Comparison of the Efficacy and Safety of 2 Oral Doses of Rimonabant, 5 mg/Day or 20 mg/Day, Versus Placebo, as an Aid to Smoking Cessation (STRATUS US)

Summary

The primary study objective was to assess the efficacy of 2 fixed doses of rimonabant versus placebo on abstinence from tobacco use in cigarette smokers. The secondary study objectives were: * To evaluate the effects of rimonabant on craving and weight; * To evaluate the clinical and biological safety and tolerability of rimonabant in a population of cigarette tobacco smokers during a 10-week treatment period * To evaluate the population pharmacokinetics of rimonabant (ie, standard PK evaluation in the population of smokers); * To observe the percentage of abstinent patients during a 40-week follow-up post treatment period; * To evaluate quality of life (QOL) and pharmacoeconomics.

Timeline

Start

2002-09

Primary completion

2003-08

Completion

2003-08

Drugs

Indications

No indication recorded.