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    Clinical Trial Results:
    A phase IIIb, efficacy, and safety study of rosuvastatin in children and adolescents 10 to 17 years of age with heterozygous familial hypercholesterolemia (HeFH): a 12-week, double-blind, randomized, multi-center, placebo-controlled study with a 40-week, open-label, follow-up period.

    Summary
    EudraCT number
    2006-002616-96
    Trial protocol
    NL   ES   Outside EU/EEA  
    Global end of trial date
    04 Jun 2008

    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
    D3561C00087
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    NCT00355615
    WHO universal trial number (UTN)
    -
    Sponsors
    Sponsor organisation name
    AstraZeneca
    Sponsor organisation address
    Pepparedsleden 1, Mölndal, Sweden, SE-431 83
    Public contact
    Robin Mukherjee, R&D/GMD/Biometrics & Information Sciences, AZTrial_Results_Posting@astrazeneca.com
    Scientific contact
    Robin Mukherjee, R&D/GMD/Biometrics & Information Sciences, AZTrial_Results_Posting@astrazeneca.com
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    Yes
    EMA paediatric investigation plan number(s)
    EMEA-000022-PIP01-07
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    09 Mar 2009
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    04 Jun 2008
    Global end of trial reached?
    Yes
    Global end of trial date
    04 Jun 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 determine the efficacy of once-daily rosuvastatin in reducing LDL C in children and adolescents aged 10 17 years with HeFH from baseline to the end of the 12 week, double-blind treatment period.
    Protection of trial subjects
    An independent Safety Committee monitored blinded data for safety issues during the course of the study
    Background therapy
    -
    Evidence for comparator
    -
    Actual start date of recruitment
    28 Jul 2006
    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
    United States: 17
    Country: Number of subjects enrolled
    Canada: 65
    Country: Number of subjects enrolled
    Netherlands: 96
    Country: Number of subjects enrolled
    Norway: 29
    Country: Number of subjects enrolled
    Spain: 15
    Worldwide total number of subjects
    222
    EEA total number of subjects
    140
    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)
    48
    Adolescents (12-17 years)
    174
    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
    One-hundred male and female (Tanner stages II to V, at least 1 year post-menarche) children and adolescents (aged 10 to 17 years with Heterozygous familial hypercholesterolemia were randomized into the study, from 20 sites located in The United States (3 sites), The Netherlands (7 sites), Norway (1 site), Spain (3 sites), and Canada (6 sites).

    Pre-assignment
    Screening details
    Patients entered a 6 week dietary lead-in/drug washout period. Eligible patients were then randomly assigned to double-blind treatment with rosuvastatin 5 mg, 10 mg, 20 mg, or matching placebo, administered orally once daily for 12 weeks.

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

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    rosuva 5
    Arm description
    rosuvastatin 5 mg
    Arm type
    Experimental

    Investigational medicinal product name
    CRESTOR Rosuvastatin
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    5mg

    Arm title
    rosuva 10
    Arm description
    rosuvastatin 10 mg
    Arm type
    Experimental

    Investigational medicinal product name
    CRESTOR Rosuvastatin
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    10mg

    Arm title
    rosuva 20
    Arm description
    rosuvastatin 20 mg
    Arm type
    Experimental

    Investigational medicinal product name
    CRESTOR Rosuvastatin
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    20mg

    Arm title
    placebo
    Arm description
    placebo
    Arm type
    Placebo

    Investigational medicinal product name
    PLACEBO
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    NA

    Number of subjects in period 1 [1]
    rosuva 5 rosuva 10 rosuva 20 placebo
    Started
    42
    44
    45
    46
    Completed
    41
    43
    44
    45
    Not completed
    1
    1
    1
    1
         Protocol deviation
    -
    -
    1
    1
         Adverse event, non-fatal
    1
    -
    -
    -
         Consent withdrawn by subject
    -
    1
    -
    -
    Notes
    [1] - The number of subjects reported to be in the baseline period are not the same as the worldwide number enrolled in the trial. It is expected that these numbers will be the same.
    Justification: The number of subjects reported in the baseline period is not the same as the number enrolled as the week 0 baseline visit (#3) is preceded by two visits at weeks -6 and -1.
    Period 2
    Period 2 title
    40-week rosuvastatin open label period
    Is this the baseline period?
    No
    Allocation method
    Not applicable
    Blinding used
    Not blinded

    Arms
    Arm title
    rosuva ol
    Arm description
    rosuvastatin open label
    Arm type
    Experimental

    Investigational medicinal product name
    CRESTOR Rosuvastatin
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    20 mg

    Number of subjects in period 2
    rosuva ol
    Started
    173
    Completed
    164
    Not completed
    9
         Protocol deviation
    1
         Adverse event, non-fatal
    4
         investigational site closed
    1
         Consent withdrawn by subject
    3

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    rosuva 5
    Reporting group description
    rosuvastatin 5 mg

    Reporting group title
    rosuva 10
    Reporting group description
    rosuvastatin 10 mg

    Reporting group title
    rosuva 20
    Reporting group description
    rosuvastatin 20 mg

    Reporting group title
    placebo
    Reporting group description
    placebo

    Reporting group values
    rosuva 5 rosuva 10 rosuva 20 placebo Total
    Number of subjects
    42 44 45 46 177
    Age categorical
    Units: Subjects
        Children (2-11 years)
    2 0 0 1 3
        Adolescents (12-17 years)
    40 44 45 45 174
    Age Continuous |
    Units: years
        arithmetic mean (full range (min-max))
    14.3 (10 to 17) 14.6 (11 to 18) 14.4 (11 to 18) 14.4 (10 to 17) -
    Gender, Male/Female
    Units: Participants
        Female
    26 25 22 24 97
        Male
    16 19 23 22 80

    End points

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    End points reporting groups
    Reporting group title
    rosuva 5
    Reporting group description
    rosuvastatin 5 mg

    Reporting group title
    rosuva 10
    Reporting group description
    rosuvastatin 10 mg

    Reporting group title
    rosuva 20
    Reporting group description
    rosuvastatin 20 mg

    Reporting group title
    placebo
    Reporting group description
    placebo
    Reporting group title
    rosuva ol
    Reporting group description
    rosuvastatin open label

    Primary: Percent change in low-density lipoprotein cholesterol (LDL-C) from baseline (Day 0) to the end of the 12-week double-blind treatment phase

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    End point title
    Percent change in low-density lipoprotein cholesterol (LDL-C) from baseline (Day 0) to the end of the 12-week double-blind treatment phase
    End point description
    Percent change in low-density lipoprotein cholesterol (LDL-C) = (final value - Baseline value)/Baseline value * 100
    End point type
    Primary
    End point timeframe
    12 weeks
    End point values
    rosuva 5 rosuva 10 rosuva 20 placebo
    Number of subjects analysed
    42
    44
    44
    46
    Units: percentage
        arithmetic mean (standard deviation)
    -38.5 ± 11.38
    -44.4 ± 12.15
    -50.2 ± 13.3
    -0.5 ± 13.18
    Statistical analysis title
    Change from randomization to Week 12 in LDL-C
    Statistical analysis description
    Analysis of Covariance (ANCOVA) with the baseline LDL-C as a covariate and including treatment as a fixed effect.
    Comparison groups
    rosuva 5 v placebo
    Number of subjects included in analysis
    88
    Analysis specification
    Pre-specified
    Analysis type
    superiority [1]
    P-value
    < 0.001
    Method
    ANCOVA
    Parameter type
    LS Mean
    Point estimate
    -37.5
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -42.8
         upper limit
    -32.3
    Variability estimate
    Standard deviation
    Notes
    [1] - Rosuvastatin difference vs placebo
    Statistical analysis title
    Change from randomization to week 12 in LDL-C
    Statistical analysis description
    Analysis of Covariance (ANCOVA) witht the baseline LDL-C as covariate and including treatment as fixed effect.
    Comparison groups
    rosuva 10 v placebo
    Number of subjects included in analysis
    90
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    < 0.001
    Method
    ANCOVA
    Parameter type
    LS Mean
    Point estimate
    -44.6
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -49.1
         upper limit
    -38.8
    Variability estimate
    Standard deviation
    Statistical analysis title
    Change from randomization to Week 12 in LDL-C
    Statistical analysis description
    Analysis of Covariance (ANCOVA) with the baseline LDL-C as a covariate and including treatment as a fixed effect.
    Comparison groups
    rosuva 20 v placebo
    Number of subjects included in analysis
    90
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    < 0.001
    Method
    ANCOVA
    Parameter type
    LS Mean
    Point estimate
    -50
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -54.4
         upper limit
    -44.1
    Variability estimate
    Standard deviation

