drugset / Trial / NCT00678483

Long-Term Effect of 10 mg Versus 20 mg Rimonabant in Overweight or Obese Patients

NCT00678483

Phase 3 Terminated 331 enrolled Sanofi
RandomizedParallel-groupQuadruple-blindTreatment

Summary

The primary objective of this study is to assess, over a period of 12 months, the effect on weight loss and weight maintenance of rimonabant 10 mg in comparison with rimonabant 20 mg in overweight/obese patients after an initial treatment period of 6 months with rimonabant 20 mg. Secondary objectives are to assess the effect of rimonabant over a period of 12 months on waist circumference, high-density lipoprotein (HDL)-Cholesterol and triglycerides (TG), fasting plasma glucose (FPG), fasting insulin and to evaluate the long-term safety and tolerability of rimonabant 10 mg and 20 mg over a period of 12 months after randomization in overweight/obese patients.

Timeline

Start
2008-04
Primary completion
2008-11
Completion
2009-02

Drugs

EvaluationDrugModalityDoseRoute
Subject Rimonabant Small molecule 10 mg
Subject Rimonabant Small molecule 20 mg

Indications