A Phase 3 interventional study of Rimonabant and Placebo (for Rimonabant) in Carotid Artery Plaque, Arteriosclerosis and Obesity, sponsored by Sanofi. Terminated at 6 sites in 6 countries. Open to participants aged 55 Years and older. Per ClinicalTrials.gov, last updated 2016-05-20.
Sponsored by Sanofi · Phase 3, Interventional, and Treatment
Objectives:
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
339 studies on the registry are indexed under Carotid Stenosis; 81 are open to participants now.
This study's enrollment of 661 is above the median of 106 across 182 interventional studies indexed under Carotid Stenosis.
Browse Carotid Stenosis studies →Sanofi is the lead sponsor of 1,508 studies on the registry; 90 are open to participants now.
Of its 198 completed or terminated interventional studies of FDA-regulated products, 118 (60%) have results posted.
Counted across the registry records on this site, refreshed daily.
Metabolic syndrome diagnosed on the basis of at least two of the following additional risk factors:
Exclusion Criteria:
Rimonabant 20 mg once daily
Drug: Rimonabant
Placebo (for Rimonabant) once daily.
Drug: Placebo (for Rimonabant)
Tablet, oral administration
Also known as: SR141716, Acomplia
Tablet, oral administration
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
This study is terminated, as verified in Apr 2016. You cannot join it, but the record below documents what was studied.
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Sanofi