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    Summary
    EudraCT Number:2008-006271-70
    Sponsor's Protocol Code Number:P05522
    National Competent Authority:Greece - EOF
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2011-01-11
    Trial results View results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedGreece - EOF
    A.2EudraCT number2008-006271-70
    A.3Full title of the trial
    A Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Efficacy and Safety Study of Ezetimibe Monotherapy in Children (Ages 6 to 10 Years) With Primary Hypercholesterolemia (Heterozygous Familial and Nonfamilial)
    A.4.1Sponsor's protocol code numberP05522
    A.7Trial is part of a Paediatric Investigation Plan Information not present in EudraCT
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorSchering-Plough Research Institute, A Division of Schering Corporation,
    B.1.3.4CountryUnited States
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing support
    B.4.2Country
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisation
    B.5.2Functional name of contact point
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.1.1Trade name Ezetrol
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameEzetimibe
    D.3.4Pharmaceutical form Tablet
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNEzetimibe
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number10
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) Information not present in EudraCT
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product Information not present in EudraCT
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboTablet
    D.8.4Route of administration of the placeboOral use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    -Primary Hypercholesterolemia (Heterozygous Familial [HeFH])
    -Primary Hypercholesterolemia (Nonfamilial)
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level LLT
    E.1.2Classification code 10057079
    E.1.2Term Heterozygous familial hypercholesterolemia
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level LLT
    E.1.2Classification code 10020604
    E.1.2Term Hypercholesterolemia
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Determine the effect of ezetimibe 10mg/day compared to placebo on the reduction of LDL-C from baseline to 12 weeks of treatment in children ≥6 to ≤10 years old with primary hypercholesterolemia (HeFH and nonfamilial)
    E.2.2Secondary objectives of the trial
    Key secondary objective: Determine effect of ezetimibe 10mg/day compared to placebo on TC, Apo B, HDL-C, non-HDL-C, & TG from baseline (BL) to 12 weeks of treatment

    Other secondary objectives:
    Determine effect of ezetimibe 10mg/day compared to placebo on:
    -LDL-C, TC, HDL-C, non-HDL-C, TG, and ratios LDL-C:HDL-C and TC:HDL-C from baseline to 2, 4 and 8 weeks of treatment
    -apolipoprotein A1 (Apo A1), and ratios of LDL-C:HDL-C, TC:HDL-C, and Apo B: Apo A1 from baseline to 12 weeks of treatment
    -Plasma hs-CRP from BL to 4 & 12 weeks of treatment
    -Plasma plant sterols/stanols, sitosterol, campesterol, and cholestanol & lathosterol from BL to 2, 4, 8, & 12 weeks of treatment

    Determine safety of ezetimibe 10 mg/day as assessed by AEs, physical examinations, lab parameters (chemistry, hematology, urinalysis, & steroid hormone levels), & effects on liver and muscle
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    A PK substudy will be conducted in a subset of patients to explore and provide a
    descriptive analysis of the PK profile of ezetimibe in this population.

    Full title, date & version of sub-study: N/A

    Other Secondary Objective: To assess the PK parameters & to provide a descriptive analysis of ezetimibe 10 mg/day in a subset of study participants.
    E.3Principal inclusion criteria
    1. Each subject may be of either sex and of any race/ethnicity, and must be ≥6 and ≤10 years of age, with a diagnosis of primary hypercholesterolemia (heterozygous familial or nonfamilial) despite being on a lipid-lowering diet for at least 3 months

    2. Any subject meeting at least one of the following clinical criteria items, a-e
    below, will be considered to have heterozygous familial hypercholesterolemia:
    a. genotype-confirmed HeFH with written documentation of the genetic diagnosis prior to or at the time of screening & LDL-C >159 mg/dL(4.12 mmol/L) & <400 mg/dL (10.36 mmol/L)
    b. LDL-C >159 mg/dL (4.12 mmol/L) & <400 mg/dL (10.36 mmol/L) with at least one biological parent with genotype-confirmed HeFH & a historical untreated LDL-C of >159 mg/dL
    c. LDL-C >159 mg/dL (4.12 mmol/L) & <400 mg/dL (10.36 mmol/L) with at least one biological parent with an untreated LDL-C value of at least 210 mg/dL (5.44 mmol/L) not associated with a disorder known to produce secondary elevation of LDL-C
    d. LDL-C >159 mg/dL (4.12 mmol/L) & <400 mg/dL (10.36 mmol/L) with tendinous xanthomas, not associated with a disorder known to produce secondary elevation of LDL-C
    e. LDL-C >189 mg/dL (4.90 mmol/L) & <400 mg/dL (10.36 mmol/L) & a family history of hypercholesterolemia consistent with dominant autosomal transmission

