A 52-Week Multicenter Study Evaluating the Safety and Efficacy of Varenicline for the Maintenance of Smoking Cessation

Pfizer2,000 enrolled

Overview

The primary purpose of this study is a comparison of abstinence maintenance in subjects randomized to double-blind varenicline or placebo from Weeks 13 -24 in subjects who responded to an intial 12-week open label course of varenicline, with post-treatment follow-up of smoking status to Week 52.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

2,000

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 cardiovascular disease in the past 6 months.

Locations (24)

Pfizer Investigational Site

Santa Ana, California, United States

Outcomes

Primary Outcomes

Continuous abstinence Weeks 13 -24.

Secondary Outcomes

Continuous abstinence Weeks 13-52

Long term quit rate at Week 52

7-day Point Prevalence of abstinence at Weeks 24, 52

4-week Point Prevalence of abstinence at Week 52

Time to first cigarette post randomization

Data from ClinicalTrials.gov

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