An Open Label Study That Compares Varenicline to Transdermal Nicotine Patch for Smoking Cessation
Phase 3
Completed
- Conditions
- Smoking Cessation
- Registration Number
- NCT00143325
- Lead Sponsor
- Pfizer
- Brief Summary
Open-label comparison of standard 12-week regimen of varenicline with standard 10-week regimen of transdermal nicotine patch for smoking cessation.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 730
Inclusion Criteria
- Subjects must have smoked an average of at least 15 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 for the last 4 weeks of varenicline and NRT (Nicotine Replacement Therapy) treatment period
- Secondary Outcome Measures
Name Time Method Continuous abstinence last 4 weeks of treatment through Weeks 24 and 52 7-day point prevalence of abstinence: end of treatment, Weeks 24 and 52 4-week Point Prevalence of abstinence at Week 52 Long-Term Quit Rate at Weeks 24 and 52 Minnesota Nicotine Withdrawal Scale Smoking Effects Inventory
Trial Locations
- Locations (1)
Pfizer Investigational Site
🇬🇧Nottingham, United Kingdom