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

Pfizer375 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

375

Conditions

Smoking Cessation

Interventions

varenicline (CP-526,555)DRUG

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

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.

Locations (9)

Pfizer Investigational Site

Denver, Colorado, United States

Pfizer Investigational Site

Milford, Massachusetts, United States

Pfizer Investigational Site

Albuquerque, New Mexico, United States

Pfizer Investigational Site

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.

Data from ClinicalTrials.gov

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