A 52-Week Multicenter Study Evaluating the Safety and Efficacy of Varenicline for the Maintenance of Smoking Cessation
Phase 3
Completed
- Conditions
- Smoking Cessation
- Registration Number
- NCT00143286
- Lead Sponsor
- Pfizer
- Brief Summary
The primary purpose of this study is a comparison of abstinence maintenance in subjects randomized to double-blind varenicline or placebo from Weeks 13 -24 in subjects who responded to an intial 12-week open label course of varenicline, with post-treatment follow-up of smoking status to Week 52.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 2000
Inclusion Criteria
- Subjects must have smoked an average of at least 10 cigarettes per day during the past year and over the month prior to the screening visit, with no period of abstinence greater than 3 months in the past year.
Exclusion Criteria
- Subjects with clinically significant cardiovascular disease in the past 6 months.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Continuous abstinence Weeks 13 -24.
- Secondary Outcome Measures
Name Time Method Continuous abstinence Weeks 13-52 Long term quit rate at Week 52 7-day Point Prevalence of abstinence at Weeks 24, 52 4-week Point Prevalence of abstinence at Week 52 Time to first cigarette post randomization
Trial Locations
- Locations (1)
Pfizer Investigational Site
🇬🇧London, United Kingdom