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    Clinical Trial Results:
    A Dose-ranging, Safety and Pharmacokinetics Study of Candesartan Cilexetil in Hypertensive Pediatric Subjects 1 to Less Than 6 Years of Age: A 4-week, Multicenter, Randomized, Double-Blind Study with a 1-year Open-label, Follow-up Period

    Summary
    EudraCT number
    2004-004264-75
    Trial protocol
    BE   GB   DE   DK   IT  
    Global end of trial date
    07 Aug 2008

    Results information
    Results version number
    v1(current)
    This version publication date
    09 Mar 2016
    First version publication date
    09 Mar 2016
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    D2451C0002
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    NCT00244621
    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
    25 Mar 2009
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    07 Aug 2008
    Global end of trial reached?
    Yes
    Global end of trial date
    07 Aug 2008
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The primary objective of this study was to characterize the dose response relationship of candesartan cilexetil (administered once daily) in hypertensive pediatric subjects (1 to <6 years of age) by evaluation of the slope of the linear regression for the change in trough systolic blood pressure (SBP) from baseline (Day 0) to the end of the 4-week, double-blind treatment period (Day 28) as a function of dose.
    Protection of trial subjects
    The study ICI and the AstraZeneca Study Physician reviewed and discussed each SAE. In addition, an independant pediatric hypertension expert not otherwise participating in the study reviewed all SAEs, Aes and Aes leading to discontinuation of study drug.
    Background therapy
    -
    Evidence for comparator
    -
    Actual start date of recruitment
    04 Nov 2004
    Long term follow-up planned
    Yes
    Long term follow-up rationale
    Efficacy, Safety
    Long term follow-up duration
    12 Months
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Åland Islands: 93
    Worldwide total number of subjects
    93
    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)
    16
    Children (2-11 years)
    77
    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
    The study population included male and female participants 1 to <6 years of age with mild to moderate hypertension. The participants were recruited during the time period from 04 November 2004 to 07 August 2008 at pediatric clinics in the USA, Puerto Rico and Europe.

    Pre-assignment
    Screening details
    One to 2 weeks following a screening evaluation, participants underwent a 1-week, single-blind, placebo run-in period to reduce the variability in the baseline blood pressure measurements and to stabilize any concurrent antihypertensive medications.

    Period 1
    Period 1 title
    Double-blind treatment period
    Is this the baseline period?
    Yes
    Allocation method
    Randomised - controlled
    Blinding used
    Double blind
    Roles blinded
    Investigator, Monitor, Subject, Carer, Data analyst, Assessor

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    Atacand .05 mg
    Arm description
    candesartan cilexetil (Atacand) 0.05 mg/kg once daily oral liquid dose
    Arm type
    Experimental

    Investigational medicinal product name
    Candesartan cilexetil
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Oral liquid
    Routes of administration
    Oral use
    Dosage and administration details
    .05mg

    Arm title
    Atacand .20 mg
    Arm description
    candesartan cilexetil (Atacand) 0.20 mg/kg once daily oral liquid dose
    Arm type
    Experimental

    Investigational medicinal product name
    Candesartan cilexetil
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Oral liquid
    Routes of administration
    Oral use
    Dosage and administration details
    .20mg

    Arm title
    Atacand .40 mg
    Arm description
    candesartan cilexetil (Atacand) 0.40 mg/kg once daily oral liquid dose
    Arm type
    Experimental

    Investigational medicinal product name
    Candesartan cilexetil
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Oral liquid
    Routes of administration
    Oral use
    Dosage and administration details
    .40mg

    Number of subjects in period 1
    Atacand .05 mg Atacand .20 mg Atacand .40 mg
    Started
    29
    32
    32
    Completed
    27
    29
    30
    Not completed
    2
    3
    2
         Multiple Reasons
    2
    1
    1
         Lack of efficacy
    -
    1
    -
         Consent withdrawn by subject
    -
    1
    -
         Lost to follow-up
    -
    -
    1
    Period 2
    Period 2 title
    Open-label treatment period
    Is this the baseline period?
    No
    Allocation method
    Randomised - controlled
    Blinding used
    Double blind
    Roles blinded
    Subject, Investigator, Monitor, Carer, Data analyst, Assessor

    Arms
    Arm title
    Open-Label
    Arm description
    -
    Arm type
    Follow-up

    Investigational medicinal product name
    Candesartan cilexetil
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Oral liquid
    Routes of administration
    Oral use
    Dosage and administration details
    0.05mg

    Number of subjects in period 2 [1]
    Open-Label
    Started
    85
    Completed
    81
    Not completed
    4
         Moved abroad
    1
         Adverse event, serious fatal
    1
         Consent withdrawn by subject
    1
         Lost to follow-up
    1
    Notes
    [1] - The number of subjects starting the period is not consistent with the number completing the preceding period. It is expected the number of subjects starting the subsequent period will be the same as the number completing the preceding period.
    Justification: One participant discontinued study due to Adverse Event after completing the double-blind period

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Atacand .05 mg
    Reporting group description
    candesartan cilexetil (Atacand) 0.05 mg/kg once daily oral liquid dose

    Reporting group title
    Atacand .20 mg
    Reporting group description
    candesartan cilexetil (Atacand) 0.20 mg/kg once daily oral liquid dose

    Reporting group title
    Atacand .40 mg
    Reporting group description
    candesartan cilexetil (Atacand) 0.40 mg/kg once daily oral liquid dose

    Reporting group values
    Atacand .05 mg Atacand .20 mg Atacand .40 mg Total
    Number of subjects
    29 32 32 93
    Age categorical
    Units: Subjects
        Children (1-5)
    29 32 32 93
    Age continuous
    Units: years
        arithmetic mean (full range (min-max))
    3 (1 to 5) 3.3 (1 to 5) 3 (1 to 5) -
    Gender, Male/Female
    Units: Participants
        Female
    11 10 12 33
        Male
    18 22 20 60
    Age, Customized
    Units: Subjects
        1 to <2 years
    6 5 5 16
        2 to <6 years
    23 27 27 77

    End points

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    End points reporting groups
    Reporting group title
    Atacand .05 mg
    Reporting group description
    candesartan cilexetil (Atacand) 0.05 mg/kg once daily oral liquid dose

    Reporting group title
    Atacand .20 mg
    Reporting group description
    candesartan cilexetil (Atacand) 0.20 mg/kg once daily oral liquid dose

    Reporting group title
    Atacand .40 mg
    Reporting group description
    candesartan cilexetil (Atacand) 0.40 mg/kg once daily oral liquid dose
    Reporting group title
    Open-Label
    Reporting group description
    -

    Primary: Mean change from baseline to week 4 in systolic blood pressure (SBP)

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    End point title
    Mean change from baseline to week 4 in systolic blood pressure (SBP)
    End point description
    End point type
    Primary
    End point timeframe
    From randomisation to end of double-blind treatment (4 weeks)
    End point values
    Atacand .05 mg Atacand .20 mg Atacand .40 mg
    Number of subjects analysed
    29
    32
    32
    Units: mm Hg
        arithmetic mean (standard deviation)
    -6 ± 9.4
    -8.9 ± 9.2
    -12 ± 8.3
    Statistical analysis title
    Linear Regression
    Statistical analysis description
    The response variable was the change from baseline to the end of the double-blind treatment period in trough SBP.
    Comparison groups
    Atacand .05 mg v Atacand .20 mg v Atacand .40 mg
    Number of subjects included in analysis
    93
    Analysis specification
    Pre-specified
    Analysis type
    superiority [1]
    P-value
    < 0.0136
    Method
    Regression, Linear
    Parameter type
    Mean difference (final values)
    Point estimate
    -0.8
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -1.436
         upper limit
    -0.1692
    Variability estimate
    Standard deviation
    Notes
    [1] - The independent variables were dose ratio and weight group as a blocking factor.

