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CRESCENDO: Comprehensive Rimonabant Evaluation Study of Cardiovascular ENDpoints and Outcomes

Sponsor
Sanofi (Industry)
Overall Status
Terminated
CT.gov ID
NCT00263042
Collaborator
(none)
18,695
Enrollment
43
Locations
2
Arms
40
Duration (Months)
434.8
Patients Per Site
10.9
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The primary objective is to show whether rimonabant reduces the risk of a heart attack (MI), stroke, or death from an MI or stroke in patients with abdominal obesity with other cardiovascular (CV) risk factors.

The secondary objective is to show whether rimonabant reduces the risk of MI, stroke, CV death, or CV hospitalization in these patients.

Condition or Disease Intervention/Treatment Phase
Phase 3

Detailed Description

The estimated study duration per patient is 36 to 53 months. All patients will be followed from randomization until a common study end date, which will occur when the last patient has been followed for 33 months.

Study Design

Study Type:
Interventional
Actual Enrollment :
18695 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
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
Study Start Date :
Dec 1, 2005
Actual Primary Completion Date :
Apr 1, 2009
Actual Study Completion Date :
Apr 1, 2009

Arms and Interventions

Arm Intervention/Treatment
Experimental: Rimonabant

Rimonabant 20 mg once daily

Drug: Rimonabant
Tablet, oral administration
Other Names:
  • SR141716
  • Acomplia

    		•
    Placebo Comparator: Placebo

    Placebo (for Rimonabant) once daily.

    Drug: Placebo (for Rimonabant)
    Tablet, oral administration

    Outcome Measures

    Primary Outcome Measures

    1. First occurrence of any of myocardial infarction, stroke or cardiovascular (CV) death [From randomization up to common study end date (33-50 months)]

    Secondary Outcome Measures

    1. First occurrence of any of myocardial infarction, stroke, CV death, and CV hospitalization [From randomization up to common study end date (33-50 months)]

    2. All-cause mortality [From randomization up to common study end date (33-50 months)]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    55 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    Waist circumference >102 cm (40 inches) males, >88 cm (35 inches) females, with one coronary heart disease (CHD) equivalent or two major risk factors for cardiovascular disease.

    • CHD equivalents:

    • Recent (within 3 years)documented heart attack

    • Documented symptomatic coronary artery disease

    • Recent (within 3 years) ischemic cerebrovascular episode (stroke or TIA)

    • Documented symptomatic peripheral arterial disease

    • Major risk factors:

    • Documented type 2 diabetes mellitus

    • Metabolic syndrome (NCEP criteria)

    • Asymptomatic cerebrovascular, renal, or peripheral arterial disease, or past abdominal aortic aneurysm repair

    • Elevated high-sensitivity C-reactive protein

    • Age > or = 65 years for males, age > or = 70 years for females

    Exclusion Criteria:

    • Obesity of known endocrine origin

    • Pregnant or breastfeeding women

    • Very low calorie diet or weight loss surgery within past 6 months

    • 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

    • Likely cardiovascular intervention within next 1 month

    • Allergy to rimonabant or excipients, or prior participation in a rimonabant trial

    • Receipt of investigational product within past 30 days

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Sanofi-Aventis Administrative Office Bridgewater New Jersey United States 08807
    2 Sanofi-Aventis Administrative Office Buenos Aires Argentina
    3 sanofi-aventis Australia & New Zealand administrative office Macquarie Park New South Wales Australia
    4 Sanofi-Aventis Administrative Office Vienna Austria
    5 Sanofi-Aventis Administrative Office Diegem Belgium
    6 Sanofi-Aventis Administrative Office Sao Paulo Brazil
    7 Sanofi-Aventis Administrative Office Laval Quebec Canada
    8 Sanofi-Aventis Administrative Office Santiago de Chile Chile
    9 Sanofi-Aventis Administrative Office Shangaï China
    10 Sanofi-Aventis Administrative Office Santafe de Bogota Colombia
    11 Sanofi-Aventis Administrative Office Praha Czech Republic
    12 Sanofi-Aventis Administrative Office Horsholm Denmark
    13 Sanofi-Aventis Administrative Office Helsinki Finland
    14 Sanofi-Aventis Administrative Office Paris France
    15 Sanofi-Aventis Administrative Office Berlin Germany
    16 Sanofi-Aventis Administrative Office Athens Greece
    17 Sanofi-Aventis Administrative Office Hong-Kong Hong Kong
    18 Sanofi-Aventis Administrative Office Budapest Hungary
    19 Sanofi-Aventis Administrative Office Mumbai India
    20 Sanofi-Aventis Administrative Office Dublin Ireland
    21 Sanofi-Aventis Administrative Office Natanya Israel
    22 Sanofi-Aventis Administrative Office Milano Italy
    23 Sanofi-Aventis Administrative Office Seoul Korea, Republic of
    24 Sanofi-Aventis Administrative Office Kuala Lumpur Malaysia
    25 Sanofi-Aventis Administrative Office Mexico Mexico
    26 Sanofi-Aventis Administrative Office Gouda Netherlands
    27 Sanofi-Aventis Administrative Office Lysaker Norway
    28 Sanofi-Aventis Administrative Office Lima Peru
    29 Sanofi-Aventis Administrative Office Makati City Philippines
    30 Sanofi-Aventis Administrative Office Warszawa Poland
    31 Sanofi-Aventis Administrative Office Porto Salvo Portugal
    32 Sanofi-Aventis Administrative Office Bucuresti Romania
    33 Sanofi-Aventis Administrative Office Moscow Russian Federation
    34 Sanofi-Aventis Administrative Office Singapore Singapore
    35 Sanofi-Aventis Administrative Office Midrand South Africa
    36 Sanofi-Aventis Administrative Office Madrid Spain
    37 Sanofi-Aventis Administrative Office Bromma Sweden
    38 Sanofi-Aventis Administrative Office Geneva Switzerland
    39 Sanofi-Aventis Administrative Office Taipei Taiwan
    40 Sanofi-Aventis Administrative Office Bangkok Thailand
    41 Sanofi-Aventis Administrative Office Megrine Tunisia
    42 Sanofi-Aventis Administrative Office Istanbul Turkey
    43 Sanofi-Aventis Administrative Office Guildford United Kingdom

    Sponsors and Collaborators

    • Sanofi

    Investigators

    • Study Chair: Eric Topol, MD, Scripps Clinic
    • Principal Investigator: Deepak L. Bhatt, MD, The Cleveland Clinic

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Sanofi
    ClinicalTrials.gov Identifier:
    NCT00263042
    Other Study ID Numbers:
    • EFC5826
    • 2005-002942-20
    First Posted:
    Dec 7, 2005
    Last Update Posted:
    May 20, 2016
    Last Verified:
    Apr 1, 2016
    Keywords provided by Sanofi
    Myocardial infarction
    cerebrovascular accident
    obesity
    Additional relevant MeSH terms:
    Cardiovascular Diseases
    Rimonabant

    Study Results

    No Results Posted as of May 20, 2016