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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 Smoking Cessation (STRATUS US)

NCT00358228 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 787

Last updated 2010-12-10

No results posted yet for this study

Summary

The primary study objective was to assess the efficacy of 2 fixed doses of rimonabant versus placebo on abstinence from tobacco use in cigarette smokers.

The secondary study objectives were:

* To evaluate the effects of rimonabant on craving and weight;
* To evaluate the clinical and biological safety and tolerability of rimonabant in a population of cigarette tobacco smokers during a 10-week treatment period
* To evaluate the population pharmacokinetics of rimonabant (ie, standard PK evaluation in the population of smokers);
* To observe the percentage of abstinent patients during a 40-week follow-up post treatment period;
* To evaluate quality of life (QOL) and pharmacoeconomics.

Conditions

  • Smoking Cessation

Interventions

DRUG

Rimonabant

Sponsors & Collaborators

Principal Investigators

  • Lowell C. DALE, MD · Mayo Clinic 200 First Street SW, Rochester, Minnesota 55905, US

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2002-09-30
Primary Completion
2003-08-31
Completion
2003-08-31

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00358228 on ClinicalTrials.gov