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)
|ClinicalTrials.gov Identifier: NCT00358228|
Recruitment Status : Completed
First Posted : July 31, 2006
Last Update Posted : December 10, 2010
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.
|Condition or disease||Intervention/treatment||Phase|
|Smoking Cessation||Drug: Rimonabant||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||787 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||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, EFC4964) - A Randomized, Double-blind, 3-arm, Placebo-controlled, Parallel-group, Fixed-dose, 52-week, Multi-center Study.|
|Study Start Date :||September 2002|
|Actual Primary Completion Date :||August 2003|
|Actual Study Completion Date :||August 2003|
- Prolonged abstinence from tobacco smoking during the last 4 weeks of treatment (Day 43 to Day 70) as reported by direct inquiry of the patient by the Investigator, and confirmed by exhaled carbon monoxide (CO) levels, and plasma cotinine measurements.
- Analysis of mean change from baseline to last evaluation of the total score of QSU.
- Brief scale evaluating craving for tobacco cigarettes and relative change in body weight from baseline to last evaluation in patients with BMI lower than 30 kg/m2 at baseline achieving prolonged abstinence.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00358228
|United States, Pennsylvania|
|Sanofi-Aventis Administrative Office|
|Malvern, Pennsylvania, United States, 19355|
|Principal Investigator:||Lowell C. DALE, MD||Mayo Clinic 200 First Street SW, Rochester, Minnesota 55905, US|