12 Week Evaluation of the Safety and Efficacy of a Flexible Dose of CP-526,555 and Placebo for Smoking Cessation
Phase 2
Completed
- Conditions
- Smoking Cessation
- Registration Number
- NCT00150228
- Lead Sponsor
- Pfizer
- Brief Summary
The purpose of the study was to measure the safety and efficacy of a 12-week flexible dosing strategy of CP-526,555 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 A3051019
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 300
Inclusion Criteria
- Subjects must have smoked an average of at least ten cigarettes per day during the past year
- No period of abstinence greater than three months in the past year
Exclusion Criteria
- Subjects with history of clinically significant cardiovascular disease
- Subjects with uncontrolled hypertension.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method 4-week continuous quit rate (CQR) at Weeks 4-7 and 9-12 .
- Secondary Outcome Measures
Name Time Method Number of cigarettes smoked per day Urge to smoke and withdrawal symptoms assessed by Minnesota Nicotine Withdrawal Scale 7-day point prevalence of abstinence at Week 12 Continuous abstinence rate from target quit date to end of treatment (Week 12) Rewarding effects of smoking assessed by Smoking Effects Inventory weight change from baseline
Trial Locations
- Locations (1)
Pfizer Investigational Site
🇺🇸Madison, Wisconsin, United States