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A 12-Week, Randomized, Double-Blind, Placebo-Controlled, Multicenter Trial With 40-Week Follow-Up Evaluating The Safety And Efficacy Of Varenicline Tartrate For Smoking Cessation In Patients With Mild-To-Moderate Chronic Obstructive Pulmonary Disease
This study is to be conducted in subjects with mild-to-moderate COPD who are cigarette smokers with the intent of demonstrating differences in smoking cessation between varenicline and placebo.
Details
| Lead sponsor | Pfizer |
|---|---|
| Phase | Phase 3 |
| Status | COMPLETED |
| Enrolment | 504 |
| Start date | 2006-05 |
| Completion | 2009-04 |
Conditions
- Smoking Cessation
Interventions
- placebo
- Varenicline Tartarate
Primary outcomes
- Number of Subjects With Four Week Continuous Quit Rate (CQR) — Week 9 through Week 12
Number of subjects who reported no smoking and no use of other nicotine-containing products since the last study visit (on the Nicotine Use Inventory \[NUI\]) and with end-expiratory exhaled carbon monoxide (CO) measurement less than or equal to 10 parts per million (ppm) for weeks 9 through 12 (inclusive).
Countries
United States, France, Italy, Spain