A 52-Week Placebo-Controlled Study Evaluating the Safety of Varenicline

Pfizer

Status and phase: Completed; Phase 3

Conditions: Smoking Cessation

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

Study type: Interventional

Funder types: Industry

Identifiers

NCT00143299

A3051037

Details and patient eligibility

About

The primary purpose of this study is to obtain safety information on cigarette smokers treated with 52 weeks of varenicline regardless of smoking status.

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 with clinically significant, recent cardiovascular disease.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind