Comprehensive Rimonabant Evaluation Study of Cardiovascular ENDpoints and Outcomes

• Status: Terminated
• Trial end date: 2009-04-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sanofi
• Treatments: Rimonabant

Criteria

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