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 3


Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety Study Intervention Model: Parallel Assignment Masking: Double-Blind 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

Resource links provided by NLM:

MedlinePlus related topics: Quitting Smoking Smoking

Drug Information available for: Varenicline Varenicline tartrate

U.S. FDA Resources

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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

No publications provided by Pfizer

Additional 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
Study First Received:	August 31, 2005
Last Updated:	June 1, 2007
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:


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

ClinicalTrials.gov processed this record on March 03, 2015