Text Size

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

This study has been completed.
Sponsor:
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00143299
First received: August 31, 2005
Last updated: June 1, 2007
Last verified: June 2007
History of Changes
  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:

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
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):

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

ClinicalTrials.gov processed this record on June 17, 2013