12 Week Evaluation of the Safety and Efficacy of a Flexible Dose of CP-526,555 and Placebo for Smoking Cessation
Information source: Pfizer
Information obtained from ClinicalTrials.gov on October 19, 2007
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Smoking Cessation
Intervention: CP-526,555 (varenicline) (Drug)
Phase: Phase 2
Status: Completed
Sponsored by: Pfizer Official(s) and/or principal investigator(s):
Pfizer CT.gov Call Center, Study Director, Affiliation: Pfizer
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
Clinical Details
Official title:
A Twelve-Week Double-Blind, Placebo-Controlled, Randomized, Multicenter Study Evaluating the Safety and Efficacy of a Flexible-Dosing Strategy for CP-526,555 ( 0.5 mg to 2.0 mg Total Daily Dose ) in Smoking Cessation
Study design: Interventional, Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Primary outcome: 4-week continuous quit rate (CQR) at Weeks 4-7 and 9-12 .
Secondary outcome: Continuous abstinence rate from target quit date to end of treatment (Week 12)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 baseline
Eligibility
Minimum age: 18 Years.
Maximum age: 65 Years.
Gender(s): Both.
Criteria:
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.
Locations and Contacts
Pfizer Investigational Site, LEXINGTON, Kentucky, United States
Pfizer Investigational Site, Albert Lea, Minnesota, United States
Pfizer Investigational Site, Rochester, Minnesota, United States
Pfizer Investigational Site, Philadelphia, Pennsylvania, United States
Pfizer Investigational Site, PHILADELPHIA, Pennsylvania, United States
Pfizer Investigational Site, PROVIDENCE, Rhode Island, United States
Pfizer Investigational Site, La Crosse, Wisconsin, United States
Pfizer Investigational Site, MADISON, Wisconsin, United States
Additional Information
To obtain contact information for a study center near you, click here. Link to ClinicalStudyResults.org Posting
Starting date:
December 2001
Ending date: September 2002
Last updated: May 31, 2007
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