Comprehensive Rimonabant Evaluation Study of Cardiovascular ENDpoints and Outcomes

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”

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.

Intervention(s) in this Clinical Trial

• Drug: rimonabant (SR141716)
  • 20 mg once daily
• Drug: placebo
  • once daily

Arms, Groups and Cohorts in this Clinical Trial

• Active Comparator: 1
• Placebo Comparator: 2

Primary Measures

• First occurrence of myocardial infarction, stroke, and cardiovascular (CV) death
  • Time Frame: study period
    Safety Issue?: No

Secondary Measures

• First occurrence of myocardial infarction, stroke, CV death, and CV hospitalization
  • Time Frame: study period
    Safety Issue?: No
• All-cause mortality
  • Time Frame: study period
    Safety Issue?: 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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 55 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Investigator: Sanofi-Aventis Industry

Overall Clinical Trial Officials and Contacts

Eric Topol, MD Study Chair Scripps Clinic  

Information obtained from ClinicalTrials.gov on February 12, 2012

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00263042

Study ID Number: EFC5826

ClinicalTrials.gov Identifier: NCT00263042

Health Authority: United States: Food and Drug Administration