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    Clinical Trial Results:
    An Open-label Extension Study of Candesartan Cilexetil in Hypertensive Pediatric Subjects Ages 1 to <11 Years: A Long-term Study

    Summary
    EudraCT number
    2007-001545-17
    Trial protocol
    DE   BE   FR   PL   IT  
    Global end of trial date
    09 Sep 2009

    Results information
    Results version number
    v1(current)
    This version publication date
    16 Apr 2016
    First version publication date
    16 Apr 2016
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    D2451C00006
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    NCT00690612
    WHO universal trial number (UTN)
    -
    Sponsors
    Sponsor organisation name
    AstraZeneca
    Sponsor organisation address
    Pepparedsleden 1, Molndal, Sweden, 431 83
    Public contact
    Robin Mukherjee, R&D/GMD/Biometrics & Information Sciences, robin.mukherjee@astrazeneca.com
    Scientific contact
    Robin Mukherjee, R&D/GMD/Biometrics & Information Sciences, robin.mukherjee@astrazeneca.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
    09 Sep 2009
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    09 Sep 2009
    Global end of trial reached?
    Yes
    Global end of trial date
    09 Sep 2009
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The primary objective of this study was to describe the long-term clinical experience of candesartan cilexetil in hypertensive children ages 1 to <11 years who had participated in Protocol 328 (D2451C00002) without discontinuation due to a study drug-related AE, and who had an ongoing clinical indication for treatment with candesartan cilexetil.
    Protection of trial subjects
    The study ICI and the AstraZeneca Study Physician reviewed and discussed each SAE. In addition, an independent pediatric hypertension expert not otherwise participating in the study reviewed all SAEs, AEs, and AEs leading to discontinuation (DAEs) of the study drug. The safety committee consisting of the ICI and the independent expert met 3 times; minutes from the meetings are archived with the sponsor.
    Background therapy
    -
    Evidence for comparator
    -
    Actual start date of recruitment
    17 Sep 2007
    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
    Belgium: 6
    Country: Number of subjects enrolled
    Denmark: 6
    Country: Number of subjects enrolled
    France: 6
    Country: Number of subjects enrolled
    Italy: 6
    Country: Number of subjects enrolled
    Poland: 6
    Country: Number of subjects enrolled
    Ukraine: 5
    Worldwide total number of subjects
    35
    EEA total number of subjects
    30
    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)
    35
    Adolescents (12-17 years)
    0
    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
    Hypertensive children aged 1 to <11 years who had participated in the 1-year study (Protocol 328, D2451C00002-NCT00244621). First patient enrolled 17 Sep 2007 and last patient completed 9 Sep 2009 at Pediatric clinics in Europe.

    Pre-assignment
    Screening details
    Patients who had participated in the 1-year study (Protocol 328, D2451C00002-NCT00244621) and did not discontinue study due to a study drug-related adverse event (AE) and had an ongoing clinical indication for treatment with candesartan.

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

    Arms
    Arm title
    Overall
    Arm description
    Overall
    Arm type
    Follow-up

    Investigational medicinal product name
    Candesartan Cilexetil
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Concentrate for oral suspension
    Routes of administration
    Oral use
    Dosage and administration details
    0.05, 0.20 and 0.40 mg

    Number of subjects in period 1
    Overall
    Started
    35
    Completed
    32
    Not completed
    3
         Adverse event, non-fatal
             1
         Consent withdrawn by subject
             2

    Baseline characteristics

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

    Reporting group values
    Overall Study Total
    Number of subjects
    35 35
    Age categorical
    Units: Subjects
        2-5
    24 24
        6-11
    11 11
    Age Continuous |
    Units: Years
        arithmetic mean (standard deviation)
    4.4 ± 1.6 -
    Gender, Male/Female
    Units: participants
        Female
    10 10
        Male
    25 25

    End points

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    End points reporting groups
    Reporting group title
    Overall
    Reporting group description
    Overall

    Primary: Mean change from baseline to final visit in systolic blood pressure (SBP).

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    End point title
    Mean change from baseline to final visit in systolic blood pressure (SBP). [1]
    End point description
    Blood pressure response was defined as Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) less than the 95th percentile based on population height-adjusted charts for age and gender. Response rates were based on the proportion of patients meeting the criteria at each evaluation time point or the last available measure.
    End point type
    Primary
    End point timeframe
    Every 3 months- baseline to final visit
    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: No statistical analyses in the sense of hypothesis testing were carried out for the primary endpoints.
    End point values
    Overall
    Number of subjects analysed
    35
    Units: Millimeters of Mercury (mm Hg)
        arithmetic mean (standard deviation)
    -2.86 ± 11.97
    No statistical analyses for this end point

    Primary: Mean change from baseline to final visit in diastolic blood pressure (DBP).

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    End point title
    Mean change from baseline to final visit in diastolic blood pressure (DBP). [2]
    End point description
    Blood pressure response was defined as Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) less than the 95th percentile based on population height-adjusted charts for age and gender. Response rates were based on the proportion of patients meeting the criteria at each evaluation time point or the last available measure.
    End point type
    Primary
    End point timeframe
    every 3 months - baseline to final visit
    Notes
    [2] - 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: No statistical analyses in the sense of hypothesis testing were carried out for the primary endpoint.
    End point values
    Overall
    Number of subjects analysed
    35
    Units: mm Hg
        arithmetic mean (standard deviation)
    -0.43 ± 12.26
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    During the entire study period; from 14 days before patient received study medication to end of study (month 27).
    Assessment type
    Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    MedDRA
    Dictionary version
    NA
    Reporting groups
    Reporting group title
    Atacand candesartan cilexetil
    Reporting group description
    candesartan cilexetil (Atacand) approximately 0.05 mg/kg, 0.2 mg/kg, and 0.4 mg/kg doses administered in oral suspension form.

    Serious adverse events
    Atacand candesartan cilexetil
    Total subjects affected by serious adverse events
         subjects affected / exposed
    3 / 35 (8.57%)
         number of deaths (all causes)
    0
         number of deaths resulting from adverse events
    0
    Blood and lymphatic system disorders
    Lymphoedema
    alternative dictionary used: MedDRA 10.0
         subjects affected / exposed
    1 / 35 (2.86%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Metabolism and nutrition disorders
    Hyperkalaemia
    alternative dictionary used: MedDRA 10.0
         subjects affected / exposed
    1 / 35 (2.86%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Infections and infestations
    Bronchopneumonia
    alternative dictionary used: MedDRA 10.0
         subjects affected / exposed
    1 / 35 (2.86%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 2%
    Non-serious adverse events
    Atacand candesartan cilexetil
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    28 / 35 (80.00%)
    Respiratory, thoracic and mediastinal disorders
    COUGH
    alternative dictionary used: MedDRA 10.0
         subjects affected / exposed
    5 / 35 (14.29%)
         occurrences all number
    5
    UPPER RESPIRATORY TRACT INFLAMMATION
    alternative dictionary used: MedDRA 10.0
         subjects affected / exposed
    2 / 35 (5.71%)
         occurrences all number
    2
    General disorders and administration site conditions
    PYREXIA
    alternative dictionary used: MedDRA 10.0
         subjects affected / exposed
    9 / 35 (25.71%)
         occurrences all number
    9
    FATIGUE
    alternative dictionary used: MedDRA 10.0
         subjects affected / exposed
    2 / 35 (5.71%)
         occurrences all number
    2
    Gastrointestinal disorders
    Diarrhoea
    alternative dictionary used: MedDRA 10.0
         subjects affected / exposed
    6 / 35 (17.14%)
         occurrences all number
    6
    Nausea
    alternative dictionary used: MedDRA 10.0
         subjects affected / exposed
    3 / 35 (8.57%)
         occurrences all number
    3
    VOMITING
    alternative dictionary used: MedDRA 10.0
         subjects affected / exposed
    3 / 35 (8.57%)
         occurrences all number
    3
    Renal and urinary disorders
    ENURESIS
    alternative dictionary used: MedDRA 10.0
         subjects affected / exposed
    3 / 35 (8.57%)
         occurrences all number
    3
    Infections and infestations
    PHARYNGITIS
    alternative dictionary used: MedDRA 10.0
         subjects affected / exposed
    6 / 35 (17.14%)
         occurrences all number
    6
    RHINITIS
    alternative dictionary used: MedDRA 10.0
         subjects affected / exposed
    6 / 35 (17.14%)
         occurrences all number
    6
    NASOPHARYNGITIS
    alternative dictionary used: MedDRA 10.0
         subjects affected / exposed
    4 / 35 (11.43%)
         occurrences all number
    4
    BRONCHITIS
    alternative dictionary used: MedDRA 10.0
         subjects affected / exposed
    3 / 35 (8.57%)
         occurrences all number
    3
    UPPER RESPIRATORY TRACT INFECTION
    alternative dictionary used: MedDRA 10.0
         subjects affected / exposed
    3 / 35 (8.57%)
         occurrences all number
    3
    VARICELLA
    alternative dictionary used: MedDRA 10.0
         subjects affected / exposed
    3 / 35 (8.57%)
         occurrences all number
    3
    ACUTE TONSILLITIS
    alternative dictionary used: MedDRA 10.0
         subjects affected / exposed
    2 / 35 (5.71%)
         occurrences all number
    2
    GASTROENTERITIS
    alternative dictionary used: MedDRA 10.0
         subjects affected / exposed
    2 / 35 (5.71%)
         occurrences all number
    2
    INFLUENZA
    alternative dictionary used: MedDRA 10.0
         subjects affected / exposed
    2 / 35 (5.71%)
         occurrences all number
    2
    OTITIS MEDIA
    alternative dictionary used: MedDRA 10.0
         subjects affected / exposed
    2 / 35 (5.71%)
         occurrences all number
    2
    OTITIS MEDIA ACUTE
    alternative dictionary used: MedDRA 10.0
         subjects affected / exposed
    2 / 35 (5.71%)
         occurrences all number
    2
    TONSILLITIS
    alternative dictionary used: MedDRA 10.0
         subjects affected / exposed
    2 / 35 (5.71%)
         occurrences all number
    2
    URINARY TRACT INFECTION
    alternative dictionary used: MedDRA 10.0
         subjects affected / exposed
    2 / 35 (5.71%)
         occurrences all number
    2

    More information

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    Substantial protocol amendments (globally)

    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    24 Jul 2007
    Echocardiography (ECHO) is added following recommendation from the Paedeatric Committee (PDCO) at the European Medicines Agency’s (EMEA).
    11 Feb 2008
    The investigator or designated cardiologist will perform an echocardiogram (ECHO) at study entry and then annually during the course of this study.

    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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