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Efficacy and Safety of Rimonabant as an Aid to Maintenance of Smoking Cessation (STRATUS-WW)

This study has been completed.
Sponsor:
Information provided by:
Sanofi
ClinicalTrials.gov Identifier:
NCT00459173
First received: April 10, 2007
Last updated: April 6, 2009
Last verified: April 2009
History of Changes

April 10, 2007
April 6, 2009
November 2002
September 2005   (final data collection date for primary outcome measure)
  • Time to smoking relapse from the point of re-randomization (Week 10) through Week 32
  • 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
Same as current
Complete list of historical versions of study NCT00459173 on ClinicalTrials.gov Archive Site
  • Efficacy: Time to smoking relapse from Week 10 to Week 52, craving, body weight change in abstainers, lipid parameters
  • Safety data
Same as current
Not Provided
Not Provided
 
Efficacy and Safety of Rimonabant as an Aid to Maintenance of Smoking Cessation
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.
Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Maintenance of Smoking Cessation
Drug: rimonabant (SR141716)
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
4850
September 2005
September 2005   (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,   Australia,   Canada
 
NCT00459173
EFC4796
Not Provided
ICD Study Director, sanofi-aventis
Sanofi
Not Provided
Study Director: ICD CSD Sanofi
Sanofi
April 2009

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