    Secondary: Mean change from baseline to week 4 in diastolic blood pressure (DBP)

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    End point title
    Mean change from baseline to week 4 in diastolic blood pressure (DBP)
    End point description
    End point type
    Secondary
    End point timeframe
    From randomisation to end of double-blind treatment (4 weeks)
    End point values
    Atacand .05 mg Atacand .20 mg Atacand .40 mg
    Number of subjects analysed
    29
    32
    32
    Units: mm Hg
        arithmetic mean (standard deviation)
    -5.2 ± 6.7
    -7.9 ± 12.9
    -11.1 ± 9.2
    No statistical analyses for this end point

    Secondary: Change in albumin/creatinine (A/C) ratio for each assigned dose level from baseline to Day 28

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    End point title
    Change in albumin/creatinine (A/C) ratio for each assigned dose level from baseline to Day 28
    End point description
    End point type
    Secondary
    End point timeframe
    From randomisation to day 28
    End point values
    Atacand .05 mg Atacand .20 mg Atacand .40 mg
    Number of subjects analysed
    19
    19
    19
    Units: Percent change
        median (inter-quartile range (Q1-Q3))
    -11.1 (-42.5 to 33.3)
    -40.6 (-68.1 to 25)
    -50 (-68.9 to 15.8)
    No statistical analyses for this end point

    Secondary: Change in protein/creatinine (P/C) ratio for each assigned dose level from baseline to Day 28

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    End point title
    Change in protein/creatinine (P/C) ratio for each assigned dose level from baseline to Day 28
    End point description
    End point type
    Secondary
    End point timeframe
    From randomisation to day 28
    End point values
    Atacand .05 mg Atacand .20 mg Atacand .40 mg
    Number of subjects analysed
    25
    26
    27
    Units: Percent change
        median (inter-quartile range (Q1-Q3))
    0 (-25 to 50)
    -29.2 (-50 to 0)
    0 (-40.7 to 0)
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    From randomisation (study day 0) to end of study (week 56).
    Assessment type
    Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    MedDRA
    Dictionary version
    NA
    Reporting groups
    Reporting group title
    Atacand .05 mg
    Reporting group description
    candesartan cilexetil (Atacand) 0.05 mg/kg once daily oral liquid dose

    Reporting group title
    Atacand .20 mg
    Reporting group description
    candesartan cilexetil (Atacand) 0.20 mg/kg once daily oral liquid dose

    Reporting group title
    Atacand .40 mg
    Reporting group description
    candesartan cilexetil (Atacand) 0.40 mg/kg once daily oral liquid dose

    Reporting group title
    Open-Label
    Reporting group description
    -

    Serious adverse events
    Atacand .05 mg Atacand .20 mg Atacand .40 mg Open-Label
    Total subjects affected by serious adverse events
         subjects affected / exposed
    1 / 29 (3.45%)
    0 / 32 (0.00%)
    1 / 32 (3.13%)
    14 / 85 (16.47%)
         number of deaths (all causes)
    0
    0
    1
    1
         number of deaths resulting from adverse events
    0
    0
    0
    1
    Vascular disorders
    Vena Cava Thrombosis
         subjects affected / exposed
    0 / 29 (0.00%)
    0 / 32 (0.00%)
    0 / 32 (0.00%)
    1 / 85 (1.18%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    Post procedural haemorrhage
         subjects affected / exposed
    0 / 29 (0.00%)
    0 / 32 (0.00%)
    0 / 32 (0.00%)
    1 / 85 (1.18%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Immune system disorders
    drug hypersensitivity
         subjects affected / exposed
    0 / 29 (0.00%)
    0 / 32 (0.00%)
    0 / 32 (0.00%)
    1 / 85 (1.18%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Blood and lymphatic system disorders
    Catheter Site Haematoma
    alternative dictionary used: MedDRA 11.0
         subjects affected / exposed
    1 / 29 (3.45%)
    0 / 32 (0.00%)
    0 / 32 (0.00%)
    1 / 85 (1.18%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    Lymphadenitis cervical
         subjects affected / exposed
    0 / 29 (0.00%)
    0 / 32 (0.00%)
    0 / 32 (0.00%)
    1 / 85 (1.18%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Pyrexia drug
         subjects affected / exposed
    0 / 29 (0.00%)
    0 / 32 (0.00%)
    0 / 32 (0.00%)
    2 / 85 (2.35%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Catheter site necrosis
         subjects affected / exposed
    0 / 29 (0.00%)
    0 / 32 (0.00%)
    0 / 32 (0.00%)
    1 / 85 (1.18%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Renal and urinary disorders
    Glomerulonephritis
    Additional description: Chronic
         subjects affected / exposed
    0 / 29 (0.00%)
    0 / 32 (0.00%)
    0 / 32 (0.00%)
    1 / 85 (1.18%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    1 / 1
    Nephrotic Syndrome
         subjects affected / exposed
    0 / 29 (0.00%)
    0 / 32 (0.00%)
    0 / 32 (0.00%)
    1 / 85 (1.18%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    Urinary Tract Infection
    alternative dictionary used: MedDRA 11.0
         subjects affected / exposed
    0 / 29 (0.00%)
    0 / 32 (0.00%)
    1 / 32 (3.13%)
    3 / 85 (3.53%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Bronchiolitis
         subjects affected / exposed
    0 / 29 (0.00%)
    0 / 32 (0.00%)
    0 / 32 (0.00%)
    1 / 85 (1.18%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    External ear cellulitis NOS
         subjects affected / exposed
    0 / 29 (0.00%)
    0 / 32 (0.00%)
    0 / 32 (0.00%)
    1 / 85 (1.18%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pneumonia
         subjects affected / exposed
    0 / 29 (0.00%)
    0 / 32 (0.00%)
    0 / 32 (0.00%)
    1 / 85 (1.18%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pneumonia parainfluenzae viral
         subjects affected / exposed
    0 / 29 (0.00%)
    0 / 32 (0.00%)
    0 / 32 (0.00%)
    1 / 85 (1.18%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pyelonephritis acute NOS
         subjects affected / exposed
    0 / 29 (0.00%)
    0 / 32 (0.00%)
    0 / 32 (0.00%)
    1 / 85 (1.18%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Upper respiratory tract infection
         subjects affected / exposed
    0 / 29 (0.00%)
    0 / 32 (0.00%)
    0 / 32 (0.00%)
    1 / 85 (1.18%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    Atacand .05 mg Atacand .20 mg Atacand .40 mg Open-Label
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    18 / 29 (62.07%)
    20 / 32 (62.50%)
    18 / 32 (56.25%)
    64 / 85 (75.29%)
    Injury, poisoning and procedural complications
    Excoriation
         subjects affected / exposed
    2 / 29 (6.90%)
    0 / 32 (0.00%)
    0 / 32 (0.00%)
    1 / 85 (1.18%)
         occurrences all number
    2
    0
    0
    1
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    2 / 29 (6.90%)
    2 / 32 (6.25%)
    4 / 32 (12.50%)
    32 / 85 (37.65%)
         occurrences all number
    2
    2
    4
    32
    Rhinorrhoea
         subjects affected / exposed
    3 / 29 (10.34%)
    2 / 32 (6.25%)
    2 / 32 (6.25%)
    12 / 85 (14.12%)
         occurrences all number
    3
    2
    2
    12
    Asthma
         subjects affected / exposed
    2 / 29 (6.90%)
    0 / 32 (0.00%)
    0 / 32 (0.00%)
    2 / 85 (2.35%)
         occurrences all number
    2
    0
    0
    2
    Nasal congestion
         subjects affected / exposed
    0 / 29 (0.00%)
    0 / 32 (0.00%)
    0 / 32 (0.00%)
    5 / 85 (5.88%)
         occurrences all number
    0
    0
    0
    5
    Nervous system disorders
    Headache
         subjects affected / exposed
    1 / 29 (3.45%)
    3 / 32 (9.38%)
    0 / 32 (0.00%)
    5 / 85 (5.88%)
         occurrences all number
    1
    3
    0
    5
    Eye disorders
    Conjunctivitis
         subjects affected / exposed
    0 / 29 (0.00%)
    0 / 32 (0.00%)
    1 / 32 (3.13%)
    7 / 85 (8.24%)
         occurrences all number
    0
    0
    1
    7
    General disorders and administration site conditions
    Pyrexia
         subjects affected / exposed
    4 / 29 (13.79%)
    5 / 32 (15.63%)
    4 / 32 (12.50%)
    32 / 85 (37.65%)
         occurrences all number
    4
    5
    4
    32
    Fatigue
         subjects affected / exposed
    3 / 29 (10.34%)
    1 / 32 (3.13%)
    1 / 32 (3.13%)
    3 / 85 (3.53%)
         occurrences all number
    3
    1
    1
    3
    Gastrointestinal disorders
    Diarrhoea
         subjects affected / exposed
    2 / 29 (6.90%)
    3 / 32 (9.38%)
    0 / 32 (0.00%)
    12 / 85 (14.12%)
         occurrences all number
    2
    3
    0
    12
    Vomiting
         subjects affected / exposed
    2 / 29 (6.90%)
    0 / 32 (0.00%)
    0 / 32 (0.00%)
    11 / 85 (12.94%)
         occurrences all number
    2
    0
    0
    11
    Abdominal pain
         subjects affected / exposed
    1 / 29 (3.45%)
    1 / 32 (3.13%)
    0 / 32 (0.00%)
    5 / 85 (5.88%)
         occurrences all number
    1
    1
    0
    5
    Metabolism and nutrition disorders
    Decreased appetite
         subjects affected / exposed
    2 / 29 (6.90%)
    0 / 32 (0.00%)
    0 / 32 (0.00%)
    2 / 85 (2.35%)
         occurrences all number
    2
    0
    0
    2
    Infections and infestations
    Upper respiratory tract infection
         subjects affected / exposed
    2 / 29 (6.90%)
    5 / 32 (15.63%)
    3 / 32 (9.38%)
    15 / 85 (17.65%)
         occurrences all number
    2
    5
    3
    15
    Nasopharyngitis
         subjects affected / exposed
    1 / 29 (3.45%)
    1 / 32 (3.13%)
    1 / 32 (3.13%)
    15 / 85 (17.65%)
         occurrences all number
    1
    1
    1
    15
    Otitis media
         subjects affected / exposed
    0 / 29 (0.00%)
    2 / 32 (6.25%)
    0 / 32 (0.00%)
    13 / 85 (15.29%)
         occurrences all number
    0
    2
    0
    13
    Urinary tract infection
         subjects affected / exposed
    0 / 29 (0.00%)
    0 / 32 (0.00%)
    2 / 32 (6.25%)
    10 / 85 (11.76%)
         occurrences all number
    0
    0
    2
    10
    Bronchitis
         subjects affected / exposed
    1 / 29 (3.45%)
    0 / 32 (0.00%)
    0 / 32 (0.00%)
    9 / 85 (10.59%)
         occurrences all number
    1
    0
    0
    9
    Pharyngitis
         subjects affected / exposed
    2 / 29 (6.90%)
    0 / 32 (0.00%)
    1 / 32 (3.13%)
    6 / 85 (7.06%)
         occurrences all number
    2
    0
    1
    6
    Gastroenteritis
         subjects affected / exposed
    0 / 29 (0.00%)
    0 / 32 (0.00%)
    0 / 32 (0.00%)
    6 / 85 (7.06%)
         occurrences all number
    0
    0
    0
    6
    Rhinitis
         subjects affected / exposed
    2 / 29 (6.90%)
    0 / 32 (0.00%)
    2 / 32 (6.25%)
    7 / 85 (8.24%)
         occurrences all number
    2
    0
    2
    7

    More information

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    Substantial protocol amendments (globally)

    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    20 Feb 2006
    Centres have been added to reach enrolment goals
    20 Jul 2007
    Revision in blood pressure measurement.
    12 Feb 2008
    No interim analyses planned but amendment 2 provides the authorithy to analyse the double-blind dose response phase without waiting until long term open label phase is completed
    12 Feb 2008
    Echocardiography is added following recommendation from the Paediatric Committee at EMEA

    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

    Online references

    http://www.ncbi.nlm.nih.gov/pubmed/20160654
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