Flag of the European Union EU Clinical Trials Register Help

Clinical trials

The European Union Clinical Trials Register allows you to search for protocol and results information on:
  • interventional clinical trials that are conducted in the European Union (EU) and the European Economic Area (EEA);
  • clinical trials conducted outside the EU / EEA that are linked to European paediatric-medicine development.
  • Learn   more about the EU Clinical Trials Register   including the source of the information and the legal basis.


    The EU Clinical Trials Register currently displays   41225   clinical trials with a EudraCT protocol, of which   6755   are clinical trials conducted with subjects less than 18 years old.
    The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).


    Phase 1 trials conducted solely in adults and that are not part of an agreed PIP are not public in the EU CTR (refer to European Guidance 2008/C 168/02   Art. 3 par. 2 and   Commission Guideline 2012/C 302/03,   Art. 5) .
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools
     

    < Back to search results

    Download PDF

    Clinical Trial Results:
    A Comparative, Randomized, Single-Dose, 2-Way Crossover Bioavailability Study of a Compounded 4 mg/mL Olmesartan Medoxomil Suspension (Total Dose 40 mg) and 40 mg Olmesartan Medoxomil Tablets (Benicar®) in Healthy Adult Volunteers Under Fasting Conditions

    Summary
    EudraCT number
    2015-003005-41
    Trial protocol
    Outside EU/EEA  
    Global end of trial date
    13 Dec 2004

    Results information
    Results version number
    v1(current)
    This version publication date
    20 Nov 2018
    First version publication date
    02 Sep 2016
    Other versions

    Trial information

    Close Top of page
    Trial identification
    Sponsor protocol code
    CS0866-A-U101
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    -
    WHO universal trial number (UTN)
    -
    Sponsors
    Sponsor organisation name
    Sankyo Pharma Development
    Sponsor organisation address
    399 Thornall Street, Edison, United States, NJ 08837
    Public contact
    Daiichi Sankyo Pharma Development, 399 Thornall Street, Edison, NJ 08837, United States, Jason Mann, +001 732 5905011, jamann@dsi.com
    Scientific contact
    Daiichi Sankyo Pharma Development, 399 Thornall Street, Edison, NJ 08837, United States, Jason Mann, +001 732 5905011, jamann@dsi.com
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    Yes
    EMA paediatric investigation plan number(s)
    EMEA-000897-PIP01-10
    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
    13 Dec 2004
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    13 Dec 2004
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The main objective of this study was to determine if the compounded suspension formulation of olmesartan medoxomil (4 milligrams per milliliter [mg/mL] × 10 mL, for a total dose of 40 mg) is bioequivalent to the marketed tablet formulation of Benicar (1 × 40 mg tablet).
    Protection of trial subjects
    Safety variables included clinical and laboratory adverse events, concomitant medications, physical examination findings, vital signs, electrocardiogram (ECG) results, and hematology, serum chemistry, and urinalysis laboratory results.
    Background therapy
    -
    Evidence for comparator
    -
    Actual start date of recruitment
    24 Oct 2004
    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
    United States: 26
    Worldwide total number of subjects
    26
    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)
    0
    Children (2-11 years)
    0
    Adolescents (12-17 years)
    0
    Adults (18-64 years)
    26
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

    Close Top of page
    Recruitment
    Recruitment details
    Participants were screened from 24 October 2004 to 14 November 2004.

    Pre-assignment
    Screening details
    A total of 26 subjects were enrolled and randomized into the study. Of these 24 subjects completed the study.

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

    Arms
    Are arms mutually exclusive
    No

    Arm title
    Sequence AB
    Arm description
    Subjects were administered with 10 milliliter (ml) (4 milligram per milliliter [mg/ml]) olmesartan medoxomil oral suspension (Treatment A) on Day 1 of Period 1 and 40 mg of olmesartan medoxomil tablet (Benicar) (Treatment B) on Day 1 of Period 2. Both the periods were separated by a washout period of 7 days.
    Arm type
    Experimental

    Investigational medicinal product name
    Olmesartan Medoxomil
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Oral suspension
    Routes of administration
    Oral use
    Dosage and administration details
    Subjects were administered with olmesartan medoxomil oral suspension (Benicar 20 mg tablets dispersed in a vehicle containing water, Ora-Plus, and Ora-Sweet) on Day 1 of either Period 1 or Period 2 with 240 ml of water.

