Status:
COMPLETED
Efficacy and Safety of Rimonabant as an Aid to Maintenance of Smoking Cessation
Lead Sponsor:
Sanofi
Conditions:
Maintenance of Smoking Cessation
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
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...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
November 1 2002
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2005
Estimated Enrollment :
4850 Patients enrolled
Trial Details
Trial ID
NCT00459173
Start Date
November 1 2002
End Date
September 1 2005
Last Update
April 7 2009
Active Locations (3)
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1
Sanofi-Aventis
Bridgewater, New Jersey, United States, 08807
2
Sanofi-Aventis
Cove, New South Wales, Australia
3
Sanofi-Aventis
Laval, Quebec, Canada