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    Summary
    EudraCT Number:2006-001716-71
    Sponsor's Protocol Code Number:RIMON_C_01346
    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:2006-12-29
    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 number2006-001716-71
    A.3Full title of the trial
    A RANDOMIZED, DOUBLE BLIND, TWO ARM, PARALLEL, PLACEBO CONTROLLED STUDY OF RIMONABANT 20MG EFFECT ON HIGH DENSITY LIPOPROTEIN KINETICS IN PATIENTS WITH ABDOMINAL OBESITY AND ADDITIONAL CARDIOMETABOLIC RISK FACTORS
    A.3.2Name or abbreviated title of the trial where available
    HDL TURNOVER
    A.4.1Sponsor's protocol code numberRIMON_C_01346
    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 Groupe
    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 Yes
    D.2.1.1.1Trade name Acomplia
    D.2.1.1.2Name of the Marketing Authorisation holdersanofi aventis
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    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 namerimonabant
    D.3.2Product code SR141716
    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 INNrimonabant
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number20
    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
    PATIENTS WITH ABDOMINAL OBESITY AND ADDITIONAL CARDIOMETABOLIC RISK FACTORS
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 8.1
    E.1.2Level LLT
    E.1.2Classification code 10059179
    E.1.2Term Abdominal obesity
    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 End-point is the fractional catabolic rate of ApoA-I in HDL after 12 months of treatment.
    E.2.2Secondary objectives of the trial
    - To assess effect of Rimonabant on HDL ApoA-I production rate (PR) and on other lipoprotein kinetics.
    - To assess effect of Rimonabant on lipids, glycemic and inflammatory parameters
    - To assess effect of Rimonabant on body composition
    - To assess safety of Rimonabant
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1) Informed consent must be obtained in writing for all patients at enrollment into the study
    2) Male or female 35-65 years of age
    3) Females must be post-menopausal (menopause is defined as 6 months of amenorrhea and plasma FSH > 20 U/L)
    4) BMI > 27 kg/m² and < 40 kg/m²
    5) Willingness and ability to comply with the study protocol
    6) Men or women with abdominal obesity according to NCEP/ATPIII criteria: Waist Circumference > 88 cm in women; > 102 cm in men.
    7) With at least one lipid abnormality defined as:
    - Fasting Triglycerides level >1.7 mmol/L (150 mg/dL) and < 4.5 mmol/L (400 mg/dL)
    - HDL < 1.03 mmol/L (40 mg/dL) in men and < 1.29 mmol/L (50 mg/dL) in women

    E.4Principal exclusion criteria
    1) HDL< or = 0.60 mmol/L (23 mg/dl)
    2) Plasma LDL-Cholesterol > 155 mg/dl (4.00 mmol/L) or total cholesterol 250 mg/dl (> 6.5mmol/L) or genetic hyperlipidaemia
    3) Fasting triglycerides > 400 mg/dL (4.5 mmol/L)
    4) Known heterozygous or homozygous familial hypercholesterolaemia or known type III hyperlipoproteinaemia (familial dysbetalipoproteinaemia)
    5) ApoE2/E2 homozygosity, Apo E4/E4 homozygosity
    6) Type 2 diabetes treated with oral agents and/or insulin
    7) Diet treated type 2 diabetic patients with HbA1c ≥ 7%
    8) History of cardio vascular disease (myocardial infarction, angina, stroke, confirmed peripheral arterial disease, coronary and peripheral vascular Surgery (CABG, PCI…)
    9) Systolic blood pressure ≥ 160 mm Hg or diastolic blood pressure ≥ 95 mm Hg
    10) Very low-calorie diet (1200 calories a day or less) or history of surgical procedures for weight loss (e.g., stomach stapling, bypass)
    11) Body weight fluctuation > 5 Kg during the previous 3 months
    12) History of bulimia or anorexia nervosa by DSM-IV criteria
    13) Presence of any clinically significant endocrine disease according to the investigator, Cushing syndrome, obesity secondary to hypothalamic/pituitary disorder
    14) Abnormal TSH and free T4 at baseline (Patients treated with thyroid replacement therapy must be on fixed and stable dose for at least 3 months prior to screening and must be in euthyroïd status)
    15) Severe hepatic impairment known by the investigator or AST or ALT > 3 times the ULN at screening. In this case, a second determination of hepatic tests will be performed after one week. If the dysfunction is confirmed, the patient must not be included in the study
    16) Known severe renal dysfunction (creatinine clearance < 30 ml/min) or urine analysis (performed at screening by dipstick) showing 2+ or more protein
    17) Presence of any condition (medical, including clinically significant abnormal laboratory test, psychological, social or geographical) actual or anticipated that the investigator feels would compromise the patient safety or limit his/her successful participation to the study:
    • Any current malignancy or any cancer within the past five years (except adequately treated basal cell skin cancer or cervical carcinoma in situ)
    • Any history of cardiac failure
    • Relevant acute abnormal finding seen on ECG
    • Significant haematology abnormalities (haemoglobin < 120 g/L and/or neutrophils < 1.5 G/L and/or platelets < 100 G/L)

    18) Patient treated for epilepsy
    19) Uncontrolled serious psychiatric illness such as a major depression
    20) History of alcohol and/or drug abuse
    21) Smoker or smoking cessation within the past 3 months
    22) Marijuana or hashish users
    23) Previous participation in a Rimonabant study or to any other clinical trial within 4 weeks to study start
    24) Hypersensitivity/intolerance to the active substance or to any of the excipients such as lactose
    25) Blood donation within the past 3 months prior to the study or planned during the study or within the 3 months from the study completing
    26) History of peptic ulcer
    27) Willebrand disease or other hemorrhagic diatheses

    Concomitant medications prior and during the study:
    28) Administration of any of the following within 3 months prior to screening visit and susceptible to be prescribed during the study treatment period:
    - Lipid-lowering drugs intake (statin, fibrate, bile acid sequestrant, ezetimibe, nicotinic acid)
    - Other drugs for weight reduction (phentermine, amphetamines)
    - Other drugs known to affect lipid metabolism
    29) Current use of antidepressants

    E.5 End points
    E.5.1Primary end point(s)
    The primary end point is the fractional catabolic rate (FCR) of ApoA-1 in HDL after 12 months of treatment.
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis Information not present in EudraCT
    E.6.2Prophylaxis Information not present in EudraCT
    E.6.3Therapy Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic Information not present in EudraCT
    E.6.8Bioequivalence Information not present in EudraCT
    E.6.9Dose response Information not present in EudraCT
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic Information not present in EudraCT
    E.6.12Pharmacoeconomic Information not present in EudraCT
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    Genetic analysis and lipoprotein kinetic
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) Information not present in EudraCT
    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) Information not present in EudraCT
    E.7.3Therapeutic confirmatory (Phase III) Yes
    E.7.4Therapeutic use (Phase IV) Information not present in EudraCT
    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 concerned2
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA4
    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 years2
    E.8.9.1In the Member State concerned months5
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months5
    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) 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 No
    F.3.3.1Women of childbearing potential not using contraception Information not present in EudraCT
    F.3.3.2Women of child-bearing potential using contraception Information not present in EudraCT
    F.3.3.3Pregnant women Information not present in EudraCT
    F.3.3.4Nursing women Information not present in EudraCT
    F.3.3.5Emergency situation Information not present in EudraCT
    F.3.3.6Subjects incapable of giving consent personally Information not present in EudraCT
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 64
    F.4.2.2In the whole clinical trial 80
    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 Decision2007-09-17
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2006-01-10
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2008-12-18
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