12 Week Evaluation of the Safety and Efficacy of a Flexible Dose 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

NCT00150228

A3051016

Details and patient eligibility

About

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

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind