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    Summary
    EudraCT Number:2008-002849-23
    Sponsor's Protocol Code Number:EFC10841
    National Competent Authority:France - ANSM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2008-10-21
    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 ConcernedFrance - ANSM
    A.2EudraCT number2008-002849-23
    A.3Full title of the trial
    A multicenter, double-blind, randomized, placebo-controlled study to evaluate the efficacy, safety and tolerability of AVE5530 when added to ongoing stable statin therapy at high doses in patients with severe primary hypercholesterolemia
    A.4.1Sponsor's protocol code numberEFC10841
    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 SponsorSanofi-Aventis Recherche & Développement
    B.1.3.4CountryFrance
    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 No
    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.3.2Product code AVE5530
    D.3.4Pharmaceutical form Film-coated 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 INNcanosimibe
    D.3.9.1CAS number 768394-99-6
    D.3.9.2Current sponsor codeAVE5530
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number25
    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.IMP: 2
    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 No
    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.3.2Product code AVE5530
    D.3.4Pharmaceutical form Film-coated 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 INNcanosimibe
    D.3.9.1CAS number 768394-99-6
    D.3.9.2Current sponsor codeAVE5530
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number50
    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 placeboFilm-coated tablet
    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
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 11.0
    E.1.2Level LLT
    E.1.2Classification code 10060375
    E.1.2Term <Manually entered code. Term in E.1.1>
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    • The primary objective of this study is to assess the efficacy over 12 weeks (3 months) of AVE5530 25 mg and 50 mg as add-on therapy to ongoing stable high-dose statin on calculated LDL-C levels in comparison with placebo (ie statin alone) in patients with primary severe hypercholesterolemia.

    • Additional evaluations of LDL-C will be performed at week 12:
    − Percent change from baseline in LDL-C measured by ultracentrifugation
    − Proportion of patients achieving NCEP-ATPIII target goals for calculated LDL-C.
    E.2.2Secondary objectives of the trial
    The secondary objectives of this study are as follows:
    • To assess the effects of AVE5530 25 mg/day and AVE5530 50 mg/day in comparison with placebo over 12 weeks in add-on therapy to ongoing stable high-dose statin on
    − Total-Cholesterol (Total-C) and
    − Apolipoprotein B (Apo-B) levels

    • To assess the safety and tolerability of AVE5530 25 mg/day and AVE5530 50 mg/day
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Patients can be included only if they satisfy the following criteria:
    • With severe primary hypercholesterolemia and confirmed insufficient control with ongoing atorvastatin or simvastatin or rosuvastatin treatment at the highest doses (80 mg, 80 mg or 40 mg respectively) for at least 6 weeks
    • With written informed consent obtained.
    E.4Principal exclusion criteria
    Exclusion criteria related to study methodology:
    • Age less than 18 years at Visit 1
    • Administration of other investigational drugs within 30 days or 5 half lives prior to Visit 1 (whichever is the longest)
    • Patient who previously participated in another AVE5530 trial
    • Patient who will require, in addition to ongoing atorvastatin, simvastatin or rosuvastatin treatment at the highest doses (80 mg, 80 mg or 40 mg respectively), another lipid-lowering agent (other than the study medication) in the near future, based on investigator’s judgment
    • Patient in whom adjustment of the ongoing lipid lowering therapy as per protocol requirement would not be appropriate based on investigator’s judgment or who is not willing to undergo therapy adjustment
    • LDL-C levels < 100 mg/dL (2.59 mmol/L)
    • LDL-C levels > 250 mg/dL (6.48 mmol/L)
    • Triglycerides > 350 mg/dL (3.95 mmol/L)
    • Known homozygous familial hypercholesterolemia
    • Conditions / situations such as:
    − Patients with conditions/concomitant diseases
    − Making them non-evaluable for the primary efficacy endpoint: such as presence of any clinically significant and not controlled endocrine disease known to influence serum lipids or lipoproteins. Patients on thyroid replacement therapy can be included if the dosage of thyroxine has been stable for at least 3 months prior to Visit 1 and their s- TSH (sensitive TSH) levels is within ±10% of the normal ranges of the Central
    Laboratory.
    − Any conditions considered to be medically sound by the investigator that would limit the patient’s safe participation in the study such as:
    - Active liver disease, as shown by but not limited to alanine aminotransferase
    (ALT) or aspartate amino-transferase (AST) ≥ 3xUpper Limit Normal (ULN) range
    - Neutrophils < 1,500/mm3
    - Platelets counts < 100 000/ mm3
    - Unexplained CPK ≥ 3xULN
    - Recent history (within 6 months of Visit 1 and through to randomization) of
    moderate or severe congestive heart failure [New York Heart Association (NYHA)Class III or IV]
    - Recent history of unstable angina pectoris, myocardial infarction, coronary bypass surgery or angioplasty within 6 months of study screening,
    - Unstable or severe peripheral artery disease within 6 months of Visit 1 and through to randomization
    - Positive test for Hepatitis B surface antigen and/or Hepatitis C antibody
    - Known to be Human Immunodeficiency Virus (HIV) positive
    − Presence of any other conditions (e.g. geographic, social….) actual or anticipated that the investigator feels would restrict or limit the patient’s participation for the duration of the study
    − Patient is the Investigator or any Sub-Investigator, research assistant, pharmacist, study coordinator, other staff or relative thereof directly involved in the conduct of the protocol.
    − Administration of any lipid-lowering treatment other than the background statins allowed for the study (atorvastatin 80 mg, simvastatin 80 mg or rosuvastatin 40 mg)
    after visit 1.

    Exclusion criteria related to AVE5530 compound:
    • Pregnant or breast-feeding women,
    • Women of childbearing potential not protected by effective method of birth control (including oral contraceptives) and/or who are unwilling or unable to be tested for pregnancy prior to exposure to the Investigational Product.
    E.5 End points
    E.5.1Primary end point(s)
    Efficacy
    • The primary efficacy endpoint is the percent change from baseline to 12 weeks (3 months) in calculated Low Density Lipoprotein –Cholesterol (LDL-C) serum levels
    • Additional evaluations of LDL-C at week 12 are:
    − Percent change from baseline to 12 weeks in LDL-C measured by ultracentrifugation
    − Proportion of patients achieving NCEP-ATPIII target goals for calculated LDL-C at 12 weeks.
    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 Information not present in EudraCT
    E.7.1.2Bioequivalence study Information not present in EudraCT
    E.7.1.3Other Information not present in EudraCT
    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 No
    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 Yes
    E.8.4.1Number of sites anticipated in Member State concerned4
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA32
    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 No
    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 years
    E.8.9.1In the Member State concerned months18
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial months18
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero Information not present in EudraCT
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) Information not present in EudraCT
    F.1.1.3Newborns (0-27 days) Information not present in EudraCT
    F.1.1.4Infants and toddlers (28 days-23 months) Information not present in EudraCT
    F.1.1.5Children (2-11years) Information not present in EudraCT
    F.1.1.6Adolescents (12-17 years) Information not present in EudraCT
    F.1.2Adults (18-64 years) Yes
    F.1.3Elderly (>=65 years) Yes
    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 No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state30
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 219
    F.4.2.2In the whole clinical trial 668
    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 Decision2008-11-27
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2008-12-12
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2009-06-05
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    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
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