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

This study has been completed.
Sponsor:
Information provided by:
Sanofi
ClinicalTrials.gov Identifier:
NCT00464256
First received: April 20, 2007
Last updated: December 9, 2010
Last verified: December 2010

April 20, 2007
December 9, 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
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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.
 
Completed
533
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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00464256
EFC5794, SR141716
Not Provided
Trial Transparency Team, sanofi-aventis
Sanofi
Not Provided
Study Director: Clinical Sciences & Operations Sanofi
Sanofi
December 2010

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