    3. Each subject with nonfamilial primary hypercholesterolemia must have a LDL-C of > 159mg/dL (4.12 mmol/L) and < 400mg/dL (10.36 mmol/L) at Visit 3

    4. Each subject must have been on a diet in accordance with the American Heart Association/American Academy of Pediatric guidelines

    5. Each subject’s complete blood count [CBC], blood chemistry, urinalysis, & steroid hormone levels must be within normal limits or clinically acceptable to the investigator

    6. Each subject must be free of any clinically significant disease, other than hypercholesterolemia, that would interfere with the study evaluations

    7. Each subject must be willing to participate in the study & to complete all study-related procedures

    8. Each subject’s parent/guardian must be willing to give written informed consent on his/her behalf

    9. Each subject must be able to adhere to dosing requirements & visit schedules

    10. All females of child-bearing potential must have a negative serum pregnancy test (beta-hCG) at screening
    E.4Principal exclusion criteria
    Each subject must not:
    1. have known hypersensitivity or any contraindication to ezetimibe
    2. have a height below the 3rd percentile for age & sex (using accepted standards)
    3. be in a situation or have any condition that, in the opinion of the investigator, may interfere with optimal participation in the study
    4. have an underlying disease likely to limit life span to less than 1 year
    5. have use of any investigational drugs within 30 days of study entry
    6. have participation in any other clinical study, unless permission is given by this sponsor
    7. be a member or a family member of the personnel of the investigational or sponsor staff directly involved with this trial
    8. be a female of child-bearing potential who is pregnant, intends to become pregnant, or is nursing
    9. be a female of child-bearing potential who will not abstain from sex or use a medically acceptable method of birth control in the opinion of the investigator

    Exclusionary Concomitant Illness:
    Each subject must not:
    1. have known congenital cardiac disorder
    2. have any cardiac disorder that may limit participation in the study
    3. have documented or laboratory values consistent with homozygous familial hypercholesterolemia (HoFH)
    4. have disorders of the hematologic, digestive, or central nervous systems including cerebrovascular disease, anorexia nervosa, & degenerative disease that would limit study evaluation or participation
    5. have Type 1 diabetes mellitus
    6. have Type 2 diabetes mellitus
    7. have uncontrolled endocrine or metabolic disease known to influence serum lipids or lipoproteins
    8. be on unstable thyroid hormone replacement therapy with TSH levels outside the normal range
    9. have known clinically significant impairment of renal function, dysproteinemia, nephrotic syndrome, or other renal disease
    10. have fasting serum triglyceride that is >300 mg/dL (>3.39 mmol/L) at Visit 3
    11. have serum creatinine ≥ 2.0 mg/dL
    12. have active or chronic hepatic or biliary disease
    13. have AST and/or ALT >1.5 times the upper limit of normal (ULN) of the central laboratory reference range
    14. have blood creatine phosphokinase or creatine kinase (CPK) >1.5 times the ULN of the central laboratory reference range
    15. be known to be HIV positive
    16. have known coagulopathy
    17. be undergoing LDL apheresis or plasma apheresis
    18. have a history of a partial ileal bypass or disease that affects significant function of ileum
    19. have a history of mental instability, or be an individual who has been treated, or is being treated, for severe psychiatric illness that, in the opinion of the investigator, may interfere with optimal participation in the study
    E.5 End points
    E.5.1Primary end point(s)
    The percent change from baseline in LDL-C to 12 weeks in the ezetimibe group compared to the placebo group.
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind Yes
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group Yes
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo Yes
    E.8.2.3Other No
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned No
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA8
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA Information not present in EudraCT
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    E.8.7Trial has a data monitoring committee Yes
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months0
    E.8.9.2In all countries concerned by the trial days0
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 Yes
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) Yes
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) No
    F.1.3Elderly (>=65 years) No
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations Yes
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Yes
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    Conducted in children 6 to 10 years of age, inclusive (subjects must be willing to participate) and parent/guardian must be willing to give written informed consent on subject's behalf
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state60
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 70
    F.4.2.2In the whole clinical trial 135
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2011-01-24
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2011-03-15
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2012-04-13
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