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NCT00358228 · ClinicalTrials.gov registry record · Phase 3
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)
A Phase 3 study, sponsored by Sanofi.
- Completed
- Registry status
- Phase 3
- Development phase
- 787
- Enrollment target
NCT00358228: Completed Phase 3 study, sponsored by Sanofi.
NCT00358228 is a Phase 3 study that has completed, run by Sanofi. The registered enrollment target is 787 participants, roughly in line with the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00358228, a Phase 3 study, has completed, sponsored by Sanofi.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 787 participants
- Enrollment target
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.
Interventions
- DRUG Rimonabant
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 787 participants |
| Start Date | 2002-09 |
| Est. Completion | 2003-08 |
| Phase | Phase 3 |
What the finished NCT00358228 record still lists
NCT00358228 is an interventional study that assigns participants to a tested intervention. The registered 787 participants enrollment target is mid-sized for trials with a published cap, roughly in line with the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target.
The record links to 0 conditions, and to 1 intervention - of which Rimonabant is the first listed.
NCT00358228 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00358228 about?
NCT00358228 is a clinical study titled "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)". 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 sa...
What is the current status of trial NCT00358228?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 787 participants. The study started on 2002-09. Estimated completion is 2003-08.
What interventions are being tested in trial NCT00358228?
The interventions under investigation include: Rimonabant (DRUG).
Who is sponsoring clinical trial NCT00358228?
This trial is sponsored by Sanofi, which has 713 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00358228's enrollment target sits among peer trials
787 431st of 2000 higher than 1,570 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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