12 Week Evaluation of the Safety and Efficacy of a Flexible Dose of CP-526,555 and Placebo for Smoking Cessation

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

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

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.