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Comparison of Efficacy and Safety of Rimonabant 5mg/Day or 20mg/Day Versus Placebo in Smoking Cessation — STRATUS-EU  

Smoking Cessation Clinical Trial

Official title:
Comparison of the Efficacy and Safety of 2 Oral Doses of Rimonabant, 5mg/Day or 20mg/Day, Versus Placebo, as an Aid to Smoking Cessation; Multiple Country, Randomized, Double-blind, 3-arm, 10-week Treatment, 40-week Follow-up

Clinical Trial 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 of rimonabant on craving and weight and on the clinical and biological safety and tolerability of rimonabant in a population of cigarette tobacco smokers during a 10-week treatment period and to observe the percentage of abstinent subjects during a 40-week follow-up post treatment.

Clinical Trial Description

n/a

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT00464165
Study type Interventional
Source Sanofi
Contact
Status Completed
Phase Phase 3
Start date November 2002
Completion date October 2003
View Details
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