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 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 Smoking Effects Inventory Brief Questionnaire of Smoking Urge
Related Research Topics
Explore scientific publications, clinical data analysis, treatment approaches, and expert-compiled information related to the mechanisms and outcomes of this trial. Click any topic for comprehensive research insights.
How does varenicline's nicotinic acetylcholine receptor modulation compare to bupropion in smoking cessation trials?
What biomarkers predict response to varenicline versus Zyban in NCT00150241 Phase 2 smoking cessation study?
What are the adverse event profiles of 0.3 mg QD, 1 mg QD, and 1 mg BID varenicline regimens in Pfizer's trial?
How does varenicline's efficacy in 7-week abstinence rates compare to standard-of-care pharmacotherapies for smoking?
What molecular mechanisms underlie varenicline's partial agonism at α4β2 nicotinic receptors for nicotine dependence?
Trial Locations
- Locations (1)
Pfizer Investigational Site
🇺🇸Morgantown, West Virginia, United States
Pfizer Investigational Site🇺🇸Morgantown, West Virginia, United States