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    Clinical Trial Results:
    An Open-label Study of the Single-dose Pharmacokinetics of Olmesartan Medoxomil in Pediatric Patients With Hypertension

    Summary
    EudraCT number
    		 2015-003328-30
    Trial protocol
    		 Outside EU/EEA  
    Global end of trial date
    06 Feb 2008

    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

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    Trial identification
    Sponsor protocol code
    CS0866-A-U102
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT00151814
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Daiichi Sankyo Pharma Development
    Sponsor organisation address
    399 Thornall Street, Edison, United States, 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)
    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
    06 Feb 2008
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    06 Feb 2008
    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 the single-dose Pharmacokinetics of olmesartan following oral administration of a pro-drug, Olmesartan medoxomil (OM), in pediatric subjects with hypertension ages 12 months to 16 years.
    Protection of trial subjects
    The safety assessments included clinical laboratory tests (hematology, serum chemistry and urinalysis), Electrocardiogram, Physical examination findings and Vital signs. Adverse events were monitored throughout the study.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    27 Sep 2005
    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: 24
    Worldwide total number of subjects
    24
    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)
    14
    Adolescents (12-17 years)
    10
    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
    		 The recruitment period was from September 2005 to February 2008. This period lasted for this length of time because of difficulties in recruiting subjects. Children from 12 months old to 16 years old were to be enrolled.

    Pre-assignment
    Screening details
    		 A total of 33 subjects were screened, of these 24 subjects were enrolled and completed the study. No subjects in the 12-23 month old category were enrolled.

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

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Olmesartan Group - 2 to 5 years old
    Arm description
    		 Subjects who were less than (<) 6 years old received single dose of Olmesartan medoxomil oral suspension, 0.3 milligram per kilogram body weight (mg/kg).
    Arm type
    		 Experimental

    Investigational medicinal product name
    Olmesartan Medoxomil
    Investigational medicinal product code
    Other name
    Benicar
    Pharmaceutical forms
    Oral suspension
    Routes of administration
    Oral use
    Dosage and administration details
    Subjects received single dose of Olmesartan Medoxomil oral suspension at a dose of 0.3 mg/kg.

    Arm title
    		 Olmesartan Group - 6 to 12 Years Old
    Arm description
    		 Subjects who were greater than or equal to (> =) 6 to 12 years old, with weight > or = 35 kg received single oral dose of Olmesartan medoxomil, 40 mg tablet; for subjects with weight less than (<) 35 kg the dose was 20 mg tablet.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Olmesartan Medoxomil
    Investigational medicinal product code
    Other name
    Benicar
    Pharmaceutical forms
    Film-coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Subjects who were greater than or equal to (> =) 6 to 12 years old, with weight > or = 35 kg received single oral dose of Olmesartan medoxomil, 40 mg tablet; for subjects with weight less than (<) 35 kg the dose was 20 mg tablet.

    Arm title
    		 Olmesartan Group - 13 to 16 Years Old
    Arm description
    		 Subjects who were > = 13 to 16 years old, with weight > or = 35 kg received single oral dose of Olmesartan medoxomil, 40 mg tablet; for subjects with weight < 35 kg the dose was 20 mg tablet.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Olmesartan Medoxomil
    Investigational medicinal product code
    Other name
    Benicar
    Pharmaceutical forms
    Film-coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Subjects who were > = 13 to 16 years old, with weight > or = 35 kg received single oral dose of Olmesartan medoxomil, 40 mg tablet; for subjects with weight < 35 kg the dose was 20 mg tablet.

    Number of subjects in period 1
    		Olmesartan Group - 2 to 5 years old Olmesartan Group - 6 to 12 Years Old Olmesartan Group - 13 to 16 Years Old
    Started
    4
    10
    10
    Completed
    4
    10
    10

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Olmesartan Group - 2 to 5 years old
    Reporting group description
    		 Subjects who were less than (<) 6 years old received single dose of Olmesartan medoxomil oral suspension, 0.3 milligram per kilogram body weight (mg/kg).

    Reporting group title
    Olmesartan Group - 6 to 12 Years Old
    Reporting group description
    		 Subjects who were greater than or equal to (> =) 6 to 12 years old, with weight > or = 35 kg received single oral dose of Olmesartan medoxomil, 40 mg tablet; for subjects with weight less than (<) 35 kg the dose was 20 mg tablet.

    Reporting group title
    Olmesartan Group - 13 to 16 Years Old
    Reporting group description
    		 Subjects who were > = 13 to 16 years old, with weight > or = 35 kg received single oral dose of Olmesartan medoxomil, 40 mg tablet; for subjects with weight < 35 kg the dose was 20 mg tablet.

    Reporting group values
    		 Olmesartan Group - 2 to 5 years old Olmesartan Group - 6 to 12 Years Old Olmesartan Group - 13 to 16 Years Old Total
    Number of subjects
    		 4 10 10 24
    Age categorical
    Units: Subjects
        Children (2-11 years)
    		 4 10 0 14
        Adolescents (12-17 years)
    		 0 0 10 10
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 4.8 ± 0.5 10.2 ± 1.03 14.8 ± 1.03 -
    Gender categorical
    Units: Subjects
        Female
    		 3 5 5 13
        Male
    		 1 5 5 11
    Height
    Units: centimeter (cm)
        arithmetic mean (standard deviation)
    		 116.7 ± 9.01 151.8 ± 9.44 165.5 ± 9.74 -
    Weight
    Units: kilogram (kg)
        arithmetic mean (standard deviation)
    		 32 ± 16.31 70.3 ± 20.53 86.3 ± 29.5 -

    End points

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    End points reporting groups
    Reporting group title
    Olmesartan Group - 2 to 5 years old
    Reporting group description
    		 Subjects who were less than (<) 6 years old received single dose of Olmesartan medoxomil oral suspension, 0.3 milligram per kilogram body weight (mg/kg).

    Reporting group title
    Olmesartan Group - 6 to 12 Years Old
    Reporting group description
    		 Subjects who were greater than or equal to (> =) 6 to 12 years old, with weight > or = 35 kg received single oral dose of Olmesartan medoxomil, 40 mg tablet; for subjects with weight less than (<) 35 kg the dose was 20 mg tablet.

    Reporting group title
    Olmesartan Group - 13 to 16 Years Old
    Reporting group description
    		 Subjects who were > = 13 to 16 years old, with weight > or = 35 kg received single oral dose of Olmesartan medoxomil, 40 mg tablet; for subjects with weight < 35 kg the dose was 20 mg tablet.

    Primary: Area Under the Concentration-time Curve From Time 0 to Time of last Quantifiable Concentration (AUC 0-t) of Olmesartan

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    End point title
    		 Area Under the Concentration-time Curve From Time 0 to Time of last Quantifiable Concentration (AUC 0-t) of Olmesartan [1] [2]
    End point description
    The AUC(0-last) is the area under the plasma concentration-time curve from time zero to last quantifiable concentration. Pharmacokinetic population included all randomized subjects who received study drug. The data for 2-5 years old subjects were not analyzed.
    End point type
    Primary
    End point timeframe
    Pre-dose and 1,2,4,8,12,24,48 hours post-dose
    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.
    [2] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: The data for Olmesartan Group - 2-5 years old subjects were not analyzed due to insufficient number of subjects.
    End point values
    		 Olmesartan Group - 6 to 12 Years Old Olmesartan Group - 13 to 16 Years Old
    Number of subjects analysed
    10
    10
    Units: nanogram per millilitre *hour (ng/mL*hr)
        arithmetic mean (standard deviation)
    7874 ± 2913
    5851 ± 2083
    No statistical analyses for this end point

    Primary: Area Under the Concentration-time Curve From Time Zero to Infinite Time (AUC[0-infinity]) of Olmesartan

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    End point title
    		 Area Under the Concentration-time Curve From Time Zero to Infinite Time (AUC[0-infinity]) of Olmesartan [3] [4]
    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 randomized subjects who received study drug. The data for 2-5 years old subjects were not analyzed.
    End point type
    Primary
    End point timeframe
    Pre-dose and 1,2,4,8,12,24,48 hours post-dose
    Notes
    [3] - 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.
    [4] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: The data for Olmesartan Group - 2-5 years old subjects were not analyzed due to insufficient number of subjects.
    End point values
    		 Olmesartan Group - 6 to 12 Years Old Olmesartan Group - 13 to 16 Years Old
    Number of subjects analysed
    10
    10
    Units: ng/mL*hr
        arithmetic mean (standard deviation)
    7988 ± 2913
    5982 ± 2130
    No statistical analyses for this end point

    Primary: Maximum Plasma Concentration (Cmax) of Olmesartan

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    End point title
    		 Maximum Plasma Concentration (Cmax) of Olmesartan [5] [6]
    End point description
    The Cmax is the maximum observed plasma concentration of Olmesartan. Pharmacokinetic population included all randomized subjects who received study drug. The data for 2-5 years old subjects were not analyzed.
    End point type
    Primary
    End point timeframe
    Pre-dose and 1,2,4,8,12,24,48 hours post-dose
    Notes
    [5] - 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.
    [6] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: The data for Olmesartan Group - 2-5 years old subjects were not analyzed due to insufficient number of subjects.
    End point values
    		 Olmesartan Group - 6 to 12 Years Old Olmesartan Group - 13 to 16 Years Old
    Number of subjects analysed
    10
    10
    Units: nanogram(s)/milliliter (ng/mL)
        arithmetic mean (standard deviation)
    1227 ± 451
    895 ± 262
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    From First administration of study drug up to 48 hours Post-dose
    Adverse event reporting additional description
    Adverse events observed by the Investigator, or reported by the subject, and any remedial action taken, were recorded in case report form by Investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the Investigator’s opinion of the causal relationship to the treatment.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    8.1
    Reporting groups
    Reporting group title
    Olmesartan Group - 2 to 5 years old
    Reporting group description
    		 Subjects who were less than (<) 6 years old received single dose of Olmesartan medoxomil oral suspension, 0.3 milligram per kilogram body weight (mg/kg).

    Reporting group title
    Olmesartan Group - 13 to 16 Years Old
    Reporting group description
    		 Subjects who were greater than or equal to (> =) 13 to 16 years old; > or = 35 kg weight was received single oral dose of Olmesartan medoxomil, 40 mg tablet; for < 35 kg the dose was 20 mg tablet.

    Reporting group title
    Olmesartan Group - 6 to 12 Years Old
    Reporting group description
    		 Subjects who were greater than or equal to (> =) 6 to 12 years old; > or = 35 kg weight was received single oral dose of Olmesartan medoxomil, 40 mg tablet; for < 35 kg the dose was 20 mg tablet.

    Serious adverse events
    		 Olmesartan Group - 2 to 5 years old Olmesartan Group - 13 to 16 Years Old Olmesartan Group - 6 to 12 Years Old
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 10 (0.00%)
    0 / 10 (0.00%)
         number of deaths (all causes)
    0
    0
    0
         number of deaths resulting from adverse events
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 Olmesartan Group - 2 to 5 years old Olmesartan Group - 13 to 16 Years Old Olmesartan Group - 6 to 12 Years Old
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    1 / 4 (25.00%)
    1 / 10 (10.00%)
    2 / 10 (20.00%)
    Investigations
    Abnormal urine analysis
         subjects affected / exposed
    0 / 4 (0.00%)
    1 / 10 (10.00%)
    0 / 10 (0.00%)
         occurrences all number
    0
    1
    0
    Nervous system disorders
    Headache
         subjects affected / exposed
    1 / 4 (25.00%)
    0 / 10 (0.00%)
    0 / 10 (0.00%)
         occurrences all number
    1
    0
    0
    Somnolence
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 10 (0.00%)
    1 / 10 (10.00%)
         occurrences all number
    0
    0
    1
    General disorders and administration site conditions
    Fatigue
         subjects affected / exposed
    1 / 4 (25.00%)
    0 / 10 (0.00%)
    0 / 10 (0.00%)
         occurrences all number
    1
    0
    0
    Gastrointestinal disorders
    Abdominal pain upper
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 10 (0.00%)
    1 / 10 (10.00%)
         occurrences all number
    0
    0
    1
    Diarrhea
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 10 (0.00%)
    1 / 10 (10.00%)
         occurrences all number
    0
    0
    1

    More information

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    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
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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