12 Week Evaluation of the Safety and Efficacy of 4 Dosing Strategies of CP-526,555 and Placebo for Smoking Cessation.
Phase 2
Completed
- Conditions
- Smoking Cessation
- Registration Number
- NCT00150254
- Lead Sponsor
- Pfizer
- Brief Summary
The purpose of the study is to measure the safety and efficacy of four dosing strategies of CP-526,555 for 12 weeks compared with placebo for smoking cessation. Post-treatment follow-up of smoking status to one year from randomization was performed in a non-treatment extension Protocol A3051018
- 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 clinically significant cardiovascular disease
- Uncontrolled hypertension
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method 4 week continuous quit rate (CQR) at Weeks 9-12 and Weeks 4-7
- Secondary Outcome Measures
Name Time Method Continuous abstinence rate from target quit date to end of treatment (Week 12) Carbon monoxide(CO)-confirmed 7-day point prevalence of abstinence at Week 12 Number of cigarettes smoked per day Urge to smoke and withdrawal symptoms assessed by Minnesota Nicotine Withdrawal Scale Rewarding effects of smoking assessed by Smoking Effects Inventory Weight change from baselin
Trial Locations
- Locations (1)
Pfizer Investigational Site
🇺🇸Houston, Texas, United States