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    Clinical Trial Results:
    A Phase 3b, Multicenter, Extension Follow-up Trial to Evaluate the Long-term Safety of Children and Adolescent Subjects With Euvolemic or Hypervolemic Hyponatremia Who Have Previously Participated in a Trial of Titrated Oral SAMSCA® (Tolvaptan)

    Summary
    EudraCT number
    2013-002810-11
    Trial protocol
    DE   GB   BE   IT   CZ   RO   ES  
    Global end of trial date
    23 Oct 2017

    Results information
    Results version number
    v1(current)
    This version publication date
    17 Sep 2021
    First version publication date
    17 Sep 2021
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    156-11-294
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    NCT02020278
    WHO universal trial number (UTN)
    -
    Sponsors
    Sponsor organisation name
    Otsuka Pharmaceutical Development & Commercialization, Inc
    Sponsor organisation address
    2440 Research Boulevard, Rockville, MD, United States, 20850
    Public contact
    Otsuka Pharmaceutical Development & Commercialization, Inc., Global Clinical Development, +1 844-687-8522, OtsukaRMReconciliation@rmpdc.org
    Scientific contact
    Otsuka Pharmaceutical Development & Commercialization, Inc., Global Clinical Development, +1 844-687-8522, OtsukaRMReconciliation@rmpdc.org
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    Yes
    EMA paediatric investigation plan number(s)
    EMEA-001231-PIP02-13
    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?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    23 Oct 2017
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    23 Oct 2017
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main objective of the trial
    The objective of this trial was to provide 6 months of safety follow-up for children and adolescents with dilutional (euvolemic or hypervolemic) hyponatremia who had previously participated in a tolvaptan hyponatremia trial and to assess the efficacy of tolvaptan in increasing serum sodium for those participants who received optional continuing tolvaptan treatment of variable duration (up to 6 months).
    Protection of trial subjects
    This trial was conducted in compliance with Good Clinical Practice guidelines for conducting, recording, and reporting trials, as well as for archiving essential documents. Consistent with ethical principles for the protection of human research subjects, no trial procedures were performed on trial candidates until written consent had been obtained from them. The informed consent form, protocol, and amendments for this trial were submitted to and approved by the institutional review board or ethics committee at each respective trial center.
    Background therapy
    -
    Evidence for comparator
    -
    Actual start date of recruitment
    22 Apr 2016
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    United States: 3
    Worldwide total number of subjects
    3
    EEA total number of subjects
    0
    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)
    1
    Children (2-11 years)
    1
    Adolescents (12-17 years)
    1
    Adults (18-64 years)
    0
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    Eligible participants included those enrolled in a previous tolvaptan pediatric trial for hyponatremia (NCT02012959); who provided written informed consent at baseline and were able to understand that he/she could withdraw at any time; with the ability to comply with all requirements of the trial; ready to be followed up for 6 months.

    Pre-assignment
    Screening details
    There was no screening phase. Approximately 100 male or female participants were planned to be enrolled in this trial. A total of 3 participants were enrolled in this trial, but no participant received optional investigational medicinal product during this trial.

    Period 1
    Period 1 title
    Overall trial (overall period)
    Is this the baseline period?
    Yes
    Allocation method
    Non-randomised - controlled
    Blinding used
    Not blinded

    Arms
    Arm title
    Tolvaptan
    Arm description
    All participants enrolled first entered a 6-month follow-up trial that evaluated post-treatment safety after participation in a tolvaptan hyponatremia trial. Participants were then eligible to receive open-label tolvaptan if they had a clinical need as determined by the investigator and met the eligibility criteria for optional tolvaptan treatment during the 6-month follow-up period. In this trial, no participants qualified for treatment during the 6- month follow-up period. Daily dose levels would have included 3.75 milligrams (mg), 7.5 mg, 15 mg, 30 mg, and 60 mg. However, no subjects received IMP during this trial.
    Arm type
    Experimental

    Investigational medicinal product name
    Tolvaptan
    Investigational medicinal product code
    Other name
    SAMSCA®
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Tolvaptan was planned to be supplied as 3.75-, 7.5-, 15-, and 30 mg spray-dried tablets and administered orally once daily (QD), preferably in the morning hours, with a dose-proportional amount of water. However, no subjects received IMP during this trial.

