drugset / Trial / NCT00386061

Rimonabant in Obesity Over a 2-Year Duration (RIO-Europe)

NCT00386061 ↗

Phase 3 Completed 1507 enrolled Sanofi
RandomizedParallel-groupDouble-blindTreatment

Summary

The primary objective was to assess the effect of SR141716 on weight loss and weight maintenance over a period of one year when prescribed with a hypocaloric diet in obese patients with or without comorbidities. The main secondary objectives were to assess the effect of SR141716 on lipid parameters (HDL-C, TG), glucose tolerance status, the rate of patients with metabolic syndrome, waist circumference, glycemic parameters.

Timeline

Start
2001-10
Primary completion
2004-06
Completion
2004-06

Outcome

Met primary endpoint

paper Weight loss at 1 year was significantly greater in patients treated with rimonabant 5 mg (mean -3.4 kg [SD 5.7]; p=0.002 vs placebo) and 20 mg (-6.6 kg [7.2]; p<0.001 vs placebo) compared with placebo (-1.8 kg [6.4]). PMID 15836887 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject Rimonabant Small molecule 5 mg —
Subject Rimonabant Small molecule 20 mg —

Indications