- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00459173
Efficacy and Safety of Rimonabant as an Aid to Maintenance of Smoking Cessation (STRATUS-WW)
Comparison of the Efficacy and Safety of 2 Oral Doses of Rimonabant, 5 mg/Day or 20 mg/Day, Versus Placebo, as an Aid to Maintenance of Smoking Cessation (1-Year Treatment, 1-Year Follow-up)
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Phase 3
Contacts and Locations
Study Locations
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New South Wales
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Cove, New South Wales, Australia
- Sanofi-Aventis
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-
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Quebec
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Laval, Quebec, Canada
- Sanofi-Aventis
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New Jersey
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Bridgewater, New Jersey, United States, 08807
- Sanofi-Aventis
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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Time to smoking relapse from the point of re-randomization (Week 10) through Week 32
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Smoking relapse defined as: any 7 or more consecutive days of smoking (even a puff) or any 2 consecutive days of smoking 5 or more cigarettes per day
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Secondary Outcome Measures
Outcome Measure |
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Safety data
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Efficacy: Time to smoking relapse from Week 10 to Week 52, craving, body weight change in abstainers, lipid parameters
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- EFC4796
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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Memorial University of NewfoundlandCompletedSmoking Cessation | Quality of Life | Smoking, TobaccoCanada
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-
University of VermontMayo Clinic; Alaska Native Tribal Health ConsortiumTerminatedSmoking | Smoking CessationUnited States
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