    Number of subjects in period 1
    Tolvaptan
    Started
    3
    Completed
    3

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Overall trial
    Reporting group description
    -

    Reporting group values
    Overall trial Total
    Number of subjects
    3 3
    Age categorical
    Due to the low number of participants enrolled, 0 participants are reported due to the risk of re-identification.
    Units: Subjects
        Not recorded
    3 3
    Gender categorical
    Due to the low number of participants enrolled, 0 participants are reported due to the risk of re-identification.
    Units: Subjects
        Not recorded
    3 3

    End points

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    End points reporting groups
    Reporting group title
    Tolvaptan
    Reporting group description
    All participants enrolled first entered a 6-month follow-up trial that evaluated post-treatment safety after participation in a tolvaptan hyponatremia trial. Participants were then eligible to receive open-label tolvaptan if they had a clinical need as determined by the investigator and met the eligibility criteria for optional tolvaptan treatment during the 6-month follow-up period. In this trial, no participants qualified for treatment during the 6- month follow-up period. Daily dose levels would have included 3.75 milligrams (mg), 7.5 mg, 15 mg, 30 mg, and 60 mg. However, no subjects received IMP during this trial.

    Primary: Change From Baseline At Month 6 In Serum Sodium While Tolvaptan Was Being Administered

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    End point title
    Change From Baseline At Month 6 In Serum Sodium While Tolvaptan Was Being Administered [1]
    End point description
    No enrolled participant received any investigational medicinal product during the study. Due to early study termination, efficacy data were not collected for this outcome measure.
    End point type
    Primary
    End point timeframe
    Baseline, Month 6
    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: Due to early study termination, efficacy data were not collected.
    End point values
    Tolvaptan
    Number of subjects analysed
    0 [2]
    Units: number
        number (not applicable)
    Notes
    [2] - Due to early study termination, efficacy data were not collected for this outcome measure.
    No statistical analyses for this end point

    Secondary: Percentage Of Participants Who Required Rescue Therapy While On Tolvaptan Treatment

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    End point title
    Percentage Of Participants Who Required Rescue Therapy While On Tolvaptan Treatment
    End point description
    No enrolled participant received any investigational medicinal product during the study. Due to early study termination, efficacy data were not collected for this outcome measure.
    End point type
    Secondary
    End point timeframe
    Month 6
    End point values
    Tolvaptan
    Number of subjects analysed
    0 [3]
    Units: number
        number (not applicable)
    Notes
    [3] - Due to early study termination, efficacy data were not collected.
    No statistical analyses for this end point

    Secondary: Percentage Of Participants Who Had Recurrence Of Hyponatremia While On Tolvaptan

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    End point title
    Percentage Of Participants Who Had Recurrence Of Hyponatremia While On Tolvaptan
    End point description
    No enrolled participant received any investigational medicinal product during the study. Due to early study termination, efficacy data were not collected for this outcome measure.
    End point type
    Secondary
    End point timeframe
    Month 6
    End point values
    Tolvaptan
    Number of subjects analysed
    0 [4]
    Units: number
        number (not applicable)
    Notes
    [4] - Due to early study termination, efficacy data were not collected.
    No statistical analyses for this end point

    Secondary: Percentage Of Participants Requiring Continuation Of Tolvaptan Following 30 Days Of Treatment

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    End point title
    Percentage Of Participants Requiring Continuation Of Tolvaptan Following 30 Days Of Treatment
    End point description
    No enrolled participant received any investigational medicinal product during the study. Due to early study termination, efficacy data were not collected for this outcome measure.
    End point type
    Secondary
    End point timeframe
    Month 6
    End point values
    Tolvaptan
    Number of subjects analysed
    0 [5]
    Units: number
        number (not applicable)
    Notes
    [5] - Due to early study termination, efficacy data were not collected.
    No statistical analyses for this end point

    Secondary: Change From Baseline In Pediatric Quality of Life Inventory (PedsQL) Generic Core Scale (GCS) Total Score At Month 6

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    End point title
    Change From Baseline In Pediatric Quality of Life Inventory (PedsQL) Generic Core Scale (GCS) Total Score At Month 6
    End point description
    The PedsQL GCS was used for quality of life assessment. It is appropriate for at least 2 years of age, however availability may be limited for certain ages and languages. It encompasses 4 dimensions of functioning (physical, emotional, social, school). The age groups covered are: Toddler (2-4 years), Young child (5-7 years), Child (8-12 years), and Adolescent (13-18 years). Depending on the participant's age, the questionnaire may be completed by either the participant or the parent/caregiver, as appropriate. For the Toddler group, the PedsQL GCS consists of 21 items, using a 5-point Likert scale (0 to 4); for all other groups, the PedsQL GCS consists of 23 items, with a 3-point Likert scale (0, 2, 4) for the Young Child, and a 5-point Likert scale for the Child and Adolescent groups. Scores are transformed on a scale from 0 to 100 and averaged. Higher scores indicate improved quality of life. The change from baseline in the GCS total score is presented.
    End point type
    Secondary
    End point timeframe
    Baseline, Month 6
    End point values
    Tolvaptan
    Number of subjects analysed
    1 [6]
    Units: units on a scale
        arithmetic mean (full range (min-max))
    -3.5 (-3.5 to -3.5)
    Notes
    [6] - All enrolled participants with analyzable data at specified timepoint.
    No statistical analyses for this end point

