Comprehensive Rimonabant Evaluation Study of Cardiovascular ENDpoints and Outcomes
NCT ID: NCT00263042
Last Updated: 2016-05-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE3
18695 participants
INTERVENTIONAL
2005-12-31
2009-04-30
Brief Summary
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The secondary objective is to show whether rimonabant reduces the risk of MI, stroke, CV death, or CV hospitalization in these patients.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Rimonabant
Rimonabant 20 mg once daily
Rimonabant
Tablet, oral administration
Placebo
Placebo (for Rimonabant) once daily.
Placebo (for Rimonabant)
Tablet, oral administration
Interventions
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Rimonabant
Tablet, oral administration
Placebo (for Rimonabant)
Tablet, oral administration
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
55 Years
ALL
No
Sponsors
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Sanofi
INDUSTRY
Responsible Party
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Principal Investigators
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Eric Topol, MD
Role: STUDY_CHAIR
Scripps Clinic
Deepak L. Bhatt, MD
Role: PRINCIPAL_INVESTIGATOR
The Cleveland Clinic
Locations
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Sanofi-Aventis Administrative Office
Bridgewater, New Jersey, United States
Sanofi-Aventis Administrative Office
Buenos Aires, , Argentina
sanofi-aventis Australia & New Zealand administrative office
Macquarie Park, New South Wales, Australia
Sanofi-Aventis Administrative Office
Vienna, , Austria
Sanofi-Aventis Administrative Office
Diegem, , Belgium
Sanofi-Aventis Administrative Office
São Paulo, , Brazil
Sanofi-Aventis Administrative Office
Laval, Quebec, Canada
Sanofi-Aventis Administrative Office
Santiago, , Chile
Sanofi-Aventis Administrative Office
Shangaï, , China
Sanofi-Aventis Administrative Office
Bogotá, , Colombia
Sanofi-Aventis Administrative Office
Prague, , Czechia
Sanofi-Aventis Administrative Office
Hørsholm, , Denmark
Sanofi-Aventis Administrative Office
Helsinki, , Finland
Sanofi-Aventis Administrative Office
Paris, , France
Sanofi-Aventis Administrative Office
Berlin, , Germany
Sanofi-Aventis Administrative Office
Athens, , Greece
Sanofi-Aventis Administrative Office
Hong Kong, , Hong Kong
Sanofi-Aventis Administrative Office
Budapest, , Hungary
Sanofi-Aventis Administrative Office
Mumbai, , India
Sanofi-Aventis Administrative Office
Dublin, , Ireland
Sanofi-Aventis Administrative Office
Netanya, , Israel
Sanofi-Aventis Administrative Office
Milan, , Italy
Sanofi-Aventis Administrative Office
Kuala Lumpur, , Malaysia
Sanofi-Aventis Administrative Office
México, , Mexico
Sanofi-Aventis Administrative Office
Gouda, , Netherlands
Sanofi-Aventis Administrative Office
Lysaker, , Norway
Sanofi-Aventis Administrative Office
Lima, , Peru
Sanofi-Aventis Administrative Office
Makati City, , Philippines
Sanofi-Aventis Administrative Office
Warsaw, , Poland
Sanofi-Aventis Administrative Office
Porto Salvo, , Portugal
Sanofi-Aventis Administrative Office
Bucharest, , Romania
Sanofi-Aventis Administrative Office
Moscow, , Russia
Sanofi-Aventis Administrative Office
Singapore, , Singapore
Sanofi-Aventis Administrative Office
Midrand, , South Africa
Sanofi-Aventis Administrative Office
Seoul, , South Korea
Sanofi-Aventis Administrative Office
Madrid, , Spain
Sanofi-Aventis Administrative Office
Bromma, , Sweden
Sanofi-Aventis Administrative Office
Geneva, , Switzerland
Sanofi-Aventis Administrative Office
Taipei, , Taiwan
Sanofi-Aventis Administrative Office
Bangkok, , Thailand
Sanofi-Aventis Administrative Office
Mégrine, , Tunisia
Sanofi-Aventis Administrative Office
Istanbul, , Turkey (Türkiye)
Sanofi-Aventis Administrative Office
Guildford, , United Kingdom
Countries
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References
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Topol EJ, Bousser MG, Fox KA, Creager MA, Despres JP, Easton JD, Hamm CW, Montalescot G, Steg PG, Pearson TA, Cohen E, Gaudin C, Job B, Murphy JH, Bhatt DL; CRESCENDO Investigators. Rimonabant for prevention of cardiovascular events (CRESCENDO): a randomised, multicentre, placebo-controlled trial. Lancet. 2010 Aug 14;376(9740):517-23. doi: 10.1016/S0140-6736(10)60935-X.
Bhatia G, Bansal V, Harismendy O, Schork NJ, Topol EJ, Frazer K, Bafna V. A covering method for detecting genetic associations between rare variants and common phenotypes. PLoS Comput Biol. 2010 Oct 14;6(10):e1000954. doi: 10.1371/journal.pcbi.1000954.
Other Identifiers
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2005-002942-20
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
EFC5826
Identifier Type: -
Identifier Source: org_study_id
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