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Clinical Trials/NCT00143299
NCT00143299
Completed
Phase 3

A 52-Week, Double-Blind, Placebo-Controlled, Randomized, Multicenter Study Evaluating the Safety of Varenicline Tartrate ( CP-526,555) for Smoking Cessation

Pfizer1 site in 1 country375 target enrollmentOctober 2003

Overview

Phase
Phase 3
Intervention
Not specified
Conditions
Smoking Cessation
Sponsor
Pfizer
Enrollment
375
Locations
1
Primary Endpoint
Summarization of safety data in smokers treated with either varenicline or placebo.
Status
Completed
Last Updated
18 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
October 2003
End Date
March 2005
Last Updated
18 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Pfizer

Eligibility Criteria

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.

Outcomes

Primary Outcomes

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

Secondary Outcomes

  • Information will be collected for the 7 day point prevalence of smoking cessation.

Study Sites (1)

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