporting group title
    tamsulosin - medium dose level (Group D-Denovo)
    Reporting group description
    Subjects who were titrated to medium dose level (0.002–0.004 mg/kg) of tamsulosin hydrochloride, dependent on a subject's body weight. In Group D-Denovo, all subjects started the study at the Low Dose level, with the exception of the children with a body weight between 9 kg and 12 kg (they started at the Medium Dose level), and titrated up to higher dose levels on a weekly basis until an efficacious level was reached. The subjects remained on their efficacious dose level for the remainder of the study. Subjects with body weight of 9.0–12.0 kg received medium dose of 0.025 mg qd as their starting dose, body weight of 12.1-25.0 kg could have titrated to a medium dose of 0.05 mg qd, body weight of 25.1–50.0 kg could have titrated to a medium dose of 0.1 mg qd and body weight of 50.1–100.0 kg could have titrated to a medium dose of 0.2 mg qd by sprinkling the content of the capsule(s) over teaspoon of apple sauce or yogurt, taken 30 minutes after breakfast.

    Reporting group title
    tamsulosin - high dose level (Group D-Denovo)
    Reporting group description
    Subjects titrated to high dose level (0.004-0.008 mg/kg) of tamsulosin hydrochloride, once daily dependent on a subject's body weight. In Group D-Denovo, all subjects started the study at the Low Dose level, with the exception of the children with a body weight between 9 kg and 12 kg (they started at the Medium Dose level), and titrated up to higher dose levels on a weekly basis until an efficacious level was reached. The subjects remained on their efficacious dose level for the remainder of the study. Subjects with body weight of 9.0-12.0 kg received high dose of 0.05 mg qd, body weight of 12.1-25.0 kg received high dose of 0.1 mg qd, body weight of 25.1-50.0 kg received high dose of 0.2 mg qd & body weight of 50.1-100.0 kg received high dose of 0.4 mg qd by sprinkling the content of the capsule(s) over teaspoon of apple sauce or yogurt, taken 30 minutes after breakfast.
    Reporting group title
    tamsulosin - low dose level (Group D-527.51 Rollover)
    Reporting group description
    Subjects received low dose level (0.001–0.002 mg/kg) of tamsulosin hydrochloride, once daily dependent on a subject's body weight. In Group D- 527.51 Rollover, once subjects exited the double-blind trial they were rolled over into this trial (527.66). All subjects were to titrate to their efficacious dose. Doses that were available were based on subject's weight. Depending on the LPP results, subjects could remain on that dose if it was found to be efficacious or titrate up in hopes that that the higher doses would provide some efficacy. Subjects with body weight of 12.1-25.0 kg received low dose of 0.025 mg qd, body weight of 25.1-50.0 kg received low dose of 0.05 mg qd and body weight of 50.1-100.0 kg qd received low dose of 0.1 mg qd by sprinkling the content of the capsule(s) over teaspoon of apple sauce or yogurt, taken 30 minutes after breakfast.

    Reporting group title
    tamsulosin - medium dose level (Group D-527.51 Rollover)
    Reporting group description
    Subjects who were to receive medium dose level (0.002-0.004 mg/kg) of tamsulosin hydrochloride, once daily dependent on a subject's body weight. In Group D-527.51 Rollover, once subjects exited the double-blind trial they were rolled over into this trial. All subjects were to titrate to their efficacious dose. Doses that were available were based on subject's weight. Depending on the LPP results, subjects could remain on that dose if it was found to be efficacious or titrate up in hopes that the higher doses would provide some efficacy. Subjects with body weight of 9.0-12.0 kg received medium dose of 0.025 mg qd, body weight of 12.1-25.0 kg received medium dose of 0.05 mg qd , body weight of 25.1-50.0 kg received medium dose of 0.1 mg qd, body weight of 50.1-100.0 kg received medium dose of 0.2 mg qd by sprinkling the content of the capsule(s) over teaspoon of apple sauce or yogurt taken 30 minutes after breakfast.

    Reporting group title
    tamsulosin - high dose level (Group D-527.51 Rollover)
    Reporting group description
    Subjects titrated to high dose level (0.004-0.008 mg/kg) of tamsulosin hydrochloride, once daily dependent on a subject's body weight. In Group D-527.51 Rollover, once subjects exited the double-blind trial they were rolled over into this trial. All subjects had to titrate to their efficacious dose. Doses that were available were based on subject's weight. Depending on the LPP results, subjects could remain on that dose if it was found to be efficacious or titrate up in hopes that the higher doses would provide some efficacy. Subjects with body weight of 9.0-12.0 kg received high dose of 0.05 mg, body weight of 12.1-25.0 kg received high dose of 0.1 mg, body weight of 25.1-50.0 kg received high dose of 0.2 mg, body weight of 50.1-100.0 kg received high dose of 0.4 mg by sprinkling the content of the capsule(s) over teaspoon of apple sauce or yogurt taken 30 minutes after breakfast.

    Subject analysis set title
    PK Study - Single dose (Treatment period)
    Subject analysis set type
    Intention-to-treat
    Subject analysis set description
    The subject analysis type is infact Pharmacokinetics single dose set (PK-SD). Subjects received low dose level (0.001 – 0.002 mg/kg) of tamsulosin hydrochloride once daily dependent on a subject's body weight (12.1 – 25.0 kg, 25.1 – 50.0 kg and 50.1 – 100.0 kg), by sprinkling the content of the capsule(s) over teaspoon of apple sauce or yogurt, taken 30 minutes after breakfast. All subjects who were randomized, successfully took and retained the first dose of study medication and provided blood samples for PK after single dose were included in the PK-SD set. In PK Single dose study, it was planned to obtain the Low dose PK data after single dose from all the 30 patients randomized to Low, Medium and high. However as per the protocol amendment, the PK sampling after first drug administration of low dose level was stopped after inclusion of 11 patients and therefore the PK sample of 11 patients were evaluated for PK single dose.

    Subject analysis set title
    PK Study - Steady state (Treatment period)
    Subject analysis set type
    Intention-to-treat
    Subject analysis set description
    The subject analysis type is infact pharmacokinetics steady state set (PK-SS). In PK study - steady state, all subjects were titrated to their randomized dose level that they needed to receive which was based on their weight. Depending on the results of the Leak point pressure (LPP) results, subjects could remain on that dose if it was found to be efficacious or go back to a lower efficacious dose or titrate up in hopes that the higher dose would provide some efficacy. pharmacokinetics steady state set (PK-SS): Includes all subjects who were randomized successfully took study medication for two weeks at their randomized dose level and provided blood samples for PK at their steady state visit were included in the PK-SS set.

    Subject analysis set title
    D-Denovo (Treatment Period)
    Subject analysis set type
    Intention-to-treat
    Subject analysis set description
    The subject analysis type is in fact Treated set. In Group D-Denovo, all subjects started the study at the Low Dose level, with the exception of the children with a body weight between 9 kg and 12 kg (they started at the Medium Dose level), and titrated up to higher dose levels on a weekly basis until an efficacious level was reached. The subjects remained on their efficacious dose level for the remainder of the study. Treated set (Treat): Includes all subjects who are dispensed study medication and are documented to have taken at least one dose of treatment.

    Primary: Percentage of LLP responders for Group D-Denovo and Group D-527.51 Rollover

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    End point title
    Percentage of LLP responders for Group D-Denovo and Group D-527.51 Rollover [1]
    End point description
    Group D-Denovo: Leak point pressure (LPP) Response at (response defined as a subject who achieves an LPP pressure <40 cm H2O) end of treatment based on two confirmatory values. Group D-527.51 Rollover: Leak point pressure (LPP) Response at (response defined as a subject who achieves an LPP pressure <40 cm H2O) last value of the treatment based on two confirmatory values. The last value on treatment included any final value prior to discontinuation of treatment,regardless of the length of treatment. Detrusor leak point pressure (LPP) recorded in cm H2O which was obtained using a standard urodynamic technique,a cystometrogram. Descriptive statistics were used to assess this endpoint.This Outcome Measure was only prespecified for Group D-Denovo & Group D-527.51 Rollover subjects,so results of these two groups are provided. Full Analysis Set for LPP (FAS-LPP): This subject set includes all subjects in Treated set who received one dose of treatment & had one on treatment LPP measurement.
    End point type
    Primary
    End point timeframe
    Group D-Denovo: Week 52. Group D-527.51 Rollover: Week 1, Week 2, Week 3 and Week 4 prior to dose administration and Week 9 (optional), Week 13 (additional), Week 26 (optional) and Week 52 after drug administration.
    Notes
    [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: This endpoint was evaluated only descriptively. Thus, no statistical hypothesis test was tested.
    End point values
    tamsulosin - low dose level (Group D-Denovo) tamsulosin - low dose level (Group D-527.51 Rollover) tamsulosin - medium dose level (Group D-Denovo) tamsulosin - medium dose level (Group D-527.51 Rollover) tamsulosin - high dose level (Group D-Denovo) tamsulosin - high dose level (Group D-527.51 Rollover)
    Number of subjects analysed
    26 [2]
    53 [3]
    14 [4]
    12 [5]
    30 [6]
    29 [7]
    Units: percentage of responders
        number (not applicable)
    73.1
    67.9
    35.7
    58.3
    26.7
    20.7
    Notes
    [2] - FAS-LPP
    [3] - FAS-LPP
    [4] - FAS-LPP
    [5] - FAS-LPP
    [6] - FAS-LPP
    [7] - FAS-LPP
    No statistical analyses for this end point

    Primary: Number of LPP responders at each visit over time (classified by last value on treatment) for Group D-527.51 Rollover

