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    Clinical Trial Results:
    Acceptability, safety, pharmacokinetics and effects on blood pressure of paediatric formulation of perindopril, S 90052 (0.020 to 0.110 mg/kg/d)/S 90652 (0.025 to 0.135 mg/kg/d), in hypertensive children. An open, noncomparative, 3-month then 24-month (minimal duration) multicentre study.

    Summary
    EudraCT number
    2005-000474-42
    Trial protocol
    IT  
    Global end of trial date
    27 Apr 2010

    Results information
    Results version number
    v1(current)
    This version publication date
    06 Jul 2016
    First version publication date
    31 Jul 2015
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    CL2-90652-002
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    -
    WHO universal trial number (UTN)
    -
    Sponsors
    Sponsor organisation name
    Institut de Recherches Internationales Servier
    Sponsor organisation address
    50 rue Carnot, Suresnes Cedex, France, 92284
    Public contact
    Therapeutic Innovation Pole, Institut de Recherches Internationales Servier 50 rue Carnot 92284 Suresnes Cedex, +33 155724366, clinicaltrials@servier.com
    Scientific contact
    Therapeutic Innovation Pole, Institut de Recherches Internationales Servier 50 rue Carnot 92284 Suresnes Cedex, +33 155724366, clinicaltrials@servier.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
    27 Apr 2010
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    27 Apr 2010
    Global end of trial reached?
    Yes
    Global end of trial date
    27 Apr 2010
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The main objective of the study was to assess the acceptability of S 90052/S 90652, the orodispersible formulation of perindopril and to assess the safety of S 90052/S 90652.
    Protection of trial subjects
    Temporary discontinuations of the study treatment were allowed during the study if a dose decreasing procedure was decided. Definitive discontinuations of the study drug were to be decided in case of serious adverse drug reaction(s), or adverse event(s) not compatible with the continuation of the study treatment, or insufficient BP control. In the extension part of the study, the apparition of signs of pubescence in girls was also a reason for definitive discontinuations of the study drug: A serious adverse reaction was defined as a serious adverse event that the investigator considered might be due to the research. Adverse events considered as not compatible with the continuation of the study drug were the following angioedema postural hypotension or occurrences of malaises, serum potassium level > 5.5 mEq/L and estimated GFR ≤ 25 mL/min/1.73m². Insufficient BP control was defined as the occurrence of a threatening hypertension; SBP or DBP equal to or above the 97.5th percentile + 30 mmHg the occurrence of a SBP or a DBP equal to or above the 95th percentile in spite of the administration of the maximal authorised dose of S 90652 in combination with additional antihypertensive agent(s).
    Background therapy
    -
    Evidence for comparator
    -
    Actual start date of recruitment
    16 Jul 2003
    Long term follow-up planned
    Yes
    Long term follow-up rationale
    Efficacy
    Long term follow-up duration
    48 Months
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Belgium: 11
    Country: Number of subjects enrolled
    France: 43
    Country: Number of subjects enrolled
    Italy: 8
    Worldwide total number of subjects
    62
    EEA total number of subjects
    62
    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)
    54
    Adolescents (12-17 years)
    8
    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
    In all, 20 centres located in Belgium, France and Italy were opened: four centres in Belgium, 15 centres in France and one centre in Italy. Eighteen centres selected at least one patient, and 17 centres included at least one patient.

    Pre-assignment
    Screening details
    -

    Pre-assignment period milestones
    Number of subjects started
    62
    Number of subjects completed
    62

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

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    Subgroup A
    Arm description
    Confirmed and untreated arterial hypertension (defined as a systolic blood pressure (SBP) or a diastolic blood pressure (DBP) equal to or above the 97.5th percentile + 10 mmHg).
    Arm type
    Experimental

    Investigational medicinal product name
    S 90052 (perindopril tert-butylamine salt)
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Orodispersible tablet
    Routes of administration
    Oral use
    Dosage and administration details
    0.020 mg/kg/day, oral

    Investigational medicinal product name
    S 90652 (perindopril arginine salt)
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Orodispersible tablet
    Routes of administration
    Oral use
    Dosage and administration details
    0.025 mg/kg/day, oral

    Arm title
    Subgroup B
    Arm description
    Arterial hypertension controlled with an ongoing treatment including an angiotensin-converting enzyme inhibitor (ACE-I) or other BP lowering medication(s), when the switch of the ACE-I (if an ACE-I was administered) or the switch of another BP lowering medication (if no ACE-I was administered) by S 90052/ S 90652 could be considered.
    Arm type
    Experimental

    Investigational medicinal product name
    S 90652 (perindopril arginine salt)
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Orodispersible tablet
    Routes of administration
    Oral use
    Dosage and administration details
    0.025 mg/kg/day, 0.050 mg/kg/day or 0.100 mg/kg/day, oral, depending upon the previous antihypertensive treatment.

    Investigational medicinal product name
    S 90052 (perindopril tert-butylamine salt)
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Orodispersible tablet
    Routes of administration
    Oral use
    Dosage and administration details
    0.020 mg/kg/day, 0.040 mg/kg/day or 0.080 mg/kg/day, oral

    Arm title
    Subgroup C
    Arm description
    Poorly controlled arterial hypertension treated with medication(s) that did not include any ACE-I, when the addition of S 90052/ S 90652 was expected to improve BP control.
    Arm type
    Experimental

    Investigational medicinal product name
    S 90052 (perindopril tert-butylamine salt)
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Orodispersible tablet
    Routes of administration
    Oral use
    Dosage and administration details
    0.020 mg/kg/day, oral

    Investigational medicinal product name
    S 90652 (perindopril arginine salt)
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Orodispersible tablet
    Routes of administration
    Oral use
    Dosage and administration details
    0.025 mg/kg/day, oral

    Number of subjects in period 1
    Subgroup A Subgroup B Subgroup C
    Started
    6
    51
    5
    Completed
    5
    27
    4
    Not completed
    1
    24
    1
         Adverse event, non-fatal
    -
    6
    -
         Lost to follow-up
    -
    1
    -
         Protocol deviation
    1
    5
    -
         Lack of efficacy
    -
    2
    -
         non medical reason
    -
    10
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Subgroup A
    Reporting group description
    Confirmed and untreated arterial hypertension (defined as a systolic blood pressure (SBP) or a diastolic blood pressure (DBP) equal to or above the 97.5th percentile + 10 mmHg).

    Reporting group title
    Subgroup B
    Reporting group description
    Arterial hypertension controlled with an ongoing treatment including an angiotensin-converting enzyme inhibitor (ACE-I) or other BP lowering medication(s), when the switch of the ACE-I (if an ACE-I was administered) or the switch of another BP lowering medication (if no ACE-I was administered) by S 90052/ S 90652 could be considered.

    Reporting group title
    Subgroup C
    Reporting group description
    Poorly controlled arterial hypertension treated with medication(s) that did not include any ACE-I, when the addition of S 90052/ S 90652 was expected to improve BP control.

    Reporting group values
    Subgroup A Subgroup B Subgroup C Total
    Number of subjects
    6 51 5 62
    Age categorical
    Units: Subjects
        In utero
    0 0 0 0
        Preterm newborn infants (gestational age < 37 wks)
    0 0 0 0
        Newborns (0-27 days)
    0 0 0 0
        Infants and toddlers (28 days-23 months)
    0 0 0 0
        Children (2-11 years)
    3 23 1 27
        Adolescents (12-17 years)
    3 28 4 35
        Adults (18-64 years)
    0 0 0 0
        From 65-84 years
    0 0 0 0
        85 years and over
    0 0 0 0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    4.8 ± 1.6 6.8 ± 3.9 9.4 ± 3.8 -
    Gender categorical
    Units: Subjects
        Female
    3 19 1 23
        Male
    3 32 4 39

    End points

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    End points reporting groups
    Reporting group title
    Subgroup A
    Reporting group description
    Confirmed and untreated arterial hypertension (defined as a systolic blood pressure (SBP) or a diastolic blood pressure (DBP) equal to or above the 97.5th percentile + 10 mmHg).

    Reporting group title
    Subgroup B
    Reporting group description
    Arterial hypertension controlled with an ongoing treatment including an angiotensin-converting enzyme inhibitor (ACE-I) or other BP lowering medication(s), when the switch of the ACE-I (if an ACE-I was administered) or the switch of another BP lowering medication (if no ACE-I was administered) by S 90052/ S 90652 could be considered.

    Reporting group title
    Subgroup C
    Reporting group description
    Poorly controlled arterial hypertension treated with medication(s) that did not include any ACE-I, when the addition of S 90052/ S 90652 was expected to improve BP control.

