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An Open Label Study That Compares Varenicline to Transdermal Nicotine Patch for Smoking Cessation

This study has been completed.
Sponsor:
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00143325
First received: August 31, 2005
Last updated: June 1, 2007
Last verified: June 2007
History of Changes
  Purpose

Open-label comparison of standard 12-week regimen of varenicline with standard 10-week regimen of transdermal nicotine patch 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: An Open-Label, Multicenter Study With Follow-Up Evaluating the Safety and Efficacy of Varenicline Tartrate in Comparison to Transdermal Nicotine Patch for Smoking Cessation

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Continuous abstinence for the last 4 weeks of varenicline and NRT (Nicotine Replacement Therapy) treatment period

Secondary Outcome Measures:
  • Continuous abstinence last 4 weeks of treatment through Weeks 24 and 52
  • 7-day point prevalence of abstinence: end of treatment, Weeks 24 and 52
  • 4-week Point Prevalence of abstinence at Week 52
  • Long-Term Quit Rate at Weeks 24 and 52
  • Minnesota Nicotine Withdrawal Scale
  • Smoking Effects Inventory

Estimated Enrollment: 730
Study Start Date: January 2005
Study Completion Date: June 2006
  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 15 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 cardiovascular disease in the past 6 months.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00143325

Locations
United States, California
Pfizer Investigational Site
Palo Alto, California, United States
Pfizer Investigational Site
Santa Ana, California, United States
United States, Connecticut
Pfizer Investigational Site
Farmington, Connecticut, United States
United States, Kentucky
Pfizer Investigational Site
Lexington, Kentucky, United States
United States, Massachusetts
Pfizer Investigational Site
Worcester, Massachusetts, United States
United States, Oregon
Pfizer Investigational Site
Portland, Oregon, United States
Belgium
Pfizer Investigational Site
Bruxelles, Belgium
Pfizer Investigational Site
Edegem, Belgium
Pfizer Investigational Site
Gent, Belgium
France
Pfizer Investigational Site
Caen, France
Pfizer Investigational Site
Clermont-Ferrand, France
Pfizer Investigational Site
Limeil Brevannes, France
Pfizer Investigational Site
Limeil-Brevannes, France
Pfizer Investigational Site
Metz CEDEX 01, France
Pfizer Investigational Site
Metz Cedex 1, France
Pfizer Investigational Site
Paris, France
Pfizer Investigational Site
Vandoeuvre les Nancy, France
Netherlands
Pfizer Investigational Site
Amsterdam, Netherlands
Pfizer Investigational Site
Enschede, Netherlands
Pfizer Investigational Site
Maastricht, Netherlands
Pfizer Investigational Site
Zutphen, Netherlands
United Kingdom
Pfizer Investigational Site
London, Surrey, United Kingdom
Pfizer Investigational Site
London, United Kingdom
Pfizer Investigational Site
Nottingham, United Kingdom
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
To obtain contact information for a study center near you, click here.  This link exits the ClinicalTrials.gov site

No publications provided by Pfizer

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

ClinicalTrials.gov Identifier: NCT00143325     History of Changes
Other Study ID Numbers: A3051044
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
Nicotine
Varenicline
Ganglionic Stimulants
Autonomic Agents
Peripheral Nervous System Agents
 Physiological Effects of Drugs
Pharmacologic Actions
Nicotinic Agonists
Cholinergic Agonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on May 16, 2013