12 Week Evaluation of the Safety and Efficacy of 4 Dosing Strategies 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

NCT00150254

A3051007

Details and patient eligibility

About

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

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind