A Seven-Week Dose-Ranging Study of CP-526,555 Compared With Placebo and Zyban for Smoking Cessation
Phase 2
Completed
- Conditions
- Smoking Cessation
- Registration Number
- NCT00150241
- Lead Sponsor
- Pfizer
- Brief Summary
The purpose of the study is to measure the safety and efficacy of three doses of varenicline for smoking cessation.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 625
Inclusion Criteria
- Subjects must have smoked on average of at least ten cigarettes per day during the past year
- Subjects must have no period of abstinence greater than three months in the past year
Exclusion Criteria
- Subjects with any history of cardiovascular disease
- Myocardial infarction
- Significant arrhythmias
- Poorly controlled hypertension
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method The primary efficacy outcome is smoking abstinence for any continuous 4-week period (4-week CQR) during the study treatment phase.
- Secondary Outcome Measures
Name Time Method Smoking Effects Inventory Fixed window 4-week CQR, Weeks 3-6, 4-7 Continuous abstinence from Target Quit Date to Weeks 12, 24, and 52 7-day Point Prevalence of abstinence Week 52 Number of cigarettes smoked per day Minnesota Nicotine Withdrawal Scale Brief Questionnaire of Smoking Urge
Trial Locations
- Locations (1)
Pfizer Investigational Site
🇺🇸Morgantown, West Virginia, United States