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

Phase 3

Completed

• Conditions: Smoking Cessation

• Registration Number: NCT00371813
• Lead Sponsor: Pfizer

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2006-08-31
• Study First Submitted QC: 2006-08-31
• Study Start: 2006-09
• Study First Posted: 2006-09-04
• Study Completion: 2007-06
• Status Verified: 2015-04
• Last Update Submitted: 2015-04-21
• Last Update Posted: 2015-04-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 334

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
To compare 12 weeks of treatment with varenicline 1 mg BID to placebo for smoking cessation, and to evaluate continuous abstinence from smoking for 12 weeks after the treatment period.

Secondary Outcome Measures

Name	Time	Method
To gather safety data for 12 weeks of treatment with varenicline 1 mg BID or placebo followed by 12 weeks of non-treatment follow-up.

Trial Locations

Locations (1)

Pfizer Investigational Site; 🇹🇭 Chiang Mai, Thailand