    Primary: No primary criterion

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    End point title
    No primary criterion [1]
    End point description
    End point type
    Primary
    End point timeframe
    No primary efficacy criterion was defined as the main objective was to study the safety of S 90052/S 90652.
    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 primary efficacy criterion was defined as the main objective was to study the safety of S 90052/S 90652.
    End point values
    Number of subjects analysed
    Units: Not applicable
    No statistical analyses for this end point

    Secondary: Evolution of systolic blood pressure over time until M24

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    End point title
    Evolution of systolic blood pressure over time until M24
    End point description
    Efficacy criteria were systolic blood pressure. No primary efficacy criterion was defined as the main objective was to study the safety of S 90052/S 90652.
    End point type
    Secondary
    End point timeframe
    From selection to last visit
    End point values
    Subgroup A Subgroup B Subgroup C
    Number of subjects analysed
    5 [2]
    51 [3]
    5 [4]
    Units: mmHg
        arithmetic mean (standard deviation)
    -7.8 ± 10.7
    0.8 ± 16.4
    -9.6 ± 13
    Attachments
    Statistical analysis_SBP
    Notes
    [2] - FAS
    [3] - FAS
    [4] - FAS
    No statistical analyses for this end point

    Secondary: Evolution of diastolic blood pressure over time until M24

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    End point title
    Evolution of diastolic blood pressure over time until M24
    End point description
    Efficacy criteria were systolic and diastolic blood pressures. No primary efficacy criterion was defined as the main objective was to study the safety of S 90052/S 90652.
    End point type
    Secondary
    End point timeframe
    From selection to last visit
    End point values
    Subgroup A Subgroup B Subgroup C
    Number of subjects analysed
    5 [5]
    51 [6]
    5 [7]
    Units: mmHg
        arithmetic mean (standard deviation)
    -13.2 ± 12.1
    -1 ± 14.1
    -11 ± 4.8
    Attachments
    Statistical analysis_DBP
    Notes
    [5] - FAS
    [6] - FAS
    [7] - FAS
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Over the course of the study
    Assessment type
    Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    MedDRA
    Dictionary version
    5.0
    Reporting groups
    Reporting group title
    Subgroup A
    Reporting group description
    -

    Reporting group title
    Subgroup C
    Reporting group description
    -

    Reporting group title
    Subgroup B
    Reporting group description
    -

    Serious adverse events
    Subgroup A Subgroup C Subgroup B
    Total subjects affected by serious adverse events
         subjects affected / exposed
    4 / 6 (66.67%)
    5 / 5 (100.00%)
    28 / 51 (54.90%)
         number of deaths (all causes)
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    Vascular disorders
    Hypertension NOS
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    1 / 51 (1.96%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Hypertensive crisis
         subjects affected / exposed
    0 / 6 (0.00%)
    1 / 5 (20.00%)
    2 / 51 (3.92%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Orthostatic hypotension
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    1 / 51 (1.96%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Fall
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    1 / 51 (1.96%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Influenza like illness
         subjects affected / exposed
    0 / 6 (0.00%)
    1 / 5 (20.00%)
    0 / 51 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Immune system disorders
    Transplant rejection
         subjects affected / exposed
    0 / 6 (0.00%)
    1 / 5 (20.00%)
    1 / 51 (1.96%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Liver transplant rejection
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    1 / 51 (1.96%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Tonsillar hypertrophy
         subjects affected / exposed
    0 / 6 (0.00%)
    2 / 5 (40.00%)
    0 / 51 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Adenoidal hypertrophy
         subjects affected / exposed
    0 / 6 (0.00%)
    1 / 5 (20.00%)
    0 / 51 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pharyngitis
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    1 / 51 (1.96%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Investigations
    Biopsy kidney
         subjects affected / exposed
    0 / 6 (0.00%)
    2 / 5 (40.00%)
    6 / 51 (11.76%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 7
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Transplant evaluation
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    1 / 51 (1.96%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Weight decreased
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    1 / 51 (1.96%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Investigations NOS
         subjects affected / exposed
    0 / 6 (0.00%)
    2 / 5 (40.00%)
    0 / 51 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    Accidental overdose
         subjects affected / exposed
    1 / 6 (16.67%)
    0 / 5 (0.00%)
    0 / 51 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Joint sprain
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    1 / 51 (1.96%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Therapeutic agent toxicity
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    1 / 51 (1.96%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Upper limb fracture NOS
         subjects affected / exposed
    1 / 6 (16.67%)
    0 / 5 (0.00%)
    0 / 51 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Congenital, familial and genetic disorders
    Multiple epiphyseal dysplasia
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    1 / 51 (1.96%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Nervous system disorders
    Dyskinesia
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    1 / 51 (1.96%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Obstructive sleep apnoea syndrome
         subjects affected / exposed
    1 / 6 (16.67%)
    0 / 5 (0.00%)
    0 / 51 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Headache
         subjects affected / exposed
    0 / 6 (0.00%)
    1 / 5 (20.00%)
    0 / 51 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Blood and lymphatic system disorders
    Haemolytic anaemia NOS
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    1 / 51 (1.96%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Diarrhoea NOS
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    4 / 51 (7.84%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Gastroenteritis NOS
         subjects affected / exposed
    0 / 6 (0.00%)
    2 / 5 (40.00%)
    1 / 51 (1.96%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Anal polyp
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    1 / 51 (1.96%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Gingival hypertrophy
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    2 / 51 (3.92%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Colonic polyp
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    1 / 51 (1.96%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Appendicitis
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    1 / 51 (1.96%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Inguinal hernia NOS
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    1 / 51 (1.96%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Vomiting NOS
         subjects affected / exposed
    0 / 6 (0.00%)
    1 / 5 (20.00%)
    0 / 51 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Hepatobiliary disorders
    Cholangitis NOS
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    1 / 51 (1.96%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Hepatic failure
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    1 / 51 (1.96%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Skin and subcutaneous tissue disorders
    Rash NOS
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    1 / 51 (1.96%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Henoch-Schonlein purpura
         subjects affected / exposed
    0 / 6 (0.00%)
    1 / 5 (20.00%)
    0 / 51 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Renal and urinary disorders
    Nephropathy NOS
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    2 / 51 (3.92%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Renal failure acute
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    2 / 51 (3.92%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Vesico-ureteric reflux
         subjects affected / exposed
    1 / 6 (16.67%)
    0 / 5 (0.00%)
    1 / 51 (1.96%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Nephrotic syndrome
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    1 / 51 (1.96%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Neurogenic bladder
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    1 / 51 (1.96%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Proteinuria aggravated
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    1 / 51 (1.96%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Urinary tract operation
         subjects affected / exposed
    1 / 6 (16.67%)
    0 / 5 (0.00%)
    0 / 51 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Adenotonsillectomy
         subjects affected / exposed
    0 / 6 (0.00%)
    1 / 5 (20.00%)
    0 / 51 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Angioplasty
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    1 / 51 (1.96%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Bladder catheter removal
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    1 / 51 (1.96%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Tonsillectomy
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    1 / 51 (1.96%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Enema administration
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    1 / 51 (1.96%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Otorhinolaryngological surgery
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    1 / 51 (1.96%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    0 / 6 (0.00%)
    1 / 5 (20.00%)
    0 / 51 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Epiphysiolysis
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    1 / 51 (1.96%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Jaw cyst
         subjects affected / exposed
    0 / 6 (0.00%)
    1 / 5 (20.00%)
    0 / 51 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    Gastroenteritis viral NOS
         subjects affected / exposed
    0 / 6 (0.00%)
    1 / 5 (20.00%)
    2 / 51 (3.92%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pyelonephritis acute NOS
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    2 / 51 (3.92%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Viral infection NOS
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    2 / 51 (3.92%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Cytomegalovirus infection
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    1 / 51 (1.96%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Peritonitis pneumococcal
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    1 / 51 (1.96%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Herpetic stomatitis
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    1 / 51 (1.96%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Epstein-Barr virus infection
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    1 / 51 (1.96%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Meningitis enteroviral
         subjects affected / exposed
    0 / 6 (0.00%)
    1 / 5 (20.00%)
    0 / 51 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Otitis media serous chronic NOS
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    1 / 51 (1.96%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pharyngitis streptococcal
         subjects affected / exposed
    0 / 6 (0.00%)
    1 / 5 (20.00%)
    0 / 51 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pneumonia mycoplasmal
         subjects affected / exposed
    0 / 6 (0.00%)
    1 / 5 (20.00%)
    0 / 51 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pneumonia NOS
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    1 / 51 (1.96%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Streptococcal sepsis
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    1 / 51 (1.96%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Varicella
         subjects affected / exposed
    0 / 6 (0.00%)
    1 / 5 (20.00%)
    0 / 51 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Metabolism and nutrition disorders
    Dehydration
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    1 / 51 (1.96%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Diabetes mellitus NOS
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    1 / 51 (1.96%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Malnutrition NOS
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    1 / 51 (1.96%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    Subgroup A Subgroup C Subgroup B
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    6 / 6 (100.00%)
    5 / 5 (100.00%)
    45 / 51 (88.24%)
    Investigations
    Biopsy kidney
         subjects affected / exposed
    0 / 6 (0.00%)
    2 / 5 (40.00%)
    6 / 51 (11.76%)
         occurrences all number
    0
    2
    7
    Nervous system disorders
    Headache
         subjects affected / exposed
    2 / 6 (33.33%)
    1 / 5 (20.00%)
    8 / 51 (15.69%)
         occurrences all number
    2
    1
    12
    General disorders and administration site conditions
    Pyrexia
         subjects affected / exposed
    0 / 6 (0.00%)
    1 / 5 (20.00%)
    4 / 51 (7.84%)
         occurrences all number
    0
    5
    4
    Influenza like illness
         subjects affected / exposed
    0 / 6 (0.00%)
    1 / 5 (20.00%)
    4 / 51 (7.84%)
         occurrences all number
    0
    1
    4
    Blood and lymphatic system disorders
    Anaemia NOS
         subjects affected / exposed
    0 / 6 (0.00%)
    1 / 5 (20.00%)
    4 / 51 (7.84%)
         occurrences all number
    0
    1
    4
    Ear and labyrinth disorders
    Ear pain
         subjects affected / exposed
    1 / 6 (16.67%)
    0 / 5 (0.00%)
    3 / 51 (5.88%)
         occurrences all number
    1
    0
    4
    Gastrointestinal disorders
    Gastroenteritis NOS
         subjects affected / exposed
    3 / 6 (50.00%)
    2 / 5 (40.00%)
    13 / 51 (25.49%)
         occurrences all number
    6
    3
    19
    Diarrhoea NOS
         subjects affected / exposed
    1 / 6 (16.67%)
    1 / 5 (20.00%)
    7 / 51 (13.73%)
         occurrences all number
    2
    1
    11
    Abdominal pain upper
         subjects affected / exposed
    2 / 6 (33.33%)
    2 / 5 (40.00%)
    4 / 51 (7.84%)
         occurrences all number
    2
    3
    6
    Gingival hypertrophy
         subjects affected / exposed
    0 / 6 (0.00%)
    1 / 5 (20.00%)
    4 / 51 (7.84%)
         occurrences all number
    0
    1
    4
    Respiratory, thoracic and mediastinal disorders
    Nasopharyngitis
         subjects affected / exposed
    1 / 6 (16.67%)
    3 / 5 (60.00%)
    11 / 51 (21.57%)
         occurrences all number
    2
    4
    13
    Pharyngitis
         subjects affected / exposed
    2 / 6 (33.33%)
    1 / 5 (20.00%)
    9 / 51 (17.65%)
         occurrences all number
    2
    1
    9
    Cough
         subjects affected / exposed
    0 / 6 (0.00%)
    2 / 5 (40.00%)
    7 / 51 (13.73%)
         occurrences all number
    0
    2
    7
    Rhinitis allergic NOS
         subjects affected / exposed
    1 / 6 (16.67%)
    0 / 5 (0.00%)
    3 / 51 (5.88%)
         occurrences all number
    1
    0
    7
    Skin and subcutaneous tissue disorders
    Ingrowing nail
         subjects affected / exposed
    0 / 6 (0.00%)
    1 / 5 (20.00%)
    3 / 51 (5.88%)
         occurrences all number
    0
    1
    4
    Rash NOS
         subjects affected / exposed
    0 / 6 (0.00%)
    1 / 5 (20.00%)
    3 / 51 (5.88%)
         occurrences all number
    0
    2
    3
    Renal and urinary disorders
    Nephropathy NOS
         subjects affected / exposed
    0 / 6 (0.00%)
    1 / 5 (20.00%)
    3 / 51 (5.88%)
         occurrences all number
    0
    1
    3
    Infections and infestations
    Urinary tract infection NOS
         subjects affected / exposed
    0 / 6 (0.00%)
    2 / 5 (40.00%)
    9 / 51 (17.65%)
         occurrences all number
    0
    7
    15
    Bronchitis acute NOS
         subjects affected / exposed
    0 / 6 (0.00%)
    1 / 5 (20.00%)
    9 / 51 (17.65%)
         occurrences all number
    0
    1
    12
    Rhinitis NOS
         subjects affected / exposed
    2 / 6 (33.33%)
    1 / 5 (20.00%)
    7 / 51 (13.73%)
         occurrences all number
    2
    1
    10
    Respiratory tract infection NOS
         subjects affected / exposed
    0 / 6 (0.00%)
    2 / 5 (40.00%)
    7 / 51 (13.73%)
         occurrences all number
    0
    8
    13
    Ear infection NOS
         subjects affected / exposed
    1 / 6 (16.67%)
    1 / 5 (20.00%)
    5 / 51 (9.80%)
         occurrences all number
    2
    2
    10
    Bronchitis NOS
         subjects affected / exposed
    0 / 6 (0.00%)
    1 / 5 (20.00%)
    6 / 51 (11.76%)
         occurrences all number
    0
    1
    7
    Upper respiratory tract infection NOS
         subjects affected / exposed
    0 / 6 (0.00%)
    2 / 5 (40.00%)
    4 / 51 (7.84%)
         occurrences all number
    0
    6
    5
    Viral infection NOS
         subjects affected / exposed
    0 / 6 (0.00%)
    1 / 5 (20.00%)
    4 / 51 (7.84%)
         occurrences all number
    0
    1
    5
    Herpes simplex
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    5 / 51 (9.80%)
         occurrences all number
    0
    0
    5
    Gastroenteritis viral NOS
         subjects affected / exposed
    0 / 6 (0.00%)
    1 / 5 (20.00%)
    3 / 51 (5.88%)
         occurrences all number
    0
    3
    4
    Influenza
         subjects affected / exposed
    1 / 6 (16.67%)
    1 / 5 (20.00%)
    2 / 51 (3.92%)
         occurrences all number
    1
    1
    2
    Varicella
         subjects affected / exposed
    0 / 6 (0.00%)
    1 / 5 (20.00%)
    3 / 51 (5.88%)
         occurrences all number
    0
    1
    3

    More information

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    Substantial protocol amendments (globally)

    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    17 Nov 2003
    The number of centres, the duration of the study, the study drug new formulation, the dosages and the assay centre for perindopril and perindoprilat assays. The protocol code changed from CL2-90052-002 to CL2-90652-001: - Due to the rate of inclusion lower than expected, the total number of centres was increased from 8 to 20. - For the same reason, the duration of the recruitment (12 months) was extended to 18 months and the duration of the study from 16 months to 22 months. - Perindopril tert-butylamine salt was replaced by arginine salt. The doses were modified to take into account the different molecular weights of the two salts; the packaging and the information/informed consent forms were modified. Upon approval of the amendment, the patients to be enrolled in the study received S 90652. Ongoing patients at the time of the implementation of the amendment completed D120 visit with S 90052. - Due to the small volume of blood collected from children, the assay centre AAI (Applied Analytical Industries), located in Germany, experienced difficulties to extract sufficient amounts of perindopril and perindoprilat from the small volume samples (0.2 mL). Therefore, the decision was made to have perindopril and perindoprilat assays performed by Technologie SERVIER (TES) in France, where the method had been validated.
    24 Sep 2004
    Included the following changes: - The study initially planned in French paediatric centres was extended to European paediatric centres. The total number of centres was increased to 20. - The duration of the recruitment (18 months) was extended to 36 months and the duration of the study from 22 months to 40 months. - The upper age limit was raised to 16 years old in boys. The information/informed consent form was modified accordingly.
    11 Sep 2008
    This amendment allowed to obtain echocardiographic data from exams performed within the usual medical follow-up of the patients but outside the study. Exams performed before study treatment initiation and after at least two years of study treatment were concerned, and allowed to assess cardiac function and structure parameters in hypertensive children. Concerning ongoing patients, if there was no echocardiographic data available (under study treatment) after at least two years of study treatment, an echocardiography was to be performed at one of the follow up visits. Each participant (if capable) and his/her parents were asked to sign an additional consent form.

    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.
    The section NSAE presented EAEs on treatment and included SEAEs. The causality and seriousness of reported SAE can be ultimately upgraded by the sponsor. The sponsor took these decisions to be compliant with the existing ICH E3 Clinical Study Report.
    For support, Contact us.
    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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