drugset / Trial / NCT00464165

Comparison of Efficacy and Safety of Rimonabant 5mg/Day or 20mg/Day Versus Placebo in Smoking Cessation

NCT00464165

Phase 3 Completed 789 enrolled Sanofi
RandomizedParallel-groupDouble-blindTreatment

Summary

The primary objective is to assess the efficacy of 2 fixed doses of rimonabant versus placebo on abstinence from tobacco use in cigarette smokers. The secondary objective is to evaluate the effects of rimonabant on craving and weight and on the clinical and biological safety and tolerability of rimonabant in a population of cigarette tobacco smokers during a 10-week treatment period and to observe the percentage of abstinent subjects during a 40-week follow-up post treatment.

Timeline

Start
2002-11
Primary completion
2003-10
Completion
2003-10

Drugs

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

Indications

No indication recorded.