A Twelve-Week Study of Varenicline for Safety and Efficacy in Comparison With Placebo and Zyban for Smoking Cessation

Pfizer

Status and phase: Completed; Phase 3

Conditions: Smoking Cessation

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

Study type: Interventional

Funder types: Industry

Identifiers

NCT00141206

A3051028

Details and patient eligibility

About

The primary purpose of this study is to evaluate the safety and efficacy of varenicline given for a twelve week treatment period in comparison with placebo and Zyban for smoking cessation.

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Subjects must have smoked an average of at least 10 cigarettes per day during the past year and over the month prior to the screening visit, with no period of abstinence greater than 3 months in the past year.

Exclusion criteria

• Subjects who have used bupropion (Zyban, or Wellbutrin) previously.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind