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

Study Description

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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.

Condition or disease	Intervention/treatment	Phase
Smoking Cessation	Drug: varenicline (CP-526,555)	Phase 3

Study Design

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Study Type :	Interventional (Clinical Trial)
Enrollment :	375 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	Double
Primary Purpose:	Treatment
Official Title:	A 52-Week, Double-Blind, Placebo-Controlled, Randomized, Multicenter Study Evaluating the Safety of Varenicline Tartrate ( CP-526,555) for Smoking Cessation
Study Start Date :	October 2003
Study Completion Date :	March 2005

Arms and Interventions

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Outcome Measures

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :

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

Secondary Outcome Measures :

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

Eligibility Criteria

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Ages Eligible for Study:	18 Years to 75 Years (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Locations

United States, Colorado
Pfizer Investigational Site
Denver, Colorado, United States, 80212
United States, Massachusetts
Pfizer Investigational Site
Milford, Massachusetts, United States, 01757
United States, New Mexico
Pfizer Investigational Site
Albuquerque, New Mexico, United States, 87108
United States, New York
Pfizer Investigational Site
Syracuse, New York, United States, 13210
United States, North Carolina
Pfizer Investigational Site
Charlotte, North Carolina, United States, 28207
United States, Oklahoma
Pfizer Investigational Site
Oklahoma City, Oklahoma, United States, 73103
United States, Pennsylvania
Pfizer Investigational Site
Harleysville, Pennsylvania, United States, 19438
United States, Virginia
Pfizer Investigational Site
Richmond, Virginia, United States, 23249
Australia, South Australia
Pfizer Investigational Site
Woodville South, South Australia, Australia, 5011

Sponsors and Collaborators

Pfizer

Investigators

Study Director:	Pfizer CT.gov Call Center	Pfizer

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Williams KE, Reeves KR, Billing CB Jr, Pennington AM, Gong J. A double-blind study evaluating the long-term safety of varenicline for smoking cessation. Curr Med Res Opin. 2007 Apr;23(4):793-801.

ClinicalTrials.gov Identifier:	NCT00143299 History of Changes
Other Study ID Numbers:	A3051037
First Posted:	September 2, 2005
Last Update Posted:	June 4, 2007
Last Verified:	June 2007

Additional relevant MeSH terms:

Varenicline; Nicotinic Agonists; Cholinergic Agonists; Cholinergic Agents	Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Physiological Effects of Drugs