    Investigational medicinal product name
    Olmesartan Medoxomil
    Investigational medicinal product code
    Other name
    Benicar
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Subjects were administered with 40 mg of olmesartan medoxomil tablet on Day 1 of either Period 1 or Period 2 with 240 ml of water.

    Arm title
    Sequence BA
    Arm description
    Subjects were administered with 40 mg of olmesartan medoxomil tablet (Treatment B) on Day 1 of Period 1 and 10 mL (4 mg/mL) olmesartan medoxomil oral suspension (Treatment A) on Day 1 of Period 2. Both the periods were separated by a washout period of 7 days.
    Arm type
    Active comparator

    Investigational medicinal product name
    Olmesartan Medoxomil
    Investigational medicinal product code
    Other name
    Benicar
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Subjects were administered with 40 mg of olmesartan medoxomil tablet on Day 1 of either Period 1 or Period 2 with 240 ml of water.

    Investigational medicinal product name
    Olmesartan Medoxomil
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Oral suspension
    Routes of administration
    Oral use
    Dosage and administration details
    Subjects were administered with olmesartan medoxomil oral suspension (Benicar 20 mg tablets dispersed in a vehicle containing water, Ora-Plus, and Ora-Sweet) on Day 1 of either Period 1 or Period 2 with 240 ml of water.

    Number of subjects in period 1
    Sequence AB Sequence BA
    Started
    13
    13
    Completed
    13
    11
    Not completed
    0
    2
         Physician decision
    -
    1
         Lost to follow-up
    -
    1

    Baseline characteristics

    Close Top of page
    Baseline characteristics reporting groups
    Reporting group title
    Sequence AB
    Reporting group description
    Subjects were administered with 10 milliliter (ml) (4 milligram per milliliter [mg/ml]) olmesartan medoxomil oral suspension (Treatment A) on Day 1 of Period 1 and 40 mg of olmesartan medoxomil tablet (Benicar) (Treatment B) on Day 1 of Period 2. Both the periods were separated by a washout period of 7 days.

    Reporting group title
    Sequence BA
    Reporting group description
    Subjects were administered with 40 mg of olmesartan medoxomil tablet (Treatment B) on Day 1 of Period 1 and 10 mL (4 mg/mL) olmesartan medoxomil oral suspension (Treatment A) on Day 1 of Period 2. Both the periods were separated by a washout period of 7 days.

    Reporting group values
    Sequence AB Sequence BA Total
    Number of subjects
    13 13 26
    Age categorical
    Units: Subjects
        In utero
    0 0 0
        Preterm newborn infants (gestational age < 37 wks)
    0 0 0
        Newborns (0-27 days)
    0 0 0
        Infants and toddlers (28 days-23 months)
    0 0 0
        Children (2-11 years)
    0 0 0
        Adolescents (12-17 years)
    0 0 0
        Adults (18-64 years)
    13 13 26
        From 65-84 years
    0 0 0
        85 years and over
    0 0 0
    Gender categorical
    Units: Subjects
        Female
    2 2 4
        Male
    11 11 22

    End points

    Close Top of page
    End points reporting groups
    Reporting group title
    Sequence AB
    Reporting group description
    Subjects were administered with 10 milliliter (ml) (4 milligram per milliliter [mg/ml]) olmesartan medoxomil oral suspension (Treatment A) on Day 1 of Period 1 and 40 mg of olmesartan medoxomil tablet (Benicar) (Treatment B) on Day 1 of Period 2. Both the periods were separated by a washout period of 7 days.

    Reporting group title
    Sequence BA
    Reporting group description
    Subjects were administered with 40 mg of olmesartan medoxomil tablet (Treatment B) on Day 1 of Period 1 and 10 mL (4 mg/mL) olmesartan medoxomil oral suspension (Treatment A) on Day 1 of Period 2. Both the periods were separated by a washout period of 7 days.

    Subject analysis set title
    Treatment A
    Subject analysis set type
    Per protocol
    Subject analysis set description
    Subjects included who were received at least one dose of 10 mL (4 mg/mL) olmesartan medoxomil oral suspension on Day 1 of either Period 1 or Period 2 with 240 ml of water.

    Subject analysis set title
    Treatment B
    Subject analysis set type
    Per protocol
    Subject analysis set description
    Subjects included who were received at least one dose of 40 mg of olmesartan medoxomil tablet on Day 1 of either Period 1 or Period 2 with 240 ml of water.

