Comparison of Efficacy and Safety of Rimonabant 5mg/Day or 20mg/Day Versus Placebo in Smoking Cessation
NCT ID: NCT00464165
Last Updated: 2010-12-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
789 participants
INTERVENTIONAL
2002-11-30
2003-10-31
Brief Summary
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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.
Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Interventions
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rimonabant
Eligibility Criteria
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Inclusion Criteria
* Motivated to quit with a score greater than or equal to 6 on the ten-point Motivation Scale
Exclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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Sanofi
INDUSTRY
Responsible Party
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sanofi-aventis
Principal Investigators
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Clinical Sciences & Operations
Role: STUDY_DIRECTOR
Sanofi
Locations
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Sanofi-Aventis Administrative Office
Diegem, , Belgium
Sanofi-Aventis Administrative Office
Hørsholm, , Denmark
Sanofi-Aventis Administrative Office
Paris, , France
Sanofi-Aventis Administrative Office
Barcelona, , Spain
Sanofi-Aventis Administrative Office
Bromma, , Sweden
Sanofi-Aventis Administrative Office
Geneva, , Switzerland
Sanofi-Aventis Administrative Office
Guildford, Surrey, United Kingdom
Countries
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Other Identifiers
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SR141716
Identifier Type: -
Identifier Source: secondary_id
EFC4474
Identifier Type: -
Identifier Source: org_study_id