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Rimonabant for Smoking Cessation (STRATUS-EU)
NCT00464165Phase 3
Key facts
- Status
- Completed
- Start
- Nov 2002
- Primary completion
- Oct 2003
- Countries
- 7
- Sponsor
- Sanofi
- Modality
- Small Molecules
- Drugs
- rimonabant
- Conditions
- Tobacco Use Disorder (TUD)
01
Overview
Phase 3, randomised, double-blind trial of rimonabant in Tobacco Use Disorder (TUD) (3 arms), sponsored by Sanofi. Primary endpoint: Prolonged abstinence from smoking at 10 weeks. Started Nov 2002; status: completed.
02
Design
3 arms- Study design
- RandomizedDouble-blind
Rimonabant 5mg
Rimonabant 5mg/day
Rimonabant 20mg
Rimonabant 20mg/day
Placebo
Placebo
03
Who it enrols
Smokers smoking >= 10 cigs/day, motivated to quit, no chronic marijuana use, no clinically significant disease.
04
Endpoints
Primary
Prolonged abstinence from smoking
Secondary
Questionnaire on Smoking Urges brief scale total score
Change in body weight
Clinical and biological safety and tolerability
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