Status:
COMPLETED
Efficacy and Safety of Rimonabant as an Aid to Smoking Cessation With or Without Nicotine Patch
Lead Sponsor:
Sanofi
Conditions:
Smoking Cessation
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
The primary objective is to compare the efficacy of rimonabant 20 mg OD fixed dose plus nicotine patch 21 mg OD with the combination rimonabant 20 mg OD fixed dose plus placebo patch on abstinence fro...
Eligibility Criteria
Inclusion
- Smokers smoking at least 15 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 :
September 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2005
Estimated Enrollment :
755 Patients enrolled
Trial Details
Trial ID
NCT00458718
Start Date
September 1 2004
End Date
July 1 2005
Last Update
April 20 2009
Active Locations (1)
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1
Sanofi-Aventis
Bridgewater, New Jersey, United States, 08807