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Comparison of Efficacy and Safety of Rimonabant 20mg/Day Versus Placebo in Smoking Cessation (STRATUS-META)

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ClinicalTrials.gov Identifier: NCT00464256
Recruitment Status : Completed
First Posted : April 23, 2007
Last Update Posted : December 10, 2010
Information provided by:

April 20, 2007
April 23, 2007
December 10, 2010
April 2004
November 2004   (Final data collection date for primary outcome measure)
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
Same as current
Complete list of historical versions of study NCT00464256 on ClinicalTrials.gov Archive Site
  • 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
  • Safety data
Same as current
Not Provided
Not Provided
Comparison of Efficacy and Safety of Rimonabant 20mg/Day Versus Placebo in Smoking Cessation
Comparison of the Efficacy and Safety of a 20 mg/Day Oral Dose of Rimonabant Versus Placebo as an Aid to Smoking Cessation - a US, Randomized, Double-blind, 2 Arm, Placebo-controlled, Parallel-group, Fixed Dose, 12-week Study

The primary objective is to assess the efficacy a 20mg/day fixed dose of rimonabant versus placebo on abstinence from tobacco use in cigarette smoker.

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.

Not Provided
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Smoking Cessation
Drug: rimonabant
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
November 2004
November 2004   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
United States
Not Provided
Not Provided
Not Provided
Trial Transparency Team, sanofi-aventis
Not Provided
Study Director: Clinical Sciences & Operations Sanofi
December 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP