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A 12-Week, Double-Blind, Randomized, Placebo-Controlled, Multicenter Study With Follow-Up Evaluating The Safety And Efficacy Of Varenicline Tartrate (CP-526,555-18) 1 Mg Bid For Smoking Cessation (Protocol A3051080)
The primary objective of this protocol is to evaluate 12 weeks of treatment of varenicline compared to placebo for smoking cessation. Abstinence from cigarette smoking and other tobacco products (e.g., pipe, cigars, chew, snuff.) use during non-treatment follow-up period will also be evaluated.
Details
| Lead sponsor | Pfizer |
|---|---|
| Phase | Phase 4 |
| Status | COMPLETED |
| Enrolment | 593 |
| Start date | 2008-04 |
| Completion | 2009-08 |
Conditions
- Smoking Cessation
Interventions
- varenicline tartrate (CP-526, 555-18)
- Placebo
Primary outcomes
- Number of Participants With 4-week Continuous Abstinence — Weeks 9 through 12
The number of participants who, at each visit from Week 9 through 12 (inclusive), reported no smoking and no use of other nicotine-containing products since the last study visit (on the Nicotine Use Inventory) and who did not have carbon monoxide (CO) \> 10 parts per milion (ppm) at any of these visits
Countries
Brazil, Colombia, Costa Rica, Egypt, Jordan, Lebanon, Mexico, Saudi Arabia, South Africa, United Arab Emirates, Venezuela