NCT00228176

Atherosclerosis Underlying Development Assessed by Intima-Media Thickness in Patients on Rimonabant

Randomized, Multicenter, Double-blind, Placebo-controlled, Two-arm Parallel Group Trial of Rimonabant 20-mg od, for Inhibition of Atherosclerosis Progression Assessed by Carotid Artery Intima-media Thickness (CIMT), in Overweight Patients With Additional Risk Factors

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 661 (actual)
• Sponsor: Sanofi · Industry
• Sex: All
• Age: 55 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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

Conditions

• Carotid Artery Plaque
• Arteriosclerosis
• Obesity
• Metabolic Syndrome X

Interventions

Type	Name	Description
DRUG	Rimonabant	Tablet, oral administration
DRUG	Placebo (for Rimonabant)	Tablet, oral administration

Timeline

• Start date: 2005-08-01
• Primary completion: 2009-04-01
• Completion: 2009-04-01
• First posted: 2005-09-28
• Last updated: 2016-05-20

Locations

6 sites across 6 countries: United States, Canada, France, Netherlands, Spain, United Kingdom