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    Summary
    EudraCT Number:2005-002942-20
    Sponsor's Protocol Code Number:EFC5826 -CRESCENDO
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2009-04-24
    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 ConcernedItaly - Italian Medicines Agency
    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 -CRESCENDO
    A.5.1ISRCTN (International Standard Randomised Controlled Trial) NumberND
    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-Synthelabo Recherche
    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.3.1Product namerimonabant
    D.3.2Product code SR141716
    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 INNrimonabant
    D.3.9.1CAS number 168273-06-01
    D.3.9.2Current sponsor codeSR141716 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 Yes
    D.3.11.13.1Other medicinal product typeNon Applicabile
    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
    Patients with abdominal obesity at increased risk for cardiovascular events (myocardial infarction, stroke and cardiovascular death)
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level LLT
    E.1.2Classification code 10003601
    E.1.2Term Atherosclerosis
    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
    FARMACOGENETICA: Versione: Data: Titolo:NESSUN CENTRO ITALIANO PARTECIPA Obiettivi:

    ALTRI SOTTOSTUDI: studio metabolico, studio dei biomarkers
    E.3Principal inclusion criteria
    1.Written informed consent obtained; 2. Men and women aged 55 or older; 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; 4. Presence of at least one coronary heart disease (CHD) risk equivalent OR two major cardiovascular risk factors Coronary heart disease risk equivalents (see par. 7.2 in the protocol): a) Recent (within the past 3 years)documented myocardial infarction (MI), b)Stable angina with documented multivessel coronary disease and/or history of multivessel percutaneous coronary intervention (PCI) or multivessel coronary artery bypass graft (CABG, c) Recent (within the past 3 years) cerebrovascular disease, as evidenced by an ischemic cerebrovascular episode, d)Documented symptomatic peripheral arterial disease (PAD), e)type 2 diabetes mellitus, 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 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): - Asymptomatic disease of the carotid, intracranial, and/or vertebral arteries, with greater than 50% stenosis - 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 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
    1. Obesity due to known endocrine disorder, such as hypothyroidism, or hypopituitary or other endocrine disease 2. Pregnant or breast-feeding women 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 or presence of any severe medical or psychological condition that, in the opinion of the Investigator, would compromise the patient’s safe participation 5- Clinically significant cardiovascular disease that, in the opinion of the investigator, is likely to require intervention invasive ( 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 No
    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 concerned20
    E.8.5The trial involves multiple Member States Yes
    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 years4
    E.8.9.1In the Member State concerned months2
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years4
    E.8.9.2In all countries concerned by the trial months2
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    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) No
    F.1.1.6Adolescents (12-17 years) No
    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 For clinical trials recorded in the database before the 10th March 2011 this question read: "Women of childbearing potential" and did not include the words "not using contraception". An answer of yes could have included women of child bearing potential whether or not they would be using contraception. The answer should therefore be understood in that context. This trial was recorded in the database on 2009-04-24. Yes
    F.3.3.2Women of child-bearing potential using contraception Information not present in EudraCT
    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 state650
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 5000
    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 Decision2006-03-16
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2006-01-20
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2009-04-17
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