    Secondary: Change From Baseline In PedsQL GCS Physical Health Summary Score At Month 6

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    End point title
    Change From Baseline In PedsQL GCS Physical Health Summary Score At Month 6
    End point description
    The PedsQL GCS was used for quality of life assessment. It is appropriate for at least 2 years of age, however availability may be limited for certain ages and languages. It encompasses 4 dimensions of functioning (physical, emotional, social, school). The age groups covered are: Toddler (2-4 years), Young child (5-7 years), Child (8-12 years), and Adolescent (13-18 years). Depending on the participant's age, the questionnaire may be completed by either the participant or the parent/caregiver, as appropriate. For the Toddler group, the PedsQL GCS consists of 21 items, using a 5-point Likert scale (0 to 4); for all other groups, the PedsQL GCS consists of 23 items, with a 3-point Likert scale (0, 2, 4) for the Young Child, and a 5-point Likert scale for the Child and Adolescent groups. Scores are transformed on a scale from 0 to 100 and averaged. Higher scores indicate improved quality of life. The change from baseline in the physical health dimension is presented.
    End point type
    Secondary
    End point timeframe
    Baseline, Month 6
    End point values
    Tolvaptan
    Number of subjects analysed
    1 [7]
    Units: units on a scale
        arithmetic mean (full range (min-max))
    12.5 (12.5 to 12.5)
    Notes
    [7] - All enrolled participants with analyzable data at specified timepoint.
    No statistical analyses for this end point

    Secondary: Change From Baseline In PedsQL GCS Psychosocial Health Summary Score At Month 6

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    End point title
    Change From Baseline In PedsQL GCS Psychosocial Health Summary Score At Month 6
    End point description
    The PedsQL GCS was used for quality of life assessment. It is appropriate for at least 2 years of age, however availability may be limited for certain ages and languages. It encompasses 4 dimensions of functioning (physical, emotional, social, school). The age groups covered are: Toddler (2-4 years), Young child (5-7 years), Child (8-12 years), and Adolescent (13-18 years). Depending on the participant's age, the questionnaire may be completed by either the participant or the parent/caregiver, as appropriate. For the Toddler group, the PedsQL GCS consists of 21 items, using a 5-point Likert scale (0 to 4); for all other groups, the PedsQL GCS consists of 23 items, with a 3-point Likert scale (0, 2, 4) for the Young Child, and a 5-point Likert scale for the Child and Adolescent groups. Scores are transformed on a scale from 0 to 100 and averaged. Higher scores indicate improved quality of life. The change from baseline in summed emotional, social, and school dimensions is presented.
    End point type
    Secondary
    End point timeframe
    Baseline, Month 6
    End point values
    Tolvaptan
    Number of subjects analysed
    1 [8]
    Units: units on a scale
        arithmetic mean (full range (min-max))
    -13.5 (-13.5 to -13.5)
    Notes
    [8] - All enrolled participants with analyzable data at specified timepoint.
    No statistical analyses for this end point

    Secondary: Change From Baseline In PedsQL Multidimensional Fatigue Scale (MFS) Total Score At Month 6

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    End point title
    Change From Baseline In PedsQL Multidimensional Fatigue Scale (MFS) Total Score At Month 6
    End point description
    The PedsQL MFS was used for quality-of-life assessment. It is appropriate for at least 2 years of age; however, availability may be limited for certain ages and languages. The PedsQL MFS consists of 18 items in 3 subscales: general fatigue, sleep/rest fatigue, and cognitive fatigue. The instrument focuses on the domains of processing speed, attention/vigilance, visual and working memory. The age groups covered by these assessments are Toddler (2–4 years), Young child (5–7 years), Child (8–12 years), and Adolescent (13–18 years). Depending on the subject’s age, the questionnaire may be completed by either the subject or the parent/caregiver, as appropriate. A 5-point Likert scale is used (0 = never a problem; 1 = almost never a problem; 2 = sometimes a problem; 3 = often a problem; 4 = almost always a problem). Items are reverse-scored and transformed to a 0–100 scale so that higher PedsQL MFS scores indicate better quality of life.
    End point type
    Secondary
    End point timeframe
    Baseline, Month 6
    End point values
    Tolvaptan
    Number of subjects analysed
    1 [9]
    Units: units on a scale
        arithmetic mean (full range (min-max))
    9.7 (9.7 to 9.7)
    Notes
    [9] - All enrolled participants with analyzable data at specified timepoint.
    No statistical analyses for this end point

