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

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.

Timeline

Start

2005-08

Primary completion

2009-04

Completion

2009-04

Outcome

Missed primary endpoint

Stopped: “Company decision taken in light of demands by certain national health authorities”

paper There was no difference in atherosclerosis progression between patients receiving rimonabant for 30 months and those receiving placebo for the primary efficacy measure PMID 21610270 ↗

paper 0.010 ± 0.095 mm in the rimonabant group and 0.012 ± 0.091 mm in the placebo group (p=0.67). PMID 21610270 ↗

Publications

• Results O'Leary DH, Reuwer AQ, Nissen SE, Despres JP, Deanfield JE, Brown MW, Zhou R, Zabbatino SM, Job B, Kastelein JJ, Visseren FL; AUDITOR investigators. Effect of rimonabant on carotid intima-media thickness (CIMT) progression in patients with abdominal obesity and metabolic syndrome: the AUDITOR Trial. Heart. 2011 Jul;97(14):1143-50. doi: 10.1136/hrt.2011.223446. Epub 2011 May 24.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Rimonabant	Small molecule	20 mg	Oral

Indications