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    End point title
    Number of LPP responders at each visit over time (classified by last value on treatment) for Group D-527.51 Rollover [8]
    End point description
    Number of Leak point pressure (LPP) Responders at each visit (week) over time (classified by last value on treatment). Due to the early termination of the study, most of the LPP assessments were conducted within Weeks 1-9 of treatment. Summary of LPP response rates provided over time.The subjects are classified according to the treatment they were receiving at the last value on treatment. Therefore, no assumptions can be made regarding what dose they were receiving at a particular time point. LD: Low dose; MD: Medium dose; HD: High dose. This Outcome Measure was only pre-specified for Group D-527.51 Rollover subjects, so results of this group is provided.
    End point type
    Primary
    End point timeframe
    Week 1 (Visit 3) , Week 2 (Visit 4) , Week 3 (Visit 5) and Week 4 (Visit 6) prior to dose administration and Week 9 (Visit 7) (optional), Week 13 (Visit 8) (additional), Week 26 (Visit 9) (optional) and Week 52 (Visit 11) after drug administration.
    Notes
    [8] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: This endpoint was evaluated only descriptively. Thus, no statistical hypothesis test was tested.
    End point values
    tamsulosin - low dose level (Group D-527.51 Rollover) tamsulosin - medium dose level (Group D-527.51 Rollover) tamsulosin - high dose level (Group D-527.51 Rollover)
    Number of subjects analysed
    53 [9]
    12 [10]
    29 [11]
    Units: Participants
    number (not applicable)
        Week 1 (N= 40 (LD), 12 (MD), 27 (HD))
    38
    1
    0
        Week 2 (N= 2 (LD), 7 (MD), 27 (HD))
    2
    7
    2
        Week 3 (N= 3 (LD), 0 (MD), 22 (HD))
    2
    0
    5
        Week 4 (N= 1 (LD), 0 (MD), 3 (HD))
    1
    0
    0
        Week 9 (N= 7 (LD), 2 (MD), 16 (HD))
    5
    2
    5
        Week 13 (N= 4 (LD), 0 (MD), 2 (HD))
    1
    0
    1
        Week 26 (N= 2 (LD), 0 (MD), 3 (HD))
    1
    0
    1
        Week 52 (N= 1 (LD), 1 (MD), 0 (HD))
    1
    1
    0
    Notes
    [9] - FAS-LPP
    [10] - FAS-LPP
    [11] - FAS-LPP
    No statistical analyses for this end point

    Secondary: Early responders who maintained their LPP below 40 cm H2O during the study for Group D-Denovo and Group D-527.51 Rollover

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    End point title
    Early responders who maintained their LPP below 40 cm H2O during the study for Group D-Denovo and Group D-527.51 Rollover
    End point description
    Early responders who maintained their detrusor LPP below 40 cm H2O during the study. Timeframe for Group D-Denovo: Low dose: Week (wk) 1, 3 & 4 prior to dose and Week 2, 9 & 26 (optional), 13(additional) & 52 post dose. Medium dose: Week 1, 2 & 4 prior to dose and Week 3, 9(optional), 13(additional), 26 (optional) & 52 post dose. High dose: Week 1, 2 & 3 prior to dose administration and Week 4, 9(optional), 13(additional), 26 (optional) & 52 post dose. Group D-527.51 Rollover: Week 1, 2, 3 & 4 prior to dose and Week 9 &26 (optional),13 (additional) & 52 post dose. This Outcome Measure was only pre-specified for Group D-Denovo and Group D-527.51 Rollover subjects, However this endpoint was analysed for the Group D-Denovo and it was not analysed for Group D-527.51 Rollover as very limited data were collected due to the early termination of the study and no alternative endpoint was also defined in the Group D-527.51 rollover, so only the results for Group D-Denovo is provided.
    End point type
    Secondary
    End point timeframe
    Week 1 to Week 52 (Time frame for all weeks are described study wise in the Description).
    End point values
    tamsulosin - low dose level (Group D-Denovo) tamsulosin - low dose level (Group D-527.51 Rollover) tamsulosin - medium dose level (Group D-Denovo) tamsulosin - medium dose level (Group D-527.51 Rollover) tamsulosin - high dose level (Group D-Denovo) tamsulosin - high dose level (Group D-527.51 Rollover)
    Number of subjects analysed
    28 [12]
    0 [13]
    21 [14]
    0 [15]
    37 [16]
    0 [17]
    Units: Participants
        number (not applicable)
    17
    5
    3
    Notes
    [12] - FAS-LPP
    [13] - This endpoint was not analysed due to insufficient data so no results have been analysed.
    [14] - FAS-LPP
    [15] - This endpoint was not analysed due to insufficient data so no results have been analysed.
    [16] - FAS-LPP
    [17] - This endpoint was not analysed due to insufficient data so no results have been analysed.
    No statistical analyses for this end point

    Secondary: Change from baseline in LPP for Group D-527.51 Rollover

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    End point title
    Change from baseline in LPP for Group D-527.51 Rollover
    End point description
    Median change from baseline in detrusor leak point pressure (LPP) by treatment group (subjects are classified according to the treatment they were taking at end of treatment (EOT)) and week. Baseline assessments were obtained from trial 527.51 for Group D-527.51 Rollover. The results from Week 1 were reported because there were very few subjects who reported data at subsequent visits due to the termination of the trial. This Outcome Measure (OM) was only pre-specified for Group D-527.51 Rollover subjects, so results of this group is provided.
    End point type
    Secondary
    End point timeframe
    Baseline and week 1
    End point values
    tamsulosin - low dose level (Group D-527.51 Rollover) tamsulosin - medium dose level (Group D-527.51 Rollover) tamsulosin - high dose level (Group D-527.51 Rollover)
    Number of subjects analysed
    53 [18]
    12 [19]
    29 [20]
    Units: cm H2O
    median (standard deviation)
        Baseline (N= 53 (LD), 12 (MD), 29 (HD))
    48.5 ± 14.47
    48.5 ± 11.19
    55.5 ± 24.52
        Week 1 - Actual (N= 39 (LD), 9 (MD), 22 (HD))
    29 ± 8.5
    49.5 ± 8.3
    64.75 ± 27.2
        Week 1 - Change (N= 39 (LD), 9 (MD), 22 (HD))
    -25.5 ± 15.18
    -2 ± 13.68
    -1.25 ± 24.97
    Notes
    [18] - FAS-LPP
    [19] - FAS-LPP
    [20] - FAS-LPP
    No statistical analyses for this end point

    Secondary: Percent change from baseline in LPP for Group D-527.51 Rollover

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    End point title
    Percent change from baseline in LPP for Group D-527.51 Rollover
    End point description
    Percent change from baseline in actual detrusor leak point pressure (LPP) by treatment group (subjects are classified according to the treatment they were taking at end of treatment) and Week. Baseline assessments were obtained from trial 527.51 for Group D-527.51 Rollover.The results from Week 1 were reported because there were very few subjects who reported data at subsequent visits due to the termination of the trial. This Outcome Measure was only pre-specified for Group D-527.51 Rollover subjects, so results of this group is provided.
    End point type
    Secondary
    End point timeframe
    Baseline and Week 1
    End point values
    tamsulosin - low dose level (Group D-527.51 Rollover) tamsulosin - medium dose level (Group D-527.51 Rollover) tamsulosin - high dose level (Group D-527.51 Rollover)
    Number of subjects analysed
    53 [21]
    12 [22]
    29 [23]
    Units: percent change
    median (standard deviation)
        Baseline (N= 53 (LD), 12 (MD), 29 (HD))
    48.5 ± 14.47
    48.5 ± 11.19
    55.5 ± 24.52
        Week 1 - Actual (N= 39 (LD), 9 (MD), 22 (HD))
    29 ± 8.5
    49.5 ± 8.3
    64.75 ± 27.2
        Week 1 - Change (N= 39 (LD), 9 (MD), 22 (HD))
    -48.48 ± 18.65
    -3.88 ± 22.43
    -2.71 ± 40.41
    Notes
    [21] - FAS-LPP
    [22] - FAS-LPP
    [23] - FAS-LPP
    No statistical analyses for this end point

    Secondary: Response defined as stabilization or improvement of hydroureter measured by renal ultrasound compared to baseline for Group D-Denovo and Group D-527.51 Rollover

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    End point title
    Response defined as stabilization or improvement of hydroureter measured by renal ultrasound compared to baseline for Group D-Denovo and Group D-527.51 Rollover
    End point description
    Response defined as stabilization or improvement of hydroureter measured by renal ultrasound compared to baseline by treatment group(subjects classified according to treatment they were taking at wk 52 or EOT)at wk 52 for Group D-Denovo&(subjects classified according to treatment they were taking at EOT) at LVOT for Group D-527.51Rollover.Baseline assessments were obtained from trial 527.51 for Group D-527.51Rollover.The overall treatment duration was not sufficient to reach any meaningful conclusions regarding improvement or stabilization of hydroureter in Group D-527.51Rollover.Hydroureter response is defined as improvement or stabilization based upon the presence or absence of hydroureter at EOTcompared to baseline.This OM was only pre-specified for Group D-Denovo&Group D-527.51Rollover subjects,so results of these two groups are provided. FAS for Renal (FAS-RENAL): Includes all patients in the Treated set who received one dose of treatment and had one treatment renal measurement.
    End point type
    Secondary
    End point timeframe
    Group D-Denovo: Baseline and Week 52 Group D-527.51 Rollover: Baseline, Week 26 and Week 52.
    End point values
    tamsulosin - low dose level (Group D-Denovo) tamsulosin - low dose level (Group D-527.51 Rollover) tamsulosin - medium dose level (Group D-Denovo) tamsulosin - medium dose level (Group D-527.51 Rollover) tamsulosin - high dose level (Group D-Denovo) tamsulosin - high dose level (Group D-527.51 Rollover)
    Number of subjects analysed
    27 [24]
    44 [25]
    17 [26]
    8 [27]
    34 [28]
    19 [29]
    Units: Participants
        Right Kidney
    26
    43
    15
    8
    28
    19
        Left Kidney
    24
    43
    14
    8
    29
    17
    Notes
    [24] - FAS-RENAL
    [25] - FAS-RENAL
    [26] - FAS-RENAL
    [27] - FAS-RENAL
    [28] - FAS-RENAL
    [29] - FAS-RENAL
    No statistical analyses for this end point

    Secondary: Response defined as stabilization or improvement of hydronephrosis measured by renal ultrasound compared to baseline for Group D-Denovo and Group D-527.51 Rollover

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    End point title
    Response defined as stabilization or improvement of hydronephrosis measured by renal ultrasound compared to baseline for Group D-Denovo and Group D-527.51 Rollover
    End point description
    Response defined as stabilization or improvement of hydronephrosis measured by renal ultrasound compared to baseline by treatment group (subjects are classified according to the treatment they were taking at wk 52 or EOT) at wk 52 for Group D-Denovo & (subjects classified according to the treatment they were taking at EOT) at last value on treatment (LVOT) for Group D-527.51Rollover.Baseline assessments were obtained from trial 527.51 for Group D-527.51Rollover.Overall treatment duration was not sufficient to reach any meaningful conclusions regarding improvement or stabilization of hydronephrosis in the Group D-527.51 ollover.Hydronephrois response is defined as improvement or stabilization based upon ultrasound grading at the end of the study.The lower or same grade at EOT compared to baseline is considered an improvement or stabilization.This Outcome Measure was only pre-specified for Group D-Denovo and Group D-527.51 Rollover subjects, so results of these two groups are provided.
    End point type
    Secondary
    End point timeframe
    Group D-Denovo: Baseline and Week 52. Group D-527.51 Rollover: Baseline, Week 26 and Week 52.
    End point values
    tamsulosin - low dose level (Group D-Denovo) tamsulosin - low dose level (Group D-527.51 Rollover) tamsulosin - medium dose level (Group D-Denovo) tamsulosin - medium dose level (Group D-527.51 Rollover) tamsulosin - high dose level (Group D-Denovo) tamsulosin - high dose level (Group D-527.51 Rollover)
    Number of subjects analysed
    27 [30]
    44 [31]
    17 [32]
    8 [33]
    34 [34]
    19 [35]
    Units: Participants
        Right Kidney
    26
    39
    15
    8
    28
    17
        Left Kidney
    24
    42
    14
    7
    26
    17
    Notes
    [30] - Full analysis set (FAS-RENAL)
    [31] - Full analysis set (FAS-RENAL)
    [32] - Full analysis set (FAS-RENAL)
    [33] - Full analysis set (FAS-RENAL)
    [34] - Full analysis set (FAS-RENAL)
    [35] - Full analysis set (FAS-RENAL)
    No statistical analyses for this end point

    Secondary: LPP response at any time during the trial for Group D-Denovo and Group D-527.51 Rollover

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    End point title
    LPP response at any time during the trial for Group D-Denovo and Group D-527.51 Rollover
    End point description
    Response rates of LPP responders (2 LPP values < 40 cm H2O) at any time during the trial by treatment group. Timeframe for Group D-Denovo: Low dose: Week 1, 3 & 4 prior to dose and Week 2, 9 & 26 (optional), 13(additional) & 52 post dose. Medium dose: Week 1, 2 & 4 prior to dose and Week 3, 9(optional), 13(additional), 26 (optional) & 52 post dose. High dose: Week 1, 2 & 3 prior to dose administration and Week 4, 9(optional), 13(additional), 26 (optional) & 52 post dose. Group D-527.51 Rollover: Week 1, 2, 3 & 4 prior to dose and Week 9 &26 (optional),13 (additional) & 52 post dose. This Outcome Measure was only pre-specified for Group D-Denovo and Group D-527.51 Rollover subjects, so results of these two groups are provided.
    End point type
    Secondary
    End point timeframe
    Week 1 to Week 52 (described study wise in the Description).
    End point values
    tamsulosin - low dose level (Group D-Denovo) tamsulosin - low dose level (Group D-527.51 Rollover) tamsulosin - medium dose level (Group D-Denovo) tamsulosin - medium dose level (Group D-527.51 Rollover) tamsulosin - high dose level (Group D-Denovo) tamsulosin - high dose level (Group D-527.51 Rollover)
    Number of subjects analysed
    28 [36]
    53 [37]
    21 [38]
    12 [39]
    37 [40]
    29 [41]
    Units: participants
    26
    42
    16
    8
    16
    12
    Notes
    [36] - FAS-LPP
    [37] - FAS-LPP
    [38] - FAS-LPP
    [39] - FAS-LPP
    [40] - FAS-LPP
    [41] - FAS-LPP
    No statistical analyses for this end point

    Secondary: Number of participants with Clinically Relevant Abnormalities for Physical Examination, Vital Signs/Orthostatic testing, Electorocardiogram (ECG),Laboratory Values,Urinalysis,Occurence of Adverse events & Cognitive Testing for Group D-527.51 Rollover

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    End point title
    Number of participants with Clinically Relevant Abnormalities for Physical Examination, Vital Signs/Orthostatic testing, Electorocardiogram (ECG),Laboratory Values,Urinalysis,Occurence of Adverse events & Cognitive Testing for Group D-527.51 Rollover
    End point description
    Number of participants with Clinically Relevant Abnormalities for Physical Examination, Vital Signs/Orthostatic testing, Electrocardiogram (ECG), Laboratory Values, Urinalysis, Occurence of Adverse events and Cognitive Testing. Relevant findings or worsening of baseline conditions were reported as adverse events.Below mentioned result are the number of subjects who had the clinical relevant abnormalities for the preferred term 'Hepatic enzyme increased'. This Outcome Measure was only prespecified for Group D-527.51 Rollover subjects, so results of this group is provided.
    End point type
    Secondary
    End point timeframe
    From first drug administration until 28 days after last study drug administration, upto 395 days
    End point values
    tamsulosin - low dose level (Group D-527.51 Rollover) tamsulosin - medium dose level (Group D-527.51 Rollover) tamsulosin - high dose level (Group D-527.51 Rollover)
    Number of subjects analysed
    54 [42]
    13 [43]
    29 [44]
    Units: Participants
        Hepatic enzyme increased
    1
    0
    0
    Notes
    [42] - Treated Set (TS)
    [43] - Treated Set (TS)
    [44] - Treated Set (TS)
    No statistical analyses for this end point

    Secondary: Number of participants with Clinically Relevant Abnormalities for Physical Examination, Vital Signs/Orthostatic testing, Electorocardiogram (ECG), Laboratory Values, Urinalysis, Occurence of Adverse events and Cognitive Testing for Group D-Denovo

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    End point title
    Number of participants with Clinically Relevant Abnormalities for Physical Examination, Vital Signs/Orthostatic testing, Electorocardiogram (ECG), Laboratory Values, Urinalysis, Occurence of Adverse events and Cognitive Testing for Group D-Denovo
    End point description
    Number of participants with Clinically Relevant Abnormalities for Physical Examination, Vital Signs/Orthostatic testing, Electrocardiogram (ECG), Laboratory Values, Urinalysis, Occurence of Adverse events and Cognitive Testing. Relevant findings or worsening of baseline conditions were reported as adverse events. Subjects who experienced orthostatic hypotension during orthostatic testing were reported as adverse events. This Outcome Measure was only pre-specified for Group D-Denovo, so results of this group is provided.
    End point type
    Secondary
    End point timeframe
    From first drug administration until 28 days after last study drug administration, upto 450 days
    End point values
    tamsulosin - low dose level (Group D-Denovo) tamsulosin - medium dose level (Group D-Denovo) tamsulosin - high dose level (Group D-Denovo)
    Number of subjects analysed
    29 [45]
    21 [46]
    37 [47]
    Units: Participants
        Blood urine present
    0
    0
    1
        Body temperature increased
    0
    0
    1
        Orthostatic hypotension
    1
    3
    0
    Notes
    [45] - Treated Set (TS)
    [46] - Treated Set (TS)
    [47] - Treated Set (TS)
    No statistical analyses for this end point

    Secondary: Vision Testing for Group D-527.51 Rollover

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    End point title
    Vision Testing for Group D-527.51 Rollover
    End point description
    Number of subjects with a change from baseline in visual acuity by treatment group (subjects are classified according to the treatment they were taking at end of treatment). They were analysed based on the below mentioned category in both the Eyes: 1) No Change 2) Decrease in visual acuity 3) Increase in visual acuity 4) Missing Missing includes subjects with no baseline exam and subjects with exam scores missing. This Outcome Measure was only pre-specified for Group D-527.51 Rollover subjects, so results of this group is provided.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 26 and Week 52
    End point values
    tamsulosin - low dose level (Group D-527.51 Rollover) tamsulosin - medium dose level (Group D-527.51 Rollover) tamsulosin - high dose level (Group D-527.51 Rollover)
    Number of subjects analysed
    54 [48]
    13 [49]
    29 [50]
    Units: Participants
        Right Eye - No Change
    32
    10
    12
        Right Eye - Decrease in visual acuity
    5
    2
    4
        Right Eye - Increase in visual acuity
    12
    1
    6
        Right Eye - Missing
    5
    0
    7
        Left Eye - No Change
    31
    12
    12
        Left Eye - Decrease in visual acuity
    8
    1
    3
        Left Eye - Increase in visual acuity
    10
    0
    7
        Left Eye - Missing
    5
    0
    7
    Notes
    [48] - Treated Set (TS)
    [49] - Treated Set (TS)
    [50] - Treated Set (TS)
    No statistical analyses for this end point

