An Investigation of Effectiveness and Safety of Varenicline Tartrate in Helping People Quit Smoking

Pfizer

Status and phase: Completed; Phase 3

Conditions: Smoking Cessation

Treatments: Drug: Placebo; Drug: Varenicline tartrate

Study type: Interventional

Funder types: Industry

Identifiers

NCT00371813

A3051055

Details and patient eligibility

About

To investigate safety and efficacy of varenicline tartrate in helping people quit smoking

Enrollment: 334 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Current cigarette smokers between the ages of 18 and 75 years, who are motivated to stop smoking

Exclusion criteria

• Patients currently suffering from depression, or have been diagnosed with depression in the last 12 months, or subjects with past or present history of psychosis, panic disorder, or bipolar disorder
• Any subject with known severe chronic obstructive pulmonary disease (COPD)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind