drugset / Trial / NCT00263042

Comprehensive Rimonabant Evaluation Study of Cardiovascular ENDpoints and Outcomes

NCT00263042 ↗

Phase 3 Terminated 18695 enrolled Sanofi
RandomizedParallel-groupQuadruple-blindTreatment

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.

Timeline

Start
2005-12
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 hazard ratio 0.97, 95% CI 0.84-1.12, p=0.68 PMID 20709233 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject Rimonabant Small molecule 20 mg Oral