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

Purpose

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	Intervention	Phase
Smoking Cessation	Drug: varenicline (CP-526,555)	Phase III

MedlinePlus related topics:

Smoking Smoking Cessation

ChemIDplus related topics:

Varenicline Varenicline tartrate

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety Study

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

Further study details as provided by Pfizer:

Primary Outcome Measures:

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

Secondary Outcome Measures:

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

Estimated Enrollment:	375
Study Start Date:	October 2003
Estimated Study Completion Date:	March 2005

Eligibility

Ages Eligible for Study:	18 Years to 75 Years
Genders Eligible for Study:	Both
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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00143299

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

Link to ClinicalStudyResults.org Posting This link exits the ClinicalTrials.gov site

Publications indexed to this study:

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.

Study ID Numbers:	A3051037
First Received:	August 31, 2005
Last Updated:	June 1, 2007
ClinicalTrials.gov Identifier:	NCT00143299
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Smoking

Additional relevant MeSH terms:

Habits

ClinicalTrials.gov processed this record on October 10, 2008

Sponsored by:	Pfizer
Information provided by:	Pfizer
ClinicalTrials.gov Identifier:	NCT00143299