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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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19 February 2015 |
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Main ID: |
NCT00464165 |
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Date of registration:
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20/04/2007 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Comparison of Efficacy and Safety of Rimonabant 5mg/Day or 20mg/Day Versus Placebo in Smoking Cessation
STRATUS-EU |
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Scientific title:
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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 |
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Date of first enrolment:
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November 2002 |
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Target sample size:
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789 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00464165 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
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Phase:
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Phase 3
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Countries of recruitment
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Belgium
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Denmark
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France
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Spain
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Sweden
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Switzerland
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United Kingdom
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Contacts
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Name:
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Clinical Sciences & Operations |
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Address:
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Telephone:
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Email:
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Affiliation:
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Sanofi |
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Key inclusion & exclusion criteria
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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
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Smoking Cessation
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Intervention(s)
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Drug: rimonabant
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Primary Outcome(s)
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Prolonged abstinence from smoking during the last 4 weeks of treatment reported by the subject and confirmed by exhaled carbon monoxide (CO) and cotinine measurements
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Secondary Outcome(s)
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Efficacy: mean change of the total score of Questionnaire on Smoking Urges (QSU) brief scale, categorical change in body weight in subjects with Body Mass Index lower than 30 kg/m² at baseline who achieve prolonged abstinence
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Safety data
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Secondary ID(s)
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EFC4474
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SR141716
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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