    Secondary: Percentage Of Participants With Overly Rapid Correction In Serum Sodium 24 Hours After The First Dose At Introduction Or Reintroduction Of Tolvaptan

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    End point title
    Percentage Of Participants With Overly Rapid Correction In Serum Sodium 24 Hours After The First Dose At Introduction Or Reintroduction Of Tolvaptan
    End point description
    End point type
    Secondary
    End point timeframe
    Month 6
    End point values
    Tolvaptan
    Number of subjects analysed
    0 [10]
    Units: number
        number (not applicable)
    Notes
    [10] - Due to early study termination, efficacy data were not collected.
    No statistical analyses for this end point

    Secondary: Plasma Concentrations Of Tolvaptan And Metabolites In Participants Who Had Continued Tolvaptan Therapy For Eight Consecutive Weeks

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    End point title
    Plasma Concentrations Of Tolvaptan And Metabolites In Participants Who Had Continued Tolvaptan Therapy For Eight Consecutive Weeks
    End point description
    End point type
    Secondary
    End point timeframe
    8 Weeks
    End point values
    Tolvaptan
    Number of subjects analysed
    0 [11]
    Units: number
        number (not applicable)
    Notes
    [11] - Due to early study termination, no pharmacokinetic analyses were performed.
    No statistical analyses for this end point

    Secondary: Participants With A Tanner Staging Score Of 1 At Month 6

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    End point title
    Participants With A Tanner Staging Score Of 1 At Month 6
    End point description
    Tanner Staging assessment consists of 2 domains (pubic hair and breast development) for girls and 3 domains (pubic hair, penis development, and testes development) for boys. Staging was based on a single score summarizing the domains (not individual domain scores). Stages range from 1-5, with 1 indicating preadolescent and 5 adult. Participants with a Tanner staging score of 1 (preadolescent) at Month 6 are reported.
    End point type
    Secondary
    End point timeframe
    Month 6
    End point values
    Tolvaptan
    Number of subjects analysed
    3 [12]
    Units: Count of Participants
        number (not applicable)
    2
    Notes
    [12] - All enrolled participants with analyzable data at specified timepoint.
    No statistical analyses for this end point

    Secondary: Change From Baseline In Growth Percentiles For Body Height And Weight At Month 6

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    End point title
    Change From Baseline In Growth Percentiles For Body Height And Weight At Month 6
    End point description
    Changes from baseline in growth percentiles for body height and weight were calculated and are reported.
    End point type
    Secondary
    End point timeframe
    Baseline, Month 6
    End point values
    Tolvaptan
    Number of subjects analysed
    3 [13]
    Units: percentile
    arithmetic mean (standard deviation)
        Height Percentile
    19.0 ± 40.0
        Weight Percentile
    0.7 ± 8.0
    Notes
    [13] - All enrolled participants with analyzable data at specified timepoint.
    No statistical analyses for this end point

    Secondary: Change From Baseline In Alanine Aminotransferase (ALT) And Aspartate Aminotransferase (AST) For Participants On Tolvaptan At Month 2

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    End point title
    Change From Baseline In Alanine Aminotransferase (ALT) And Aspartate Aminotransferase (AST) For Participants On Tolvaptan At Month 2
    End point description
    No enrolled participant received any investigational medicinal product during the study. Due to early study termination, efficacy data were not collected. Data reported only include assessments made for ALT and AST during the Core Safety Follow-up Component of the trial. Results are reported in units/liter (U/L).
    End point type
    Secondary
    End point timeframe
    Baseline, Month 2
    End point values
    Tolvaptan
    Number of subjects analysed
    2 [14]
    Units: U/L
    arithmetic mean (standard deviation)
        ALT
    -10.00 ± 45.25
        AST
    -7.50 ± 0.71
    Notes
    [14] - All enrolled participants with analyzable data at specified timepoint.
    No statistical analyses for this end point

