drugset / Trial / NCT00412698

European Trial About Effect of RimoNabant on Abdominal Obese Patients With dysLipidemia

NCT00412698

Phase 3 Terminated 645 enrolled Sanofi
RandomizedParallel-groupDouble-blindTreatment

Summary

Primary : To determine the effect of Rimonabant 20 mg on changes in, HDL-Cholesterol (HDL-C), triglyceride levels over a period of 12 months when prescribed with a mild hypocaloric diet in abdominally obese patients with dyslipidemia with or without other associated comorbidities. Main Secondary : To determine the effect of 12 months Rimonabant treatment versus placebo on changes in waist circumference (WC), body weight, glycemic and lipid parameters. To assess the safety of 12 months Rimonabant treatment versus placebo in these patients. In selected sites, a sub study will be conducted to determine the effect of 12 months of Rimonabant on additional lipoprotein and inflammatory parameters.

Timeline

Start
2006-12
Primary completion
2009-01
Completion
2009-01

Drugs

EvaluationDrugModalityDoseRoute
Subject Rimonabant Small molecule 20 mg Oral