A Twelve-Week Study of Varenicline for Safety and Efficacy in Comparison With Placebo and Zyban for Smoking Cessation

This study has been completed.
Sponsor:
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00143364
First received: August 31, 2005
Last updated: June 1, 2007
Last verified: June 2007
  Purpose

The primary purpose of this study is to evaluate the safety and efficacy of varenicline given for a twelve week treatment period in comparison with placebo and Zyban for smoking cessation.


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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: A Twelve-Week, Double-Blind, Placebo-Controlled, Randomized, Multicenter Study With Follow-up Evaluating the Safety and Efficacy of Varenicline Tartrate ( CP-526,555) in Comparison to Zyban for Smoking Cessation

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • 4 week Continuous Quit Rate ( 4 week CQR ) for Weeks 9 -12.

Secondary Outcome Measures:
  • Continuous abstinence Weeks 9-52
  • Long-term Quit Rate Week 52
  • Continuous abstinence Weeks 9 -24
  • 7-day Point Prevalence Abstinence Weeks 12, 24, and 52
  • 4-week Point Prevalence Abstinence at Week 52
  • Minnesota Nicotine Withdrawal Scale
  • Brief Questionnaire of Smoking Urges
  • Smoking Effects Inventory
  • Change from baseline in bodyweight

Estimated Enrollment: 1005
Study Start Date: June 2003
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 who have used bupropion (Zyban or Wellbutrin) previously.
  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: NCT00143364

Locations
United States, California
Pfizer Investigational Site
Palo Alto, California, United States
Pfizer Investigational Site
San Diego, California, United States
United States, Colorado
Pfizer Investigational Site
Denver, Colorado, United States
United States, Florida
Pfizer Investigational Site
Pembroke Pines, Florida, United States
United States, Indiana
Pfizer Investigational Site
Indianapolis, Indiana, United States
United States, Maine
Pfizer Investigational Site
Portland, Maine, United States
United States, Massachusetts
Pfizer Investigational Site
Boston, Massachusetts, United States
United States, Minnesota
Pfizer Investigational Site
Albert Lea, Minnesota, United States
Pfizer Investigational Site
Rochester, Minnesota, United States
United States, New York
Pfizer Investigational Site
New York, New York, United States
Pfizer Investigational Site
Rochester, New York, United States
United States, Rhode Island
Pfizer Investigational Site
Providence, Rhode Island, United States
United States, Tennessee
Pfizer Investigational Site
Nashville, Tennessee, United States
United States, Wisconsin
Pfizer Investigational Site
Madison, Wisconsin, United States
Pfizer Investigational Site
Milwaukee, Wisconsin, United States
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided by Pfizer

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00143364     History of Changes
Other Study ID Numbers: A3051036
Study First Received: August 31, 2005
Last Updated: June 1, 2007
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
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 September 18, 2014