Status:
COMPLETED
Comparison of Efficacy and Safety of Rimonabant 5mg/Day or 20mg/Day Versus Placebo in Smoking Cessation
Lead Sponsor:
Sanofi
Conditions:
Smoking Cessation
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
The primary objective is to assess the efficacy of 2 fixed doses of rimonabant versus placebo on abstinence from tobacco use in cigarette smokers. The secondary objective is to evaluate the effects o...
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 :
October 1 2003
Estimated Enrollment :
789 Patients enrolled
Trial Details
Trial ID
NCT00464165
Start Date
November 1 2002
End Date
October 1 2003
Last Update
December 10 2010
Active Locations (7)
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1
Sanofi-Aventis Administrative Office
Diegem, Belgium
2
Sanofi-Aventis Administrative Office
Hørsholm, Denmark
3
Sanofi-Aventis Administrative Office
Paris, France
4
Sanofi-Aventis Administrative Office
Barcelona, Spain