Cardiovascular Disease
Conditions
Keywords
Myocardial infarction, cerebrovascular accident, obesity
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) risk factors. The secondary objective is to show whether rimonabant reduces the risk of MI, stroke, CV death, or CV hospitalization in these patients.
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 for 33 months.
Interventions
DRUGRimonabant
Tablet, oral administration
Tablet, oral administration
Sponsors
Sanofi
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
55 Years to No maximum
Healthy volunteers
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| First occurrence of any of myocardial infarction, stroke or cardiovascular (CV) death | From randomization up to common study end date (33-50 months) |
Secondary
| Measure | Time frame |
|---|---|
| First occurrence of any of myocardial infarction, stroke, CV death, and CV hospitalization | From randomization up to common study end date (33-50 months) |
| All-cause mortality | From randomization up to common study end date (33-50 months) |
Countries
Argentina, Australia, Austria, Belgium, Brazil, Canada, Chile, China, Colombia, Czechia, Denmark, Finland, France, Germany, Greece, Hong Kong, Hungary, India, Ireland, Israel, Italy, Malaysia, Mexico, Netherlands, Norway, Peru, Philippines, Poland, Portugal, Romania, Russia, Singapore, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, Tunisia, Turkey (Türkiye), United Kingdom, United States
Outcome results
None listed