NCT00459173CompletedPhase 3
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 Maintenance of Smoking Cessation (1-Year Treatment, 1-Year Follow-up)
Conditions
Drugs
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- Sanofi
- Enrollment
- 4,850
- Locations
- 3
- Primary Endpoint
- Time to smoking relapse from the point of re-randomization (Week 10) through Week 32
Study Overview
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 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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 Criteria
- •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
Outcomes
Primary Outcomes
Time to smoking relapse from the point of re-randomization (Week 10) through Week 32
Smoking relapse defined as: any 7 or more consecutive days of smoking (even a puff) or any 2 consecutive days of smoking 5 or more cigarettes per day
Secondary Outcomes
- Safety data
- Efficacy: Time to smoking relapse from Week 10 to Week 52, craving, body weight change in abstainers, lipid parameters
Investigators
Study Sites (3)
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