    Secondary: Percent change in LDL-C and other lipid parameters from baseline to Week 6, and at end of double-blind dose treatment phase (Week 12)

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    End point title
    Percent change in LDL-C and other lipid parameters from baseline to Week 6, and at end of double-blind dose treatment phase (Week 12)
    End point description
    Percent change from baseline in LDL-C after six week of treatment
    End point type
    Secondary
    End point timeframe
    6 weeks
    End point values
    rosuva 5 rosuva 10 rosuva 20 placebo
    Number of subjects analysed
    42
    44
    44
    46
    Units: percentage
        arithmetic mean (standard deviation)
    -40.3 ± 12.22
    -45.2 ± 11.15
    -50 ± 11.42
    -0.6 ± 13.63
    No statistical analyses for this end point

    Secondary: Percent control rate based on achievement of LDL-C target of <110 mg/dL during double-blind dose treatment

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    End point title
    Percent control rate based on achievement of LDL-C target of <110 mg/dL during double-blind dose treatment
    End point description
    Percent of patients achieving LDL-C < 110 mg/dL out of the total patients in each treatment group
    End point type
    Secondary
    End point timeframe
    12 weeks
    End point values
    rosuva 5 rosuva 10 rosuva 20 placebo
    Number of subjects analysed
    42
    44
    44
    46
    Units: Percent of Participants
        number (not applicable)
    11.9
    40.9
    40.9
    0
    No statistical analyses for this end point

    Secondary: Percent change in HDL-C

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    End point title
    Percent change in HDL-C
    End point description
    Percent change in high-density lipoprotein cholesterol (HDL-C) after 12 weeks of treatment
    End point type
    Secondary
    End point timeframe
    After 12 weeks of treatment
    End point values
    rosuva 5 rosuva 10 rosuva 20 placebo
    Number of subjects analysed
    42
    44
    44
    46
    Units: percent change
        arithmetic mean (standard deviation)
    4.5 ± 15.53
    10.1 ± 14.19
    8.9 ± 14.11
    7.6 ± 17.89
    No statistical analyses for this end point

    Secondary: Percent change in Non-HDL-C at 12 weeks

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    End point title
    Percent change in Non-HDL-C at 12 weeks
    End point description
    Percent change in non-HDL-C at 12 weeks
    End point type
    Secondary
    End point timeframe
    After 12 weeks of treatment
    End point values
    rosuva 5 rosuva 10 rosuva 20 placebo
    Number of subjects analysed
    42
    44
    44
    46
    Units: percent change
        arithmetic mean (standard deviation)
    -36.3 ± 9.98
    -42.8 ± 11.5
    -47.7 ± 13.5
    -0.8 ± 11.89
    No statistical analyses for this end point

    Secondary: Percent change in triglycerides (TG)

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    End point title
    Percent change in triglycerides (TG)
    End point description
    Percent change in tryglycerides (TG) after 12 weeks of treatment
    End point type
    Secondary
    End point timeframe
    After 12 weeks of treatment
    End point values
    rosuva 5 rosuva 10 rosuva 20 placebo
    Number of subjects analysed
    42
    44
    44
    46
    Units: percent change
        arithmetic mean (standard deviation)
    2.6 ± 49.07
    -14.2 ± 29.66
    -7.9 ± 55.88
    3.4 ± 48.27
    No statistical analyses for this end point

    Secondary: Percent change in total cholesterol (TC)

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    End point title
    Percent change in total cholesterol (TC)
    End point description
    Percent change from baseline in total cholesteral after 12 weeks of treatment
    End point type
    Secondary
    End point timeframe
    After 12 weeks of treatment
    End point values
    rosuva 5 rosuva 10 rosuva 20 placebo
    Number of subjects analysed
    42
    44
    44
    46
    Units: percent change
        arithmetic mean (standard deviation)
    -30 ± 9.63
    -34.1 ± 9.5
    -38.9 ± 12.08
    0.2 ± 10.53
    No statistical analyses for this end point

