Status:
TERMINATED
Comprehensive Rimonabant Evaluation Study of Cardiovascular ENDpoints and Outcomes
Lead Sponsor:
Sanofi
Conditions:
Cardiovascular Disease
Eligibility:
All Genders
55+ years
Phase:
PHASE3
Brief 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) ris...
Detailed Description
The estimated study duration per patient is 36 to 53 months. All patients will be followed from randomization until a common study end date, which will occur when the last patient has been followed fo...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
December 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2009
Estimated Enrollment :
18695 Patients enrolled
Trial Details
Trial ID
NCT00263042
Start Date
December 1 2005
End Date
April 1 2009
Last Update
May 20 2016
Active Locations (43)
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1
Sanofi-Aventis Administrative Office
Bridgewater, New Jersey, United States, 08807
2
Sanofi-Aventis Administrative Office
Buenos Aires, Argentina
3
sanofi-aventis Australia & New Zealand administrative office
Macquarie Park, New South Wales, Australia
4
Sanofi-Aventis Administrative Office
Vienna, Austria