drugset / Trial / NCT00405808

Rimonabant in Abdominally Obese Patients With Impaired Fasting Blood Glucose

NCT00405808

Phase 3 Terminated 2666 enrolled Sanofi
RandomizedParallel-groupDouble-blindTreatment

Summary

Primary objective: To determine the effect of Rimonabant 20mg on the co-primary endpoint including Fasting Plasma Glucose (FPG), HDL-Cholesterol (HDL-C) and triglyceride (TG) levels over a period of 12 months when prescribed with a mild hypocaloric diet in abdominally obese patients with impaired fasting blood glucose and with or without associated comorbidities. Main Secondary objectives: To determine the effect of 12 months Rimonabant treatment versus placebo on changes in waist circumference (WC), body weight, glycemic parameters and lipid parameters. To assess the safety of 12 months Rimonabant treatment versus placebo in these patients.

Timeline

Start
2006-12
Primary completion
2009-02
Completion
2009-02

Drugs

EvaluationDrugModalityDoseRoute
Subject Rimonabant Small molecule 20 mg

Indications