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

Phase 3

Completed

• Conditions: Smoking Cessation

• Registration Number: NCT00143299
• Lead Sponsor: Pfizer

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2003-10
• Study Completion: 2005-03
• Study First Submitted: 2005-08-31
• Study First Submitted QC: 2005-08-31
• Study First Posted: 2005-09-02
• Status Verified: 2007-06
• Last Update Submitted: 2007-06-01
• Last Update Posted: 2007-06-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 375

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Summarization of safety data in smokers treated with either varenicline or placebo.

Secondary Outcome Measures

Name	Time	Method
Information will be collected for the 7 day point prevalence of smoking cessation.

Trial Locations

Locations (1)

Pfizer Investigational Site; 🇦🇺 Woodville South, South Australia, Australia