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Sponsored by: |
Sanofi-Aventis |
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Information provided by: | Sanofi-Aventis |
ClinicalTrials.gov Identifier: | NCT00387946 |
The primary study objective is to demonstrate the efficacy of dianicline as an aid to smoking cessation in cigarette smokers. The main secondary objectives are to assess the: craving for cigarettes, nicotine withdrawal symptoms, and safety of dianicline.
Condition | Intervention | Phase |
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Smoking Cessation Tobacco Use Cessation |
Drug: SSR591813L (dianicline) |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study |
Official Title: | An International, Seven-Week, Double-Blind, Placebo-Controlled, Two Parallel Group Study to Assess the Efficacy of Dianicline 40 mg Bid as an Aid to Smoking Cessation in Cigarette Smokers |
Estimated Enrollment: | 600 |
Study Start Date: | September 2006 |
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Patients who currently present with (based on Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition [DSM-IV]):
Study ID Numbers: | EFC5514, SSR591813 |
Study First Received: | October 12, 2006 |
Last Updated: | October 19, 2007 |
ClinicalTrials.gov Identifier: | NCT00387946 |
Health Authority: | United States: Food and Drug Administration |
smoking cessation tobacco |
Smoking |
Habits |