12 Week Evaluation of the Safety and Efficacy of 3 Doses of CP-526,555 and Placebo for Smoking Cessation

Pfizer

Status and phase: Completed; Phase 2

Conditions: Smoking Cessation

Treatments: Drug: CP-526,555 (varenicline)

Study type: Interventional

Funder types: Industry

Identifiers

NCT00139750

A3051046

Details and patient eligibility

About

The purpose of the study is to examine the safety and efficacy and dose-response relationship of three doses of CP-526,555 for 12 weeks compared with placebo for smoking cessation; including post-treatment follow-up of smoking status to one year from randomization. A small satellite protocol (A3051048) investigated safety of a second course of therapy in subjects who did not quit.

Sex: All

Ages: 20 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Cigarette smokers who are motivated to stop smoking and have smoked an average of at least 10 cigarettes per day

Exclusion criteria

• Subjects who have used a nicotine replacement product within 30 days of the study screening visit or intend to use it during the study.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind