Efficacy and Safety of Rimonabant as an Aid to Smoking Cessation With or Without Nicotine Patch
NCT00458718 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 755
Last updated 2009-04-20
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 from smoking in cigarette smokers motivated to quit.
Secondary objectives are to evaluate the clinical and biological safety of rimonabant associated with nicotine replacement therapy during a 9-week treatment period and to evaluate the effect of the combination on weight and craving.
Conditions
- Smoking Cessation
Interventions
- DRUG
-
rimonabant (SR141716)
Sponsors & Collaborators
- lead INDUSTRY
Principal Investigators
-
ICD CSD · Sanofi
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- DOUBLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2004-09-30
- Primary Completion
- 2005-07-31
- Completion
- 2005-07-31
Countries
- United States
Study Locations
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