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    Summary
    EudraCT Number:2005-002942-20
    Sponsor's Protocol Code Number:EFC5826
    National Competent Authority:Belgium - FPS Health-DGM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2005-12-09
    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 ConcernedBelgium - FPS Health-DGM
    A.2EudraCT number2005-002942-20
    A.3Full title of the trial
    Randomized, multinational, multicenter, double-blind, placebo-controlled, two-arm parallel group trial of rimonabant 20 mg OD for reducing the risk of major cardiovascular events in abdominally obese patients with clustering risk factors
    A.3.2Name or abbreviated title of the trial where available
    CRESCENDO
    A.4.1Sponsor's protocol code numberEFC5826
    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 et developpement
    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 SSR141716
    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.3.9.1CAS number 168273-06-01
    D.3.9.2Current sponsor codeSSR141716 form 2
    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 at increased risk for cardiovascular events (myocardial infarctio, stroke and cardiovascular death)
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 10.1
    E.1.2Level LLT
    E.1.2Classification code 10051615
    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
    To demonstrate the efficacy of rimonabant versus placebo for reducing the risk of myocardial infarction, stroke, or cardiovascular death in patients with abdominal obesity at increased risk for such events.
    E.2.2Secondary objectives of the trial
    To demonstrate the efficacy of rimonabant versus placebo for reducing the risk of myocardial infarction, stroke, cardiovascular death, or hospitalization for cardiovascular cause (unstable angina, transient ischemic attack, cardiac rhythm disorder, congestive heart failure, syncope, or urgent revascularization procedure), in patients with abdominal obesity at increased risk for such events.
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    1/ Substudy of CRESCENDO Study number EFC5826: CRESCENDO - Metabolic Substudy - version 1 dated 19 August 2005
    Objective: To evaluate the effect of rimonabant 20 mg OD on fasting HDL cholesterol, fasting LDL-cholesterol, fasting triglyceride, fasting plasma glucose, fasting insulin, and fasting HbA1c levels.

    2/Substudy of CRESCENDO Study number EFC5826: CRESCENDO - Biomarker Substudy - version 1 dated 19 August 2005
    Objective: To evaluate the effect of rimonabant 20 mg OD on hs-CRP, sCD40L, IL-6, PAI-1, sVCAM-1, P-selectin, myeloperoxidase, adiponectin, resistin, leptin, omentin, osteonectin, and visfatin.

    3/Substudy of CRESCENDO Study number EFC5826: CRESCENDO - Genomic Blood Sample Substudy - version 1 dated 11 July 2005
    Objective: The primary objective of the CRESCENDO Genomics Blood Sample Substudy is to collect blood samples that may be used for future hypothesis generating and hypothesis testing research from subjects enrolled in CRESCENDO Protocol Study Number EFC5826.
    Research that may be conducted on samples collected from this protocol or in combination with samples from other protocols can explore:
    - how variations in genes associate with clinical outcomes, eg, drug metabolizing enzyme variants with either pharmacokinetic endpoints or other clinical responses;
    - the associations among genetic variation, gene expression, and proteins and clinical conditions, such as obesity or metabolic disorders, and outcomes, such as MI, stroke, or cardiovascular death.

    4/Substudy of CRESCENDO Study number EFC5826: CRESCENDO - Microalbuminuria Substudy - version 1 dated 12 December 2007
    Objective: To evaluate the effect of rimonabant 20 mg OD on microalbuminuria in type 2 diabetes mellitus patients enrolled in CRESCENDO.
    E.3Principal inclusion criteria
    1. Written informed consent obtained
    2. Men and women aged 55 or older, AND
    3. Presence of abdominal obesity, with a waist circumference greater than 102 cm (40 inches) for males and greater than 88 cm (35 inches) for females on three
    successive measurements at the baseline visit, AND
    4. Presence of at least one coronary heart disease (CHD) risk equivalent OR two major cardiovascular risk factors

    Coronary heart disease risk equivalents:

    a) Recent (within the past 3 years) myocardial infarction (MI) (two of the following three criteria must be satisfied):
    • Characteristic ischemic chest pain or pain in associated referral areas or anginal equivalent symptoms,
    • Elevation of CK (at least twice the upper limit of normal values for that laboratory) and/or CK-MB (at least twice the upper limit of normal values for the laboratory) and/or troponin T or I (at least above the upper limit of normal for the laboratory),
    • Development of Q waves in at least two adjacent ECG leads, or development of a new dominant R wave in V1.

    b) Stable angina with documented multivessel coronary disease (defined as greater than 50% stenosis in at least two epicardial coronary arteries at angiography), and/or history of multivessel percutaneous coronary intervention (PCI) or multivessel coronary artery bypass graft (CABG) TOGETHER WITH at least one of the three following criteria:
    • Current exercise-induced angina pectoris
    • Positive ECG stress test (ST depression greater than 2 mm with normal baseline ST segments)
    • Reversible defect by myocardial perfusion imaging or stress-induced wall motion abnormality on stress echocardiography test

    c) Recent (within the past 3 years) cerebrovascular disease, as evidenced by an
    ischemic cerebrovascular episode (all criteria must be satisfied):
    • A focal neurological deficit
    • Without evidence of a cardio-embolic origin
    • Without evidence of non-vascular origin on CT or MRI scan CT or MRI must have been performed to document whether there is a lesion and to rule-out non-ischemic neurological disease.

    d) Documented symptomatic peripheral arterial disease (PAD) (one of the following primary criteria must be satisfied):
    • current intermittent claudication (WHO criteria, eg, leg pain occurring only while walking and disappearing in less than 10 minutes on standing) of presumed atherosclerotic origin TOGETHER WITH ankle-brachial index equal to or less than 0.85
    in either leg at rest,
    OR
    • history of intermittent claudication (WHO criteria as above) TOGETHER WITH either previous intervention by amputation, or reconstructive vascular surgery, or angioplasty in one or both legs because of atherosclerotic disease,


    Major cardiovascular risk factors:

    e) Type 2 diabetes mellitus (fasting plasma or serum glucose equal to or greater than 126 mg/dL [7.0 mmol/L] on two or more occasions)

    f) Metabolic syndrome, as diagnosed by the presence of at least 2 of the following risk factors (if 3 of the risk factors listed below are fulfilled, this is equivalent to two major risk factors and the patient is eligible):
    o Fasting triglyceride level equal to or greater than 150 mg/dL (1.69 mmol/L)
    o HDL-cholesterol less than 40 mg/dL (1.03 mmol/L) for males or less than 50 mg/dL (1.28 mmol/L) for females
    o Fasting plasma or serum glucose equal to or greater than 110 mg/dL (6.1 mmol/L)
    o Blood pressure equal to or greater than 130 mm Hg systolic and/or 85 mm Hg diastolic at baseline visit

    g) Cerebrovascular disease (at least one of the following three criteria must be
    satisfied):
    o Asymptomatic disease of the carotid, intracranial, and/or vertebral arteries, with greater than 50% stenosis
    o At least one carotid plaque on ultrasonography, defined as a distinct area with an intima-media thickness (IMT) exceeding twice that of neighboring sites,
    OR
    o Prior cerebrovascular revascularization procedure

    h) Renal artery disease, with greater than 60% stenosis on MR angiography, CT
    angiography, or angiography, or prior revascularization procedure

    i) Previous history of abdominal aortic aneurysm repair

    j) Asymptomatic ankle-brachial index less than 0.85

    k) Elevated hs-CRP greater than 3 mg/L

    l) Males 65 years or older or females 70 years or older
    E.4Principal exclusion criteria
    Related to general patient characteristics
    1. Obesity due to known endocrine disorder, such as hypothyroidism, or hypopituitary or other endocrine disease

    2. Pregnant or breast-feeding women, or women planning to become pregnant or to
    breast feed

    3. Very low-calorie diet (1200 calories a day or less) or surgical procedure for weight
    loss (eg, stomach stapling, bypass, etc) within 6 months prior to baseline visit

    4. Presence of any severe medical condition or advanced age such that the patient is not expected to survive for the planned study follow-up period

    5. Presence of any severe medical or psychological condition that, in the opinion of the Investigator, would compromise the patient’s safe participation, including uncontrolled serious psychiatric illness such as major depression, suicidal ideation, and medical history of suicide attempt

    6. Presence of any condition (medical, psychological, social, or geographical), actual or anticipated, that the Investigator feels would restrict or limit the patient’s successful participation for the duration of the study

    7. Receipt of any investigational treatment (drug or device) within 30 days prior to
    baseline visit

    8. Previous participation in a rimonabant study

    9. Known allergy to rimonabant or excipients

    Related to cardiovascular condition

    10. Clinically significant cardiovascular disease that, in the opinion of the investigator, is likely to require intervention (PCI, CABG, valve repair/replacement, heart transplantation, PTA, peripheral bypass surgery, endarterectomy, etc) within the next one month after randomization
    E.5 End points
    E.5.1Primary end point(s)
    The first occurrence of any component of the following cluster, as adjudicated by the
    Clinical Events Committee:
    • Any MI (nonfatal or fatal)
    • Any stroke (nonfatal or fatal)
    • Cardiovascular death
    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 No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic Yes
    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 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 concerned25
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA1000
    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 years
    E.8.9.1In the Member State concerned months50
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial months50
    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 state620
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 6640
    F.4.2.2In the whole clinical trial 17000
    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 Decision2006-01-09
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2006-03-23
    P. End of Trial
    P.End of Trial StatusCompleted
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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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