Efficacy and Safety of Rimonabant as an Aid to Maintenance of Smoking Cessation
Completed · Phase 3
Conditions studied: Maintenance of Smoking Cessation
In brief
The primary study objective is to evaluate the efficacy of 2 dose levels of rimonabant (5 mg and 20 mg) for the maintenance of abstinence from smoking. Secondary objectives are to evaluate the effect of rimonabant on craving and weight, the clinical and biological safety of 2 doses of rimonabant rimonabant during a 12-month treatment period and to evaluate the pharmacokinetics of the drug.
Key facts
- Study ID
- NCT00459173
- Run by
- Sanofi
- People needed
- 4850
- Starts
- 2002-11-01
- Expected to finish
- 2005-09-01
- Last updated by the study team
- 2009-04-07
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Smokers smoking at least 10 cigarettes/day as a mean within the 2 months preceding the screening visit
- Motivated to quit with a score greater than or equal to 6 on the ten-point Motivation Scale
You may not qualify if…
- non tobacco cigarettes consumption
- chronic use of marijuana
- pregnancy, breastfeeding
- any clinically significant disease that might interfere with the efficacy or safety evaluation of the study drug
- Concomitant use of drugs as an aid to smoking cessation or that might induce weight change
Where it is running
- Sanofi-Aventis — Bridgewater, New Jersey, United States
- Sanofi-Aventis — Cove, New South Wales, Australia
- Sanofi-Aventis — Laval, Quebec, Canada
Full record on ClinicalTrials.gov
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