    Primary: Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUC0-t) of Olmesartan Medoxomil

    Close Top of page
    End point title
    Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUC0-t) of Olmesartan Medoxomil
    End point description
    The AUC(0-t) is the area under the curve from time zero to last quantifiable concentration of olmesartan medoxomil. Pharmacokinetic population included all subjects who received at least one dose of study drug and had a valid Pharmacokinetic profile.
    End point type
    Primary
    End point timeframe
    Pre-dose, and 0.25, 0.5, 0.75, 1, 1.333, 1.667, 2, 2.5, 3, 4, 6, 8, 12, 16, 24, 36, 48 and 60 hours post-dose after each treatment period
    End point values
    Treatment A Treatment B
    Number of subjects analysed
    24
    26
    Units: nanogram*hour per milliliter (ng*hr/mL)
        geometric mean (geometric coefficient of variation)
    6812.6 ± 24.3
    6358.5 ± 27
    Statistical analysis title
    Statistical Analysis: AUC0-t
    Statistical analysis description
    The statistical analyses were performed using the SAS® Mixed Procedure. There were a total of 26 subjects included in this analysis (cross-over design).
    Comparison groups
    Treatment A v Treatment B
    Number of subjects included in analysis
    50
    Analysis specification
    Pre-specified
    Analysis type
    equivalence
    Method
    Parameter type
    Geometric Means Ratio
    Point estimate
    105.2
    Confidence interval
         level
    90%
         sides
    2-sided
         lower limit
    97.7
         upper limit
    113.3

    Primary: Maximum Observed Plasma Concentration (Cmax) of Olmesartan Medoxomil

    Close Top of page
    End point title
    Maximum Observed Plasma Concentration (Cmax) of Olmesartan Medoxomil
    End point description
    The Cmax is the maximum observed plasma concentration of olmesartan medoxomil. Pharmacokinetic population included all subjects who received at least one dose of study drug and had a valid Pharmacokinetic profile.
    End point type
    Primary
    End point timeframe
    Pre-dose, and 0.25, 0.5, 0.75, 1, 1.333, 1.667, 2, 2.5, 3, 4, 6, 8, 12, 16, 24, 36, 48 and 60 hours post-dose after each treatment period
    End point values
    Treatment A Treatment B
    Number of subjects analysed
    24
    26
    Units: nanogram /milliliter (ng/mL)
        geometric mean (geometric coefficient of variation)
    1036.9 ± 27.3
    949.6 ± 27.9
    Statistical analysis title
    Statistical Analysis: Cmax
    Statistical analysis description
    The statistical analyses were performed using the SAS® Mixed Procedure. There were a total of 26 subjects included in this analysis (cross-over design).
    Comparison groups
    Treatment A v Treatment B
    Number of subjects included in analysis
    50
    Analysis specification
    Pre-specified
    Analysis type
    equivalence
    Method
    Parameter type
    Geometric Means Ratio
    Point estimate
    106.6
    Confidence interval
         level
    90%
         sides
    2-sided
         lower limit
    97.8
         upper limit
    116.3

    Primary: Area Under the Concentration-time Curve From Time Zero to Infinity (AUC0-inf) of Olmesartan Medoxomil

    Close Top of page
    End point title
    Area Under the Concentration-time Curve From Time Zero to Infinity (AUC0-inf) of Olmesartan Medoxomil
    End point description
    The AUC (0-infinity) is the area under the plasma concentration-time curve from time zero to infinite time, calculated as the sum of AUC(last) and C(last)/lambda(z); wherein AUC(last) is area under the plasma concentration-time curve from time zero to last quantifiable time, C(last) is the last observed quantifiable concentration, and lambda(z) is elimination rate constant. Pharmacokinetic population included all subjects who received at least one dose of study drug and had a valid Pharmacokinetic profile. Here 'number of subject analysed' is the number of subject analysed for this outcome measure.
    End point type
    Primary
    End point timeframe
    Pre-dose, and 0.25, 0.5, 0.75, 1, 1.333, 1.667, 2, 2.5, 3, 4, 6, 8, 12, 16, 24, 36, 48 and 60 hours post-dose after each treatment period
    End point values
    Treatment A Treatment B
    Number of subjects analysed
    20
    23
    Units: nanogram*hour per milliliter (ng*hr/mL)
        geometric mean (geometric coefficient of variation)
    7184.2 ± 26.6
    6594.3 ± 28
    Statistical analysis title
    Statistical Analysis: AUC0-inf
    Statistical analysis description
    The statistical analyses were performed using the SAS® Mixed Procedure. There were a total of 23 subjects included in this analysis (cross-over design).
    Comparison groups
    Treatment A v Treatment B
    Number of subjects included in analysis
    43
    Analysis specification
    Pre-specified
    Analysis type
    equivalence
    Method
    Parameter type
    Geometric Means Ratio
    Point estimate
    107.2
    Confidence interval
         level
    90%
         sides
    2-sided
         lower limit
    97.5
         upper limit
    117.9

    Primary: Ratio of AUC0-t to AUC0-inf (AUC0-t to AUCinf) of Olmesartan Medoxomil

    Close Top of page
    End point title
    Ratio of AUC0-t to AUC0-inf (AUC0-t to AUCinf) of Olmesartan Medoxomil [1]
    End point description
    Ratio of AUC0-t to AUC0-inf (AUC0-t to AUCinf) of olmesartan medoxomil. Here number of subject analysed' is the number of subject analysed for this outcome measure. Pharmacokinetic population included all subjects who received at least one dose of study drug and had a valid Pharmacokinetic profile.
    End point type
    Primary
    End point timeframe
    Pre-dose, and 0.25, 0.5, 0.75, 1, 1.333, 1.667, 2, 2.5, 3, 4, 6, 8, 12, 16, 24, 36, 48 and 60 hours post-dose after each treatment period
    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: Descriptive statistics were done, no inferential statistical analyses were performed.
    End point values
    Treatment A Treatment B
    Number of subjects analysed
    20
    23
    Units: Ratio
        arithmetic mean (standard deviation)
    0.9722 ± 0.03137
    0.9745 ± 0.0219
    No statistical analyses for this end point

    Adverse events

    Close Top of page
    Adverse events information
    Timeframe for reporting adverse events
    From the start of the study treatment up to Day 3 of Period 2 (approximately 11 days)
    Assessment type
    Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    MedDRA
    Dictionary version
    7.1
    Reporting groups
    Reporting group title
    Treatment A
    Reporting group description
    Subjects included who were received at least one dose of 10 mL (4 mg/mL) olmesartan medoxomil oral suspension on Day 1 of either Period 1 or Period 2 with 240 ml of water.

    Reporting group title
    Treatment B
    Reporting group description
    Subjects included who were received at least one dose of 40 mg of olmesartan medoxomil tablet on Day 1 of either Period 1 or Period 2 with 240 ml of water.

    Serious adverse events
    Treatment A Treatment B
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 13 (0.00%)
    0 / 11 (0.00%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    Treatment A Treatment B
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    2 / 13 (15.38%)
    2 / 11 (18.18%)
    Injury, poisoning and procedural complications
    Joint sprain
         subjects affected / exposed
    0 / 13 (0.00%)
    1 / 11 (9.09%)
         occurrences all number
    0
    1
    Nervous system disorders
    Dizziness
         subjects affected / exposed
    0 / 13 (0.00%)
    1 / 11 (9.09%)
         occurrences all number
    0
    1
    Headache
         subjects affected / exposed
    1 / 13 (7.69%)
    0 / 11 (0.00%)
         occurrences all number
    1
    0
    General disorders and administration site conditions
    Asthenia
         subjects affected / exposed
    0 / 13 (0.00%)
    1 / 11 (9.09%)
         occurrences all number
    0
    1
    Fatigue
         subjects affected / exposed
    1 / 13 (7.69%)
    1 / 11 (9.09%)
         occurrences all number
    1
    1
    Gastrointestinal disorders
    Nausea
         subjects affected / exposed
    1 / 13 (7.69%)
    0 / 11 (0.00%)
         occurrences all number
    1
    0

    More information

    Close Top of page

    Substantial protocol amendments (globally)

    Were there any global substantial amendments to the protocol? No

    Interruptions (globally)

    Were there any global interruptions to the trial? No

    Limitations and caveats

    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    None reported
    For support, visit the EMA Service Desk , log in using your EMA account and open a ticket specifying "EU CTR" in your request.
    If you do not have an account, please visit the EMA Account management page page click on "Create an EMA account" and follow the instructions.
    The status of studies in GB is no longer updated from 1.1.2021
    For the UK, as from 1.1.2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI
    EU Clinical Trials Register Service Desk: https://servicedesk.ema.europa.eu
    European Medicines Agency © 1995-2021 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    Legal notice
    EMA HMA