    Secondary: Percent change in apolipoprotein A-1 (ApoA-1)

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    End point title
    Percent change in apolipoprotein A-1 (ApoA-1)
    End point description
    Percent change in ApoA-1 after 12 weeks of treatment
    End point type
    Secondary
    End point timeframe
    After 12 weeks of treatment
    End point values
    rosuva 5 rosuva 10 rosuva 20 placebo
    Number of subjects analysed
    42
    43
    43
    46
    Units: mean percent change
        arithmetic mean (standard deviation)
    2.3 ± 9.69
    4.3 ± 9.85
    3.9 ± 10.68
    3.6 ± 15.59
    No statistical analyses for this end point

    Secondary: Percent change in apolipoprotein B (ApoB)

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    End point title
    Percent change in apolipoprotein B (ApoB)
    End point description
    Percent change in ApoB after 12 weeks of treatment
    End point type
    Secondary
    End point timeframe
    After 12 weeks of treatment
    End point values
    rosuva 5 rosuva 10 rosuva 20 placebo
    Number of subjects analysed
    42
    43
    43
    46
    Units: mean percent change
        arithmetic mean (standard deviation)
    -32.1 ± 9.13
    -37.8 ± 11.75
    -40.7 ± 13.91
    -1.5 ± 14.67
    No statistical analyses for this end point

    Secondary: Percent change in ApoB/ApoA-1

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    End point title
    Percent change in ApoB/ApoA-1
    End point description
    Percent change in the ratio of ApoB/ApoA-1 after 12 weeks of treatment
    End point type
    Secondary
    End point timeframe
    After 12 weeks of treatment
    End point values
    rosuva 5 rosuva 10 rosuva 20 placebo
    Number of subjects analysed
    42
    43
    43
    46
    Units: mean percent change
        arithmetic mean (standard deviation)
    -33.1 ± 9.99
    -40 ± 12.06
    -42.8 ± 12.23
    -3.4 ± 16.7
    No statistical analyses for this end point

    Secondary: Percent change in LDL-C/HDL-C

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    End point title
    Percent change in LDL-C/HDL-C
    End point description
    Percent change in the ratio of LDL-C/HDL-C after 12 weeks of treatment
    End point type
    Secondary
    End point timeframe
    After 12 week of treatment
    End point values
    rosuva 5 rosuva 10 rosuva 20 placebo
    Number of subjects analysed
    42
    44
    44
    46
    Units: mean percent change
        arithmetic mean (standard deviation)
    -40.4 ± 11.36
    -48.6 ± 13.26
    -53.6 ± 12.85
    -5.5 ± 17.98
    No statistical analyses for this end point

    Secondary: Percent change in TC/HDL-C

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    End point title
    Percent change in TC/HDL-C
    End point description
    Percent change in the ratio of TC/HDL-C after 12 weeks of treatment
    End point type
    Secondary
    End point timeframe
    After 12 weeks of treatment
    End point values
    rosuva 5 rosuva 10 rosuva 20 placebo
    Number of subjects analysed
    42
    44
    44
    46
    Units: mean percent change
        arithmetic mean (standard deviation)
    -32.1 ± 10.72
    -39.3 ± 11.55
    -43.2 ± 11.76
    -5.2 ± 15.03
    No statistical analyses for this end point

    Secondary: Percent change in non-HDL-C/HDL-C

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    End point title
    Percent change in non-HDL-C/HDL-C
    End point description
    Percent change in the ratio of non-HDL-C/HDL-C after 12 weeks of treatment
    End point type
    Secondary
    End point timeframe
    After 12 weeks of treatment
    End point values
    rosuva 5 rosuva 10 rosuva 20 placebo
    Number of subjects analysed
    42
    44
    44
    46
    Units: mean percent change
        arithmetic mean (standard deviation)
    -37.9 ± 12.12
    -47.1 ± 13.12
    -51.2 ± 13.18
    -5.8 ± 17.63
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    From dietary lead-in period(week -1) to end of study(Week 52).
    Assessment type
    Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    MedDRA
    Dictionary version
    11.0
    Reporting groups
    Reporting group title
    rosuva 5
    Reporting group description
    rosuvastatin 5 mg

