Comparison of Efficacy and Safety of Rimonabant 20mg/Day Versus Placebo in Smoking Cessation (STRATUS-META)
The primary objective is to assess the efficacy a 20mg/day fixed dose of rimonabant versus placebo on abstinence from tobacco use in cigarette smoker.
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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
|Official Title:||Comparison of the Efficacy and Safety of a 20 mg/Day Oral Dose of Rimonabant Versus Placebo as an Aid to Smoking Cessation - a US, Randomized, Double-blind, 2 Arm, Placebo-controlled, Parallel-group, Fixed Dose, 12-week Study|
- Prolonged abstinence from smoking during the last 4 weeks of treatment reported by the subject and confirmed by exhaled carbon monoxide (CO) and cotinine measurements
- Efficacy: mean change of the total score of Questionnaire on Smoking Urges (QSU) brief scale, categorical change in body weight in subjects with Body Mass Index lower than 30 kg/m² at baseline who achieve prolonged abstinence
- Safety data
|Study Start Date:||April 2004|
|Study Completion Date:||November 2004|
|Primary Completion Date:||November 2004 (Final data collection date for primary outcome measure)|