    Secondary: Change From Baseline In Bilirubin For Participants On Tolvaptan At Month 2

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    End point title
    Change From Baseline In Bilirubin For Participants On Tolvaptan At Month 2
    End point description
    No enrolled participant received any investigational medicinal product during the study. Due to early study termination, efficacy data were not collected. Data reported only include assessments made for bilirubin during the Core Safety Follow-up Component of the trial. Results are reported in micromoles (umol)/L.
    End point type
    Secondary
    End point timeframe
    Baseline, Month 2
    End point values
    Tolvaptan
    Number of subjects analysed
    2 [15]
    Units: umol/L
        arithmetic mean (standard deviation)
    2.57 ± 3.63
    Notes
    [15] - All enrolled participants with analyzable data at specified timepoint.
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Baseline to Month 6
    Assessment type
    Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    MedDRA
    Dictionary version
    19.0
    Reporting groups
    Reporting group title
    Tolvaptan
    Reporting group description
    All participants enrolled first entered a 6-month follow-up trial that evaluated post-treatment safety after participation in a tolvaptan hyponatremia trial. Participants were then eligible to receive open-label tolvaptan if they had a clinical need as determined by the investigator and met the eligibility criteria for optional tolvaptan treatment during the 6-month follow-up period. In this trial, no participants qualified for treatment during the 6-month follow-up period. Daily dose levels would have included 3.75 milligrams (mg), 7.5 mg, 15 mg, 30 mg, and 60 mg.

    Serious adverse events
    Tolvaptan
    Total subjects affected by serious adverse events
         subjects affected / exposed
    1 / 3 (33.33%)
         number of deaths (all causes)
    0
         number of deaths resulting from adverse events
    0
    General disorders and administration site conditions
    Pyrexia
         subjects affected / exposed
    1 / 3 (33.33%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Infections and infestations
    Enterovirus Infection
         subjects affected / exposed
    1 / 3 (33.33%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Rhinovirus Infection
         subjects affected / exposed
    1 / 3 (33.33%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Urosepsis
         subjects affected / exposed
    1 / 3 (33.33%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    Tolvaptan
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    2 / 3 (66.67%)
    General disorders and administration site conditions
    Pyrexia
         subjects affected / exposed
    1 / 3 (33.33%)
         occurrences all number
    1
    Infections and infestations
    Bronchitis
         subjects affected / exposed
    1 / 3 (33.33%)
         occurrences all number
    1
    Enterovirus Infection
         subjects affected / exposed
    1 / 3 (33.33%)
         occurrences all number
    1
    Rhinovirus Infection
         subjects affected / exposed
    1 / 3 (33.33%)
         occurrences all number
    1
    Urosepsis
         subjects affected / exposed
    1 / 3 (33.33%)
         occurrences all number
    1
    Viral Upper Respiratory Tract Infection
         subjects affected / exposed
    1 / 3 (33.33%)
         occurrences all number
    1

    More information

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    Substantial protocol amendments (globally)

    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    05 Sep 2013
    • To increase the consistency of this protocol with other tolvaptan pediatric hyponatremia protocols • To revise trial endpoints in accordance with the Pediatric Investigation Plan • To clarify study design, procedures, and assessments • To incorporate revised definitions of IMP causality
    26 Feb 2015
    • Implementation of additional serum sodium testing during drug titration to align with the current EU label (SmPC) for the adult indication of hyponatremia. We are adding safety testing for serum sodium at interim time points during titration with the option of using a point of care device to minimize impact on total blood volume required for the trial. • Additional background data from non-clinical juvenile toxicity studies. • Updates to clarify prohibition of hypertonic saline. • Clarify roll-over into extension study 156-11-294. • Clarification of scheduled treatment interruption after 30 days of treatment and close clinical monitoring with the addition of visits.
    09 Nov 2015
    The main intent of the amendment is to streamline text within the protocol by providing administrative clarifications, removing duplicative language, and ensuring consistency across sections. Efficiencies have been established in the Schedule of Assessments between the core safety and optional tolvaptan treatment components. This amendment is also intended to reduce burden on the subject, including the replacement of Months 2 and 4 in-clinic visits with telephone assessments. Therefore assessments required for in clinic visits on these months have been removed.

    Interruptions (globally)

    Were there any global interruptions to the trial? Yes
    Date
    Interruption
    Restart date
    23 Oct 2017
    Terminated. Issues with recruitment and enrollment made the trial impossible or highly impracticable. Termination of this trial was not due to safety reasons.
    -

    Limitations and caveats

    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    None reported
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