    Reporting group title
    rosuva 10
    Reporting group description
    rosuvastatin 10 mg

    Reporting group title
    rosuva 20
    Reporting group description
    rosuvastatin 20 mg

    Reporting group title
    placebo
    Reporting group description
    placebo

    Reporting group title
    rosuva ol
    Reporting group description
    rosuvastatin open label

    Serious adverse events
    rosuva 5 rosuva 10 rosuva 20 placebo rosuva ol
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 42 (0.00%)
    0 / 44 (0.00%)
    0 / 44 (0.00%)
    1 / 46 (2.17%)
    2 / 173 (1.16%)
         number of deaths (all causes)
    0
    0
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    0
    0
    Eye disorders
    Vision Blurred
    alternative dictionary used: MedDRA 11.0
         subjects affected / exposed
    0 / 42 (0.00%)
    0 / 44 (0.00%)
    0 / 44 (0.00%)
    1 / 46 (2.17%)
    0 / 173 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Skin and subcutaneous tissue disorders
    Rash Vesicular
    alternative dictionary used: MedDRA 11.0
         subjects affected / exposed
    0 / 42 (0.00%)
    0 / 44 (0.00%)
    0 / 44 (0.00%)
    0 / 46 (0.00%)
    1 / 173 (0.58%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    3 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    Appendicitis
    alternative dictionary used: MedDRA 11.0
         subjects affected / exposed
    0 / 42 (0.00%)
    0 / 44 (0.00%)
    0 / 44 (0.00%)
    0 / 46 (0.00%)
    1 / 173 (0.58%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    rosuva 5 rosuva 10 rosuva 20 placebo rosuva ol
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    12 / 42 (28.57%)
    14 / 44 (31.82%)
    17 / 44 (38.64%)
    17 / 46 (36.96%)
    75 / 173 (43.35%)
    Nervous system disorders
    Headache
    alternative dictionary used: MedDRA 11.0
         subjects affected / exposed
    6 / 42 (14.29%)
    7 / 44 (15.91%)
    9 / 44 (20.45%)
    9 / 46 (19.57%)
    29 / 173 (16.76%)
         occurrences all number
    6
    7
    9
    9
    29
    General disorders and administration site conditions
    Fatigue
    alternative dictionary used: MedDRA 11.0
         subjects affected / exposed
    1 / 42 (2.38%)
    1 / 44 (2.27%)
    1 / 44 (2.27%)
    0 / 46 (0.00%)
    9 / 173 (5.20%)
         occurrences all number
    1
    1
    1
    0
    9
    Gastrointestinal disorders
    Nausea
    alternative dictionary used: MedDRA 11.0
         subjects affected / exposed
    2 / 42 (4.76%)
    0 / 44 (0.00%)
    2 / 44 (4.55%)
    2 / 46 (4.35%)
    10 / 173 (5.78%)
         occurrences all number
    2
    0
    2
    2
    10
    Tonsillitis
    alternative dictionary used: MedDRA 11.0
         subjects affected / exposed
    0 / 42 (0.00%)
    0 / 44 (0.00%)
    3 / 44 (6.82%)
    1 / 46 (2.17%)
    2 / 173 (1.16%)
         occurrences all number
    0
    0
    3
    1
    2
    Infections and infestations
    Influenza
    alternative dictionary used: MedDRA 11.0
         subjects affected / exposed
    2 / 42 (4.76%)
    2 / 44 (4.55%)
    0 / 44 (0.00%)
    4 / 46 (8.70%)
    14 / 173 (8.09%)
         occurrences all number
    2
    2
    0
    4
    14
    Nasopharyngitis
    alternative dictionary used: MedDRA 11.0
         subjects affected / exposed
    3 / 42 (7.14%)
    7 / 44 (15.91%)
    7 / 44 (15.91%)
    5 / 46 (10.87%)
    36 / 173 (20.81%)
         occurrences all number
    3
    7
    7
    5
    36

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    Substantial protocol amendments (globally)

    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    08 Dec 2006
    Substudy is no longer a part of the main study
    08 Dec 2006
    HeHF definition: Definition expanded to provide guidance for LDL criteria in statin treated relatives
    08 Dec 2006
    Removed the text “in a first degree relative” in order to be consistent with the FDA Written.

    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
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