    Secondary: Vision Testing for Group D-Denovo

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    End point title
    Vision Testing for Group D-Denovo
    End point description
    Number of subjects with a change from baseline in visual acuity by treatment group (subjects are classified according to the treatment they were taking at Week 52 or end of treatment). They were analysed based on the below mentioned category in both the Eyes: 1) No Change 2) Decrease in visual acuity 3) Increase in visual acuity 4) Missing Missing includes subjects with no baseline exam and subjects with exam scores missing. This Outcome Measure was only pre-specified for Group D-Denovo subjects, so results of this group is provided.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 26 and Week 52.
    End point values
    tamsulosin - low dose level (Group D-Denovo) tamsulosin - medium dose level (Group D-Denovo) tamsulosin - high dose level (Group D-Denovo)
    Number of subjects analysed
    29 [51]
    21 [52]
    37 [53]
    Units: Participants
        Right Eye (Week 26) - No Change
    11
    7
    12
        Right Eye (Week 26) - Decrease in visual acuity
    8
    1
    8
        Right Eye (Week 26) - Increase in visual acuity
    8
    4
    11
        Right Eye (Week 26) - Missing
    2
    9
    6
        Left Eye (Week 26) - No Change
    11
    6
    19
        Left Eye (Week 26) - Decrease in visual acuity
    7
    1
    4
        Left Eye (Week 26) - Increase in visual acuity
    9
    5
    8
        Left Eye (Week 26) – Missing
    2
    9
    6
        Right Eye (Week 52) - No Change
    7
    6
    16
        Right Eye (Week 52) - Decrease in visual acuity
    10
    2
    4
        Right Eye (Week 52) - Increase in visual acuity
    11
    6
    12
        Right Eye (Week 52) - Missing
    1
    7
    5
        Left Eye (Week 52) - No Change
    11
    5
    12
        Left Eye (Week 52) - Decrease in visual acuity
    6
    3
    6
        Left Eye (Week 52) - Increase in visual acuity
    11
    7
    14
        Left Eye (Week 52) - Missing
    1
    6
    5
    Notes
    [51] - Treated Set (TS)
    [52] - Treated Set (TS)
    [53] - Treated Set (TS)
    No statistical analyses for this end point

    Secondary: Cmax,1

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    End point title
    Cmax,1
    End point description
    Maximum measured concentration of the analyte in plasma following the first dose, Cmax,1. Pharmacokinetics single dose set (PK-SD): This set includes subjects who were randomized, successfully took and retained the first dose of study medication and provided blood samples for PK at Visit 2. This Outcome Measure was only pre-specified for PK Study- single dose group subjects, so results of this group is provided.
    End point type
    Secondary
    End point timeframe
    −0.25h prior to dose and 2h, 4h, 6h and 8h after the drug administration.
    End point values
    PK Study - Single dose (Treatment period)
    Number of subjects analysed
    11 [54]
    Units: ng/mL
        geometric mean (geometric coefficient of variation)
    1.67 ± 68.8
    Notes
    [54] - Pharmacokinetics single dose set (PK-SD)
    No statistical analyses for this end point

    Secondary: tmax, 1

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    End point title
    tmax, 1
    End point description
    Time from dosing to maximum measured concentration of the analyte in plasma after administration of the first dose, tmax, 1. This Outcome Measure was only pre-specified for PK Study- single dose group subjects, so results of this group is provided.
    End point type
    Secondary
    End point timeframe
    −0.25h prior to dose and 2h, 4h, 6h and 8h after the drug administration.
    End point values
    PK Study - Single dose (Treatment period)
    Number of subjects analysed
    11 [55]
    Units: hours
        median (full range (min-max))
    6 (2 to 8)
    Notes
    [55] - Pharmacokinetics single dose set (PK-SD)
    No statistical analyses for this end point

    Secondary: Cmax, 1 ,DW ,norm

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    End point title
    Cmax, 1 ,DW ,norm
    End point description
    Dose- and weight-normalized Cmax,1 (Cmax,1,DW,norm). Weight normalization of Cmax,1 was performed by dividing the respective quantities by the reciprocal of body weight in kg. This Outcome Measure was only pre-specified for PK Study- single dose group subjects, so results of this group is provided.
    End point type
    Secondary
    End point timeframe
    −0.25h prior to dose and 2h, 4h, 6h and 8h after the drug administration.
    End point values
    PK Study - Single dose (Treatment period)
    Number of subjects analysed
    11 [56]
    Units: ng/mL/mg*kg
        geometric mean (geometric coefficient of variation)
    1120 ± 67.2
    Notes
    [56] - Pharmacokinetics single dose set (PK-SD)
    No statistical analyses for this end point

    Secondary: Cpre,ss

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    End point title
    Cpre,ss
    End point description
    Pre-dose concentration of the analyte in plasma at steady state immediately before administration of the next dose, Cpre,ss. Pharmacokinetics steady state set (PK-SS): This set includes subjects who were randomized successfully took study medication for two weeks at their randomized dose level and provided blood samples for PK at their steady state visit. This Outcome Measure was only pre-specified for PK Study- steady state group subjects, so results of this group is provided.
    End point type
    Secondary
    End point timeframe
    −0.25h prior to dose and 2h, 4h, 6h, 8h, 10h, 24h and 33h after the drug administration.
    End point values
    tamsulosin - low dose level (Steady State - PK study) tamsulosin - medium dose level (Steady State - PK study) tamsulosin - high dose level (Steady State - PK study)
    Number of subjects analysed
    9 [57]
    9 [58]
    10 [59]
    Units: ng/mL
        geometric mean (geometric coefficient of variation)
    0.914 ± 159
    1.83 ± 131
    4.03 ± 70.6
    Notes
    [57] - pharmacokinetics steady state set (PK-SS)
    [58] - Pharmacokinetics steady state set (PK-SS)
    [59] - Pharmacokinetics steady state set (PK-SS)
    No statistical analyses for this end point

    Secondary: Cmax,ss

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    End point title
    Cmax,ss
    End point description
    Maximum measured concentration of the analyte in plasma at steady state over a uniform dosing interval τ, Cmax,ss. This Outcome Measure was only pre-specified for PK Study- steady state group subjects, so results of this group is provided.
    End point type
    Secondary
    End point timeframe
    −0.25h prior to dose and 2h, 4h, 6h, 8h, 10h, 24h and 33h after the drug administration.
    End point values
    tamsulosin - low dose level (Steady State - PK study) tamsulosin - medium dose level (Steady State - PK study) tamsulosin - high dose level (Steady State - PK study)
    Number of subjects analysed
    10 [60]
    9 [61]
    10 [62]
    Units: ng/mL
        geometric mean (geometric coefficient of variation)
    2.79 ± 59.5
    5.02 ± 94.8
    14.1 ± 50.3
    Notes
    [60] - Pharmacokinetics steady state set (PK-SS)
    [61] - Pharmacokinetics steady state set (PK-SS)
    [62] - Pharmacokinetics steady state set (PK-SS)
    Statistical analysis title
    Cmax,ss (dose proportionality)
    Statistical analysis description
    Dose proportionality for Cmax,ss was explored.
    Comparison groups
    tamsulosin - low dose level (Steady State - PK study) v tamsulosin - medium dose level (Steady State - PK study) v tamsulosin - high dose level (Steady State - PK study)
    Number of subjects included in analysis
    29
    Analysis specification
    Pre-specified
    Analysis type
    other [63]
    Method
    Parameter type
    Slope
    Point estimate
    1.0039
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    0.6499
         upper limit
    1.3579
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.1725
    Notes
    [63] - Dose proportionality for Cmax,ss was explored based on the regression model. Based on the estimate for the slope parameter, a two sided 95% confidence interval for the slope was computed. Perfect dose proportionality would correspond to a slope of 1. Standard error of the mean is actually standard error of the slope.

    Secondary: Cmax,ss, DW, norm

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    End point title
    Cmax,ss, DW, norm
    End point description
    Dose- and weight-normalized for Cmax,ss, Cmax,ss, DW, norm. Weight normalization of Cmax,ss was performed by dividing the respective quantities by the reciprocal of body weight in kg. This Outcome Measure was only pre-specified for PK Study steady state group subjects, so results of this group is provided.
    End point type
    Secondary
    End point timeframe
    −0.25h prior to dose and 2h, 4h, 6h, 8h, 10h, 24h and 33h after the drug administration.
    End point values
    tamsulosin - low dose level (Steady State - PK study) tamsulosin - medium dose level (Steady State - PK study) tamsulosin - high dose level (Steady State - PK study)
    Number of subjects analysed
    10 [64]
    9 [65]
    10 [66]
    Units: ng/mL/mg*kg
        geometric mean (geometric coefficient of variation)
    2040 ± 74.3
    1850 ± 85.7
    2240 ± 47.6
    Notes
    [64] - Pharmacokinetics steady state set (PK-SS)
    [65] - Pharmacokinetics steady state set (PK-SS)
    [66] - Pharmacokinetics steady state set (PK-SS)
    No statistical analyses for this end point

    Secondary: Cmin,ss

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    End point title
    Cmin,ss
    End point description
    Minimum measured concentration of the analyte in plasma at steady state over a uniform dosing interval τ, Cmin,ss. This Outcome Measure was only pre-specified for PK Study- steady state group subjects, so results of this group is provided.
    End point type
    Secondary
    End point timeframe
    −0.25h prior to dose and 2h, 4h, 6h, 8h, 10h, 24h and 33h after the drug administration.
    End point values
    tamsulosin - low dose level (Steady State - PK study) tamsulosin - medium dose level (Steady State - PK study) tamsulosin - high dose level (Steady State - PK study)
    Number of subjects analysed
    10 [67]
    9 [68]
    10 [69]
    Units: ng/mL
        geometric mean (geometric coefficient of variation)
    0.747 ± 99.7
    1.52 ± 130
    4.01 ± 68.5
    Notes
    [67] - Pharmacokinetics steady state set (PK-SS)
    [68] - Pharmacokinetics steady state set (PK-SS)
    [69] - Pharmacokinetics steady state set (PK-SS)
    No statistical analyses for this end point

    Secondary: tmax,ss

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    End point title
    tmax,ss
    End point description
    Time from last dosing to maximum concentration of the analyte in plasma at steady state over a uniform dosing interval τ, tmax,ss. This Outcome Measure was only pre-specified for PK Study- steady state group subjects, so results of this group is provided.
    End point type
    Secondary
    End point timeframe
    −0.25h prior to dose and 2h, 4h, 6h, 8h, 10h, 24h and 33h after the drug administration.
    End point values
    tamsulosin - low dose level (Steady State - PK study) tamsulosin - medium dose level (Steady State - PK study) tamsulosin - high dose level (Steady State - PK study)
    Number of subjects analysed
    10 [70]
    9 [71]
    10 [72]
    Units: hours
        median (full range (min-max))
    5 (2.33 to 8)
    5.92 (2 to 8)
    5.01 (2.23 to 8)
    Notes
    [70] - Pharmacokinetics steady state set (PK-SS)
    [71] - Pharmacokinetics steady state set (PK-SS)
    [72] - Pharmacokinetics steady state set (PK-SS)
    No statistical analyses for this end point

    Secondary: AUCτ,ss

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    End point title
    AUCτ,ss
    End point description
    Area under the concentration-time curve of the analyte in plasma at steady state over a uniform dosing interval τ , AUCτ,ss. This Outcome Measure was only pre-specified for PK Study- steady state group subjects, so results of this group is provided.
    End point type
    Secondary
    End point timeframe
    −0.25h prior to dose and 2h, 4h, 6h, 8h, 10h, 24h and 33h after the drug administration.
    End point values
    tamsulosin - low dose level (Steady State - PK study) tamsulosin - medium dose level (Steady State - PK study) tamsulosin - high dose level (Steady State - PK study)
    Number of subjects analysed
    10 [73]
    9 [74]
    10 [75]
    Units: ng*h/mL
        geometric mean (geometric coefficient of variation)
    35.8 ± 75.6
    68.2 ± 94.7
    175 ± 61
    Notes
    [73] - Pharmacokinetics steady state set (PK-SS)
    [74] - Pharmacokinetics steady state set (PK-SS)
    [75] - Pharmacokinetics steady state set (PK-SS)
    Statistical analysis title
    AUCĪ„,ss (Dose proportionality)
    Statistical analysis description
    Dose proportionality for AUCτ,ss was explored.
    Comparison groups
    tamsulosin - medium dose level (Steady State - PK study) v tamsulosin - high dose level (Steady State - PK study) v tamsulosin - low dose level (Steady State - PK study)
    Number of subjects included in analysis
    29
    Analysis specification
    Pre-specified
    Analysis type
    other [76]
    Method
    Parameter type
    Slope
    Point estimate
    0.98
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    0.5934
         upper limit
    1.3666
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.1884
    Notes
    [76] - Dose proportionality for AUCτ,ss was explored based on the regression model. Based on the estimate for the slope parameter, a two sided 95% confidence interval for the slope was computed. Perfect dose proportionality would correspond to a slope of 1. Standard error of the mean is actually standard error of the slope.

    Secondary: AUCτ ,ss ,DW ,norm

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    End point title
    AUCτ ,ss ,DW ,norm
    End point description
    Dose- and weight-normalized of AUCτ ,ss ( AUCτ ,ss ,DW ,norm). Weight normalization of AUCτ,ss was performed by dividing the respective quantities by the reciprocal of body weight in kg. This Outcome Measure was only pre-specified for PK Study steady state group subjects, so results of this group is provided.
    End point type
    Secondary
    End point timeframe
    −0.25h prior to dose and 2h, 4h, 6h, 8h, 10h, 24h and 33h after the drug administration.
    End point values
    tamsulosin - low dose level (Steady State - PK study) tamsulosin - medium dose level (Steady State - PK study) tamsulosin - high dose level (Steady State - PK study)
    Number of subjects analysed
    10 [77]
    9 [78]
    10 [79]
    Units: ng*h/mL/mg*kg
        geometric mean (geometric coefficient of variation)
    26100 ± 91.1
    25200 ± 82.9
    27700 ± 59.1
    Notes
    [77] - Pharmacokinetics steady state set (PK-SS)
    [78] - Pharmacokinetics steady state set (PK-SS)
    [79] - Pharmacokinetics steady state set (PK-SS)
    No statistical analyses for this end point

    Secondary: λz,ss

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    End point title
    λz,ss
    End point description
    Terminal rate constant of the analyte in plasma at steady state, λz,ss. This Outcome Measure was only pre-specified for PK Study- steady state group subjects, so results of this group is provided.
    End point type
    Secondary
    End point timeframe
    −0.25h prior to dose and 2h, 4h, 6h, 8h, 10h, 24h and 33h after the drug administration.
    End point values
    tamsulosin - low dose level (Steady State - PK study) tamsulosin - medium dose level (Steady State - PK study) tamsulosin - high dose level (Steady State - PK study)
    Number of subjects analysed
    10 [80]
    9 [81]
    10 [82]
    Units: 1/hours
        geometric mean (geometric coefficient of variation)
    0.0589 ± 48.1
    0.0671 ± 40.8
    0.0496 ± 31.9
    Notes
    [80] - Pharmacokinetics steady state set (PK-SS)
    [81] - Pharmacokinetics steady state set (PK-SS)
    [82] - Pharmacokinetics steady state set (PK-SS)
    No statistical analyses for this end point

    Secondary: t1/2,ss

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    End point title
    t1/2,ss
    End point description
    Terminal half-life of the analyte in plasma at steady state, t1/2,ss. This Outcome Measure was only pre-specified for PK Study- steady state group subjects, so results of this group is provided.
    End point type
    Secondary
    End point timeframe
    −0.25h prior to dose and 2h, 4h, 6h, 8h, 10h, 24h and 33h after the drug administration.
    End point values
    tamsulosin - low dose level (Steady State - PK study) tamsulosin - medium dose level (Steady State - PK study) tamsulosin - high dose level (Steady State - PK study)
    Number of subjects analysed
    10 [83]
    9 [84]
    10 [85]
    Units: hours
        geometric mean (geometric coefficient of variation)
    11.8 ± 48.1
    10.3 ± 40.8
    14 ± 31.9
    Notes
    [83] - Pharmacokinetics steady state set (PK-SS)
    [84] - Pharmacokinetics steady state set (PK-SS)
    [85] - Pharmacokinetics steady state set (PK-SS)
    No statistical analyses for this end point

    Secondary: MRTpo,ss

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    End point title
    MRTpo,ss
    End point description
    Mean residence time of the analyte in the body at steady state after oral administration,MRTpo,ss. This Outcome Measure was only pre-specified for PK Study- steady state group subjects, so results of this group is provided.
    End point type
    Secondary
    End point timeframe
    −0.25h prior to dose and 2h, 4h, 6h, 8h, 10h, 24h and 33h after the drug administration.
    End point values
    tamsulosin - low dose level (Steady State - PK study) tamsulosin - medium dose level (Steady State - PK study) tamsulosin - high dose level (Steady State - PK study)
    Number of subjects analysed
    10 [86]
    9 [87]
    10 [88]
    Units: hours
        geometric mean (geometric coefficient of variation)
    18.7 ± 50.5
    17.6 ± 35
    20.9 ± 23.6
    Notes
    [86] - Pharmacokinetics steady state set (PK-SS)
    [87] - Pharmacokinetics steady state set (PK-SS)
    [88] - Pharmacokinetics steady state set (PK-SS)
    No statistical analyses for this end point

    Secondary: CL/F,ss,W,norm

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    End point title
    CL/F,ss,W,norm
    End point description
    Weight-normalized CL/F,ss (apparent clearance of the analyte in the plasma at steady state after extravascular multiple dose administration), CL/F,ss,W,norm. Weight-normalized CL/F,ss was calculated by dividing the respective quantities by body weight in kg. This Outcome Measure was only pre-specified for PK Study- steady state group subjects, so results of this group is provided.
    End point type
    Secondary
    End point timeframe
    −0.25h prior to dose and 2h, 4h, 6h, 8h, 10h, 24h and 33h after the drug administration.
    End point values
    tamsulosin - low dose level (Steady State - PK study) tamsulosin - medium dose level (Steady State - PK study) tamsulosin - high dose level (Steady State - PK study)
    Number of subjects analysed
    10 [89]
    9 [90]
    10 [91]
    Units: L/h/kg
        geometric mean (geometric coefficient of variation)
    0.0383 ± 91.1
    0.0397 ± 82.9
    0.0361 ± 59.1
    Notes
    [89] - Pharmacokinetics steady state set (PK-SS)
    [90] - Pharmacokinetics steady state set (PK-SS)
    [91] - Pharmacokinetics steady state set (PK-SS)
    No statistical analyses for this end point

    Secondary: Vz/F,ss,W,norm

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    End point title
    Vz/F,ss,W,norm
    End point description
    Weight-normalized Vz/F,ss (apparent volume of distribution during the terminal phase λz at steady state following extravascular administration), Vz/F,ss,W,norm. Weight-normalized VzF,ss was calculated by dividing the respective quantities by body weight in kg. This Outcome Measure was only pre-specified for PK Study- steady state group subjects, so results of this group is provided.
    End point type
    Secondary
    End point timeframe
    −0.25h prior to dose and 2h, 4h, 6h, 8h, 10h, 24h and 33h after the drug administration.
    End point values
    tamsulosin - low dose level (Steady State - PK study) tamsulosin - medium dose level (Steady State - PK study) tamsulosin - high dose level (Steady State - PK study)
    Number of subjects analysed
    10 [92]
    9 [93]
    10 [94]
    Units: L/kg
        geometric mean (geometric coefficient of variation)
    0.65 ± 83.8
    0.591 ± 103
    0.729 ± 96
    Notes
    [92] - Pharmacokinetics steady state set (PK-SS)
    [93] - Pharmacokinetics steady state set (PK-SS)
    [94] - Pharmacokinetics steady state set (PK-SS)
    No statistical analyses for this end point

    Secondary: RA,Cmax

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    End point title
    RA,Cmax
    End point description
    Accumulation ratios of tamsulosin HCl in plasma at steady state after multiple dose administration over a uniform dosing interval τ, expressed as ratio of Cmax at steady state and after single dose. The accumulation ratio RA,Cmax was calculated as : Cmax,ss/Cmax,1. This Outcome Measure was only pre-specified for PK Study- steady state group subjects, so results from this group is provided.
    End point type
    Secondary
    End point timeframe
    −0.25h prior to dose and 2h, 4h, 6h and 8h after the drug administration.
    End point values
    tamsulosin - low dose level (Steady State - PK study)
    Number of subjects analysed
    4 [95]
    Units: ng/mL
        geometric mean (geometric coefficient of variation)
    1.58 ± 65.2
    Notes
    [95] - Pharmacokinetics steady state set (PK-SS)
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    From first drug administration until 28 days after last study drug administration, upto 80 days (Steady State - PK study), upto 450 days (Group D-Denovo) and upto 395 days (Group D-527.51 Rollover).
    Adverse event reporting additional description
    Subjects were titrated to their efficacious dose.Based on LPP results,subjects could remain on that dose if it was found to be efficacious or titrate up to their higher doses which might have provided some efficacy.Therefore some of the subjects were counted more than once for having reported adverse events with different doses of the study.
    Assessment type
    Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    MedDRA
    Dictionary version
    11.1
    Reporting groups
    Reporting group title
    tamsulosin - low dose level (Steady State - PK study)
    Reporting group description
    Subjects randomized to low dose level (0.001–0.002 mg/kg) of tamsulosin hydrochloride, dependent on a subject's body weight. In PK study, all subjects were titrated to their randomized dose level that they needed to receive which was based on their weight. Depending on the results of the Leak point pressure (LPP) results, subjects could remain on that dose if it was found to be efficacious or go back to a lower efficacious dose or titrate up in hopes that the higher dose would provide some efficacy. Subjects with body weight of 12.1–25.0 kg received low dose of 0.025 mg qd (once daily), body weight of 25.1–50.0 kg received low dose of 0.05 mg qd and body weight of 50.1–100.0 kg received low dose of 0.1 mg qd by sprinkling the content of the capsule(s) over teaspoon of apple sauce or yogurt taken 30 minutes after breakfast.

    Reporting group title
    tamsulosin - medium dose level (Steady State - PK study)
    Reporting group description
    Subjects randomized to medium dose level (0.002–0.004 mg/kg) of tamsulosin hydrochloride, dependent on a subject's body weight. In PK study, all subjects were titrated to their randomized dose level that they needed to receive which was based on their weight. Depending on the results of the LPP results, subjects could remain on that dose if it was found to be efficacious or go back to a lower efficacious dose or titrate up in hopes that the higher dose would provide some efficacy. Subjects with body weight of 12.1–25.0 kg received medium dose of 0.05 mg qd, body weight of 25.1–50.0 kg received medium dose of 0.1 mg qd with and body weight of 50.1–100.0 kg received medium dose of 0.2 mg qd by sprinkling the content of the capsule(s) over teaspoon of apple sauce or yogurt, taken 30 minutes after breakfast.

    Reporting group title
    tamsulosin - high dose level (Steady State - PK study)
    Reporting group description
    Subjects randomized to high dose level(0.004-0.008mg/kg) of tamsulosin hydrochloride,dependent on a subject's body weight.In PK study,all subjects were titrated to their randomized dose level that they needed to receive which was based on their weight.Depending on the results of the LPP,subjects could remain on that dose if it was found to be efficacious or go back to a lower efficacious dose or titrate up in hopes that the higher dose would provide some efficacy.Subjects with body weight of 12.1-25.0kg received high dose of 0.1mg qd, body weight of 25.1-50.0kg received high dose of 0.2mg qd & body weight of 50.1-100.0kg received high dose of 0.4mg qd by sprinkling the content of the capsule(s) over teaspoon of apple sauce or yogurt taken 30 minutes after breakfast.One subject randomised to high dose level was not treated.Although actual number of subjects started is 11,10 were reported to ensure consistent reporting with baseline characteristics that includes only treated subjects.

    Reporting group title
    tamsulosin - low dose level (Group D-Denovo)
    Reporting group description
    Subjects received low dose level (0.001 – 0.002 mg/kg) of tamsulosin hydrochloride, dependent on a subject's body weight. In Group D-Denovo, all subjects started the study at the low Dose level, with the exception of the children with a body weight between 9 kg and 12 kg (they started at the Medium Dose level), and titrated up to higher dose levels on a weekly basis until an efficacious level was reached. The subjects remained on their efficacious dose level for the remainder of the study. Subjects with body weight of 12.1– 25.0 kg received low dose of 0.025 mg qd, body weight of 25.1–50.0 kg received low dose of 0.05 mg qd and body weight of 50.1–100.0 kg received low dose of 0.1 mg qd by sprinkling the content of the capsule(s) over teaspoon of apple sauce or yogurt taken 30 minutes after breakfast.

    Reporting group title
    tamsulosin - medium dose level (Group D-Denovo)
    Reporting group description
    Subjects who were titrated to medium dose level (0.002–0.004 mg/kg) of tamsulosin hydrochloride, dependent on a subject's body weight. In Group D-Denovo, all subjects started the study at the Low Dose level, with the exception of the children with a body weight between 9 kg and 12 kg (they started at the Medium Dose level), and titrated up to higher dose levels on a weekly basis until an efficacious level was reached. The subjectsremained on their efficacious dose level for the remainder of the study. Subjects with body weight of 9.0–12.0 kg received medium dose of 0.025 mg qd as their starting dose, body weight of 12.1-25.0 kg could have titrated to a medium dose of 0.05 mg qd, body weight of 25.1–50.0 kg could have titrated to a medium dose of 0.1 mg qd and body weight of 50.1–100.0 kg could have titrated to a medium dose of 0.2 mg qd by sprinkling the content of the capsule(s) over teaspoon of apple sauce or yogurt, taken 30 minutes after breakfast.

    Reporting group title
    tamsulosin - high dose level (Group D-Denovo)
    Reporting group description
    Subjects titrated to high dose level (0.004-0.008 mg/kg) of tamsulosin hydrochloride, once daily dependent on a subject's body weight. In Group D-Denovo, all subjects started the study at the Low Dose level, with the exception of the children with a body weight between 9 kg and 12 kg (they started at the Medium Dose level), and titrated up to higher dose levels on a weekly basis until an efficacious level was reached. The subjects remained on their efficacious dose level for the remainder of the study. Subjects with body weight of 9.0-12.0 kg received high dose of 0.05 mg qd, body weight of 12.1-25.0 kg received high dose of 0.1 mg qd, body weight of 25.1-50.0 kg received high dose of 0.2 mg qd & body weight of 50.1-100.0 kg received high dose of 0.4 mg qd by sprinkling the content of the capsule(s) over teaspoon of apple sauce or yogurt, taken 30 minutes after breakfast.

    Reporting group title
    tamsulosin - low dose level (Group D-527.51 Rollover)
    Reporting group description
    Subjects received low dose level (0.001–0.002 mg/kg) of tamsulosin hydrochloride, once daily dependent on a subject's body weight. In Group D- 527.51 Rollover, once subjects exited the double-blind trial they were rolled over into this trial (527.66). All subjects were to titrate to their efficacious dose. Doses that were available were based on subject's weight. Depending on the LPP results, subjects could remain on that dose if it was found to be efficacious or titrate up in hopes that that the higher doses would provide some efficacy. Subjects with body weight of 12.1-25.0 kg received low dose of 0.025 mg qd, body weight of 25.1-50.0 kg received low dose of 0.05 mg qd and body weight of 50.1-100.0 kg qd received low dose of 0.1 mg qd by sprinkling the content of the capsule(s) over teaspoon of apple sauce or yogurt, taken 30 minutes after breakfast.

    Reporting group title
    tamsulosin - medium dose level (Group D-527.51 Rollover)
    Reporting group description
    Subjects who were to receive medium dose level (0.002-0.004 mg/kg) of tamsulosin hydrochloride, once daily dependent on a subject's body weight. In Group D-527.51 Rollover, once subjects exited the double-blind trial they were rolled over into this trial. All subjects were to titrate to their efficacious dose. Doses that were available were based on subject's weight. Depending on the LPP results, subjects could remain on that dose if it was found to be efficacious or titrate up in hopes that the higher doses would provide some efficacy. Subjects with body weight of 12.1-25.0 kg received low dose of 0.05 mg qd, body weight of 25.1-50.0 kg received medium dose of 0.1 mg qd, body weight of 50.1-100.0 kg received medium dose of 0.2 mg qd by sprinkling the content of the capsule(s) over teaspoon of apple sauce or yogurt taken 30 minutes after breakfast.

    Reporting group title
    tamsulosin - high dose level (Group D-527.51 Rollover)
    Reporting group description
    Subjects titrated to high dose level (0.004-0.008 mg/kg) of tamsulosin hydrochloride, once daily dependent on a subject's body weight. In Group D-527.51 Rollover, once subjects exited the double-blind trial they were rolled over into this trial. All subjects had to titrate to their efficacious dose. Doses that were available were based on subject's weight. Depending on the LPP results, subjects could remain on that dose if it was found to be efficacious or titrate up in hopes that the higher doses would provide some efficacy. Subjects with body weight of 12.1-25.0 kg received high dose of 0.1 mg, body weight of 25.1-50.0 kg received high dose of 0.2 mg, body weight of 50.1-100.0 kg received high dose of 0.4 mg by sprinkling the content of the capsule(s) over teaspoon of apple sauce or yogurt taken 30 minutes after breakfast.

    Serious adverse events
    tamsulosin - low dose level (Steady State - PK study) tamsulosin - medium dose level (Steady State - PK study) tamsulosin - high dose level (Steady State - PK study) tamsulosin - low dose level (Group D-Denovo) tamsulosin - medium dose level (Group D-Denovo) tamsulosin - high dose level (Group D-Denovo) tamsulosin - low dose level (Group D-527.51 Rollover) tamsulosin - medium dose level (Group D-527.51 Rollover) tamsulosin - high dose level (Group D-527.51 Rollover)
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 10 (0.00%)
    1 / 10 (10.00%)
    0 / 10 (0.00%)
    2 / 82 (2.44%)
    3 / 61 (4.92%)
    4 / 41 (9.76%)
    1 / 93 (1.08%)
    1 / 41 (2.44%)
    1 / 29 (3.45%)
         number of deaths (all causes)
    0
    0
    0
    0
    0
    0
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Injury, poisoning and procedural complications
    Ventriculoperitoneal shunt malfunction
         subjects affected / exposed
    0 / 10 (0.00%)
    1 / 10 (10.00%)
    0 / 10 (0.00%)
    1 / 82 (1.22%)
    1 / 61 (1.64%)
    0 / 41 (0.00%)
    0 / 93 (0.00%)
    0 / 41 (0.00%)
    0 / 29 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Congenital, familial and genetic disorders
    Tibial torsion
         subjects affected / exposed
    0 / 10 (0.00%)
    0 / 10 (0.00%)
    0 / 10 (0.00%)
    0 / 82 (0.00%)
    0 / 61 (0.00%)
    1 / 41 (2.44%)
    0 / 93 (0.00%)
    0 / 41 (0.00%)
    0 / 29 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Asthma
         subjects affected / exposed
    0 / 10 (0.00%)
    0 / 10 (0.00%)
    0 / 10 (0.00%)
    0 / 82 (0.00%)
    1 / 61 (1.64%)
    0 / 41 (0.00%)
    0 / 93 (0.00%)
    0 / 41 (0.00%)
    0 / 29 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Nervous system disorders
    Tethered cord syndrome
         subjects affected / exposed
    0 / 10 (0.00%)
    0 / 10 (0.00%)
    0 / 10 (0.00%)
    0 / 82 (0.00%)
    0 / 61 (0.00%)
    1 / 41 (2.44%)
    0 / 93 (0.00%)
    0 / 41 (0.00%)
    0 / 29 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hydrocephalus
         subjects affected / exposed
    0 / 10 (0.00%)
    0 / 10 (0.00%)
    0 / 10 (0.00%)
    2 / 82 (2.44%)
    1 / 61 (1.64%)
    0 / 41 (0.00%)
    0 / 93 (0.00%)
    0 / 41 (0.00%)
    0 / 29 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 2
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Peritoneal cyst
         subjects affected / exposed
    0 / 10 (0.00%)
    0 / 10 (0.00%)
    0 / 10 (0.00%)
    1 / 82 (1.22%)
    0 / 61 (0.00%)
    0 / 41 (0.00%)
    0 / 93 (0.00%)
    0 / 41 (0.00%)
    0 / 29 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    Cellulitis
         subjects affected / exposed
    0 / 10 (0.00%)
    0 / 10 (0.00%)
    0 / 10 (0.00%)
    0 / 82 (0.00%)
    0 / 61 (0.00%)
    1 / 41 (2.44%)
    0 / 93 (0.00%)
    0 / 41 (0.00%)
    0 / 29 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Dengue fever
         subjects affected / exposed
    0 / 10 (0.00%)
    0 / 10 (0.00%)
    0 / 10 (0.00%)
    0 / 82 (0.00%)
    1 / 61 (1.64%)
    0 / 41 (0.00%)
    0 / 93 (0.00%)
    0 / 41 (0.00%)
    0 / 29 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastroenteritis
         subjects affected / exposed
    0 / 10 (0.00%)
    0 / 10 (0.00%)
    0 / 10 (0.00%)
    0 / 82 (0.00%)
    0 / 61 (0.00%)
    0 / 41 (0.00%)
    0 / 93 (0.00%)
    1 / 41 (2.44%)
    0 / 29 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Urinary tract infection
         subjects affected / exposed
    0 / 10 (0.00%)
    0 / 10 (0.00%)
    0 / 10 (0.00%)
    0 / 82 (0.00%)
    0 / 61 (0.00%)
    2 / 41 (4.88%)
    0 / 93 (0.00%)
    1 / 41 (2.44%)
    1 / 29 (3.45%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 2
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pneumonia
         subjects affected / exposed
    0 / 10 (0.00%)
    0 / 10 (0.00%)
    0 / 10 (0.00%)
    0 / 82 (0.00%)
    0 / 61 (0.00%)
    0 / 41 (0.00%)
    1 / 93 (1.08%)
    0 / 41 (0.00%)
    0 / 29 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    tamsulosin - low dose level (Steady State - PK study) tamsulosin - medium dose level (Steady State - PK study) tamsulosin - high dose level (Steady State - PK study) tamsulosin - low dose level (Group D-Denovo) tamsulosin - medium dose level (Group D-Denovo) tamsulosin - high dose level (Group D-Denovo) tamsulosin - low dose level (Group D-527.51 Rollover) tamsulosin - medium dose level (Group D-527.51 Rollover) tamsulosin - high dose level (Group D-527.51 Rollover)
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    5 / 10 (50.00%)
    5 / 10 (50.00%)
    3 / 10 (30.00%)
    51 / 82 (62.20%)
    25 / 61 (40.98%)
    33 / 41 (80.49%)
    31 / 93 (33.33%)
    10 / 41 (24.39%)
    9 / 29 (31.03%)
    Vascular disorders
    Orthostatic hypotension
         subjects affected / exposed
    1 / 10 (10.00%)
    1 / 10 (10.00%)
    0 / 10 (0.00%)
    1 / 82 (1.22%)
    2 / 61 (3.28%)
    1 / 41 (2.44%)
    0 / 93 (0.00%)
    0 / 41 (0.00%)
    0 / 29 (0.00%)
         occurrences all number
    1
    1
    0
    1
    2
    1
    0
    0
    0
    Investigations
    Body temperature increased
         subjects affected / exposed
    0 / 10 (0.00%)
    0 / 10 (0.00%)
    1 / 10 (10.00%)
    0 / 82 (0.00%)
    0 / 61 (0.00%)
    1 / 41 (2.44%)
    0 / 93 (0.00%)
    0 / 41 (0.00%)
    0 / 29 (0.00%)
         occurrences all number
    0
    2
    0
    0
    0
    1
    0
    0
    0
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    0 / 10 (0.00%)
    1 / 10 (10.00%)
    0 / 10 (0.00%)
    7 / 82 (8.54%)
    1 / 61 (1.64%)
    3 / 41 (7.32%)
    1 / 93 (1.08%)
    0 / 41 (0.00%)
    0 / 29 (0.00%)
         occurrences all number
    0
    1
    0
    8
    1
    4
    1
    0
    0
    Oropharyngeal pain
         subjects affected / exposed
    0 / 10 (0.00%)
    1 / 10 (10.00%)
    0 / 10 (0.00%)
    3 / 82 (3.66%)
    0 / 61 (0.00%)
    1 / 41 (2.44%)
    1 / 93 (1.08%)
    0 / 41 (0.00%)
    0 / 29 (0.00%)
         occurrences all number
    0
    1
    0
    3
    0
    1
    1
    0
    0
    Respiratory tract congestion
         subjects affected / exposed
    0 / 10 (0.00%)
    1 / 10 (10.00%)
    0 / 10 (0.00%)
    1 / 82 (1.22%)
    0 / 61 (0.00%)
    0 / 41 (0.00%)
    0 / 93 (0.00%)
    0 / 41 (0.00%)
    0 / 29 (0.00%)
         occurrences all number
    0
    1
    0
    1
    0
    0
    0
    0
    0
    Nervous system disorders
    Headache
         subjects affected / exposed
    0 / 10 (0.00%)
    1 / 10 (10.00%)
    0 / 10 (0.00%)
    8 / 82 (9.76%)
    2 / 61 (3.28%)
    3 / 41 (7.32%)
    2 / 93 (2.15%)
    1 / 41 (2.44%)
    2 / 29 (6.90%)
         occurrences all number
    0
    1
    0
    9
    4
    3
    2
    1
    2
    Dizziness
         subjects affected / exposed
    0 / 10 (0.00%)
    0 / 10 (0.00%)
    1 / 10 (10.00%)
    3 / 82 (3.66%)
    1 / 61 (1.64%)
    1 / 41 (2.44%)
    1 / 93 (1.08%)
    0 / 41 (0.00%)
    0 / 29 (0.00%)
         occurrences all number
    0
    0
    1
    3
    1
    1
    1
    0
    0
    General disorders and administration site conditions
    Pyrexia
         subjects affected / exposed
    2 / 10 (20.00%)
    0 / 10 (0.00%)
    0 / 10 (0.00%)
    12 / 82 (14.63%)
    3 / 61 (4.92%)
    6 / 41 (14.63%)
    1 / 93 (1.08%)
    1 / 41 (2.44%)
    1 / 29 (3.45%)
         occurrences all number
    2
    0
    0
    18
    4
    6
    1
    1
    1
    Mass
         subjects affected / exposed
    1 / 10 (10.00%)
    0 / 10 (0.00%)
    0 / 10 (0.00%)
    1 / 82 (1.22%)
    0 / 61 (0.00%)
    0 / 41 (0.00%)
    0 / 93 (0.00%)
    0 / 41 (0.00%)
    0 / 29 (0.00%)
         occurrences all number
    1
    0
    0
    1
    0
    0
    0
    0
    0
    Catheter related complication
         subjects affected / exposed
    1 / 10 (10.00%)
    0 / 10 (0.00%)
    0 / 10 (0.00%)
    0 / 82 (0.00%)
    0 / 61 (0.00%)
    0 / 41 (0.00%)
    0 / 93 (0.00%)
    0 / 41 (0.00%)
    0 / 29 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    0
    0
    0
    Suprapubic pain
         subjects affected / exposed
    1 / 10 (10.00%)
    0 / 10 (0.00%)
    0 / 10 (0.00%)
    0 / 82 (0.00%)
    0 / 61 (0.00%)
    0 / 41 (0.00%)
    0 / 93 (0.00%)
    0 / 41 (0.00%)
    0 / 29 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    0
    0
    0
    Psychiatric disorders
    Nervousness
         subjects affected / exposed
    1 / 10 (10.00%)
    0 / 10 (0.00%)
    0 / 10 (0.00%)
    0 / 82 (0.00%)
    1 / 61 (1.64%)
    0 / 41 (0.00%)
    0 / 93 (0.00%)
    0 / 41 (0.00%)
    0 / 29 (0.00%)
         occurrences all number
    1
    0
    0
    0
    1
    0
    0
    0
    0
    Gastrointestinal disorders
    Abdominal pain
         subjects affected / exposed
    0 / 10 (0.00%)
    0 / 10 (0.00%)
    1 / 10 (10.00%)
    4 / 82 (4.88%)
    0 / 61 (0.00%)
    1 / 41 (2.44%)
    2 / 93 (2.15%)
    0 / 41 (0.00%)
    1 / 29 (3.45%)
         occurrences all number
    0
    0
    1
    4
    0
    1
    2
    0
    1
    Abdominal pain upper
         subjects affected / exposed
    1 / 10 (10.00%)
    0 / 10 (0.00%)
    0 / 10 (0.00%)
    3 / 82 (3.66%)
    1 / 61 (1.64%)
    1 / 41 (2.44%)
    2 / 93 (2.15%)
    0 / 41 (0.00%)
    0 / 29 (0.00%)
         occurrences all number
    1
    0
    0
    3
    1
    1
    2
    0
    0
    Diarrhoea
         subjects affected / exposed
    0 / 10 (0.00%)
    0 / 10 (0.00%)
    1 / 10 (10.00%)
    4 / 82 (4.88%)
    2 / 61 (3.28%)
    2 / 41 (4.88%)
    1 / 93 (1.08%)
    2 / 41 (4.88%)
    0 / 29 (0.00%)
         occurrences all number
    0
    0
    1
    5
    2
    2
    2
    2
    0
    Vomiting
         subjects affected / exposed
    1 / 10 (10.00%)
    1 / 10 (10.00%)
    1 / 10 (10.00%)
    9 / 82 (10.98%)
    4 / 61 (6.56%)
    3 / 41 (7.32%)
    3 / 93 (3.23%)
    2 / 41 (4.88%)
    0 / 29 (0.00%)
         occurrences all number
    1
    1
    1
    9
    10
    4
    4
    2
    0
    Renal and urinary disorders
    Hydronephrosis
         subjects affected / exposed
    0 / 10 (0.00%)
    0 / 10 (0.00%)
    0 / 10 (0.00%)
    2 / 82 (2.44%)
    1 / 61 (1.64%)
    3 / 41 (7.32%)
    0 / 93 (0.00%)
    0 / 41 (0.00%)
    0 / 29 (0.00%)
         occurrences all number
    0
    0
    0
    2
    1
    3
    0
    0
    0
    Skin and subcutaneous tissue disorders
    Rash
         subjects affected / exposed
    0 / 10 (0.00%)
    2 / 10 (20.00%)
    0 / 10 (0.00%)
    1 / 82 (1.22%)
    2 / 61 (3.28%)
    0 / 41 (0.00%)
    0 / 93 (0.00%)
    1 / 41 (2.44%)
    0 / 29 (0.00%)
         occurrences all number
    0
    3
    0
    1
    2
    0
    0
    1
    0
    Infections and infestations
    Cervicitis
         subjects affected / exposed
    0 / 10 (0.00%)
    0 / 10 (0.00%)
    0 / 10 (0.00%)
    1 / 82 (1.22%)
    0 / 61 (0.00%)
    3 / 41 (7.32%)
    0 / 93 (0.00%)
    0 / 41 (0.00%)
    0 / 29 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    4
    0
    0
    0
    Nasopharyngitis
         subjects affected / exposed
    0 / 10 (0.00%)
    1 / 10 (10.00%)
    0 / 10 (0.00%)
    4 / 82 (4.88%)
    3 / 61 (4.92%)
    1 / 41 (2.44%)
    5 / 93 (5.38%)
    1 / 41 (2.44%)
    2 / 29 (6.90%)
         occurrences all number
    0
    1
    0
    4
    3
    1
    6
    1
    3
    Influenza
         subjects affected / exposed
    0 / 10 (0.00%)
    0 / 10 (0.00%)
    0 / 10 (0.00%)
    3 / 82 (3.66%)
    1 / 61 (1.64%)
    1 / 41 (2.44%)
    5 / 93 (5.38%)
    0 / 41 (0.00%)
    0 / 29 (0.00%)
         occurrences all number
    0
    0
    0
    4
    1
    1
    6
    0
    0
    Pharyngitis
         subjects affected / exposed
    0 / 10 (0.00%)
    0 / 10 (0.00%)
    0 / 10 (0.00%)
    11 / 82 (13.41%)
    1 / 61 (1.64%)
    2 / 41 (4.88%)
    2 / 93 (2.15%)
    1 / 41 (2.44%)
    1 / 29 (3.45%)
         occurrences all number
    0
    0
    0
    12
    1
    2
    2
    1
    1
    Upper respiratory tract infection
         subjects affected / exposed
    0 / 10 (0.00%)
    1 / 10 (10.00%)
    0 / 10 (0.00%)
    1 / 82 (1.22%)
    1 / 61 (1.64%)
    3 / 41 (7.32%)
    1 / 93 (1.08%)
    1 / 41 (2.44%)
    0 / 29 (0.00%)
         occurrences all number
    0
    1
    0
    1
    1
    4
    1
    1
    0
    Urinary tract infection
         subjects affected / exposed
    2 / 10 (20.00%)
    1 / 10 (10.00%)
    1 / 10 (10.00%)
    15 / 82 (18.29%)
    11 / 61 (18.03%)
    16 / 41 (39.02%)
    9 / 93 (9.68%)
    3 / 41 (7.32%)
    4 / 29 (13.79%)
         occurrences all number
    2
    1
    1
    18
    16
    23
    16
    6
    4

