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)
This study has been completed.
Information provided by:
First received: July 28, 2006
Last updated: December 9, 2010
Last verified: December 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.
|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 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.|
Resource links provided by NLM:
Further study details as provided by Sanofi:
Primary Outcome Measures:
- 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.
Secondary Outcome Measures:
- 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.
|Study Start Date:||September 2002|
|Study Completion Date:||August 2003|
|Primary Completion Date:||August 2003 (Final data collection date for primary outcome measure)|
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00358228
|United States, Pennsylvania|
|Sanofi-Aventis Administrative Office|
|Malvern, Pennsylvania, United States, 19355|
Sponsors and Collaborators
|Principal Investigator:||Lowell C. DALE, MD||Mayo Clinic 200 First Street SW, Rochester, Minnesota 55905, US|