Efficacy and Safety of Rimonabant as an Aid to Maintenance of Smoking Cessation (STRATUS-WW)
Status and phase
Completed
Phase 3
Conditions
Maintenance of Smoking Cessation
Treatments
Drug: rimonabant (SR141716)
Details and patient eligibility
About
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.
Enrollment
4,850 patients
Sex
All
Ages
18+ years old
Volunteers
No Healthy Volunteers
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
Trial design
Primary purpose
Treatment
Allocation
Randomized
Interventional model
Parallel Assignment
Masking
Double Blind
Trial contacts and locations
3
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Data sourced from clinicaltrials.gov
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