    More information

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    Substantial protocol amendments (globally)

    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    23 Jan 2006
    1) Inclusion criteria changed to include patients up to 16 years of age (previously 15 years of age maximum) 2) Terminology “end of study” was used incorrectly and changed to “end of treatment” where applicable. 3) Additional safety monitoring was implemented, including additional ECG (Visit 9), urinalysis, and recording of post-void residual for specific visits. 4) Study population was further described as “patient with elevated detrusor leak point pressure associated with a known neurological disorder (e.g., spina bifida)”. 5) Hormonal assays were added at Visit 9 for Group D-Rollover patients.
    23 Oct 2006
    1) After first 11 patients provided first-dose PK samples, first-dose PK sampling was made optional for all future patients 2) Due to altered PK sampling on Day 1 (Visit 2), vital sign testing and orthostatic testing were decreased. 3) The detrusor leak point pressure eligibility requirements were clarified 4) The addition of recent Botox injections used for urological disease management was added as an exclusion criterion. 5) Yogurt was added as an alternative drug administration vehicle, the amount of vehicle was specified, and the need to take a spoonful of water after administration of the drug was added. 6) The study drug storage conditions were further clarified

    Interruptions (globally)

    Were there any global interruptions to the trial? Yes
    Date
    Interruption
    Restart date
    30 Jun 2009
    The Group D-Rollover portion of Study 527.66 was terminated early based on data from placebo-controlled Study 527.51 that showed lack of efficacy in reducing LPP to <40 cm H2O. Reductions in detrusor LPP were observed for some patients during the study.
    -

    Limitations and caveats

    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    In Group D-527.51 Rollover study, due to the early termination caution should be used in interpreting these results due to the impact of the early termination, as well as the impact of the study design on interpretation of results by dose.
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