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)
Public ClinicalTrials.gov record NCT00358228. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
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, EFC4964) - A Randomized, Double-blind, 3-arm, Placebo-controlled, Parallel-group, Fixed-dose, 52-week, Multi-center Study.
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT00358228
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 787 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Sep 2002 (Type not available)
- Primary completion
- Aug 2003 (Actual)
- Completion
- Aug 2003 (Actual)
- Last update posted
- Dec 10, 2010
2002 – 2003
United States locations
- U.S. sites
- 1
- U.S. states
- 1
- U.S. cities
- 1
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Sanofi-Aventis Administrative Office | Malvern | Pennsylvania | 19355 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT00358228, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Dec 10, 2010 · Synced Oct 19, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT00358228 live on ClinicalTrials.gov.