Comprehensive Rimonabant Evaluation Study of Cardiovascular ENDpoints and Outcomes "CRESCENDO"


Phase 3 Results N/A

Eligibility 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