Comprehensive Rimonabant Evaluation Study of Cardiovascular ENDpoints and Outcomes

Stopped early · Phase 3 · Has a placebo group

Conditions studied: Cardiovascular Disease

In brief

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.

Key facts

Study ID

NCT00263042

Run by

Sanofi

People needed

18695

Starts

2005-12-01

Expected to finish

2009-04-01

Last updated by the study team

2016-05-20

Who can join

Age: 55 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• 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

Full record on ClinicalTrials.gov

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