Objectives: * Primary: To evaluate the effect of rimonabant 20-mg once daily in comparison with placebo, on the quantitative progression of atherosclerosis as assessed by carotid artery intima-media thickness (CIMT) * Secondary: To evaluate the safety and tolerability of the above rimonabant regimen in the study population of atherosclerosis patients.
This is a Phase III, prospective, multicentre, multinational, randomized, double-blind, placebo-controlled, 2-arm parallel group trial (rimonabant 20-mg od vs placebo). There will be a three-stage screening process including successively a Screening visit, a Screening CIMT and a validation of the Screening CIMT by the Imaging Core Laboratory. Patients complying with all inclusion and exclusion criteria will be randomized in one of the 2 treatment groups less than two weeks after Screening visit. Study drug (rimonabant 20 mg od or matching placebo) will be administered during 30 to 32 months. At inclusion, patients will be counseled to follow a mild hypocaloric diet, to increase their exercise level, and to stop smoking (if smokers). Glucose/lipid parameters will be assessed at Baseline and every 6 months until the Month 30 visit. CIMT will be performed at Baseline and every 6 months until final assessment at Month 30 (primary endpoint).A post-treatment follow-up visit at Month 35 will allow the collection of all adverse events and cardiovascular outcomes occurring after last study drug administration
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
661
Tablet, oral administration
Tablet, oral administration
Sanofi-Aventis Administrative Office
Bridgewater, New Jersey, United States
Sanofi-Aventis Administrative Office
Laval, Canada
Sanofi-Aventis Administrative Office
Paris, France
Sanofi-Aventis Administrative Office
Gouda, Netherlands
Absolute change from baseline in averaged per patient carotid artery intima-media thickness (CIMT)
Time frame: Month 30
First occurrence of any component of stroke/myocardial infarction (MI)/cardiovascular death
Time frame: From randomization to Month 35
First occurrence of any component of stroke/MI/cardiovascular death/hospitalization for revascularization procedure, unstable angina, transient ischemic attack (TIA)
Time frame: From randomization to Month 35
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Sanofi-Aventis Administrative Office
Barcelona, Spain
Sanofi-Aventis Administrative Office
Guildford Surrey, United Kingdom