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An Open Label Study That Compares Varenicline to Transdermal Nicotine Patch for Smoking Cessation
This study has been completed.
Sponsored by: Pfizer
Information provided by: Pfizer
ClinicalTrials.gov Identifier: NCT00143325
  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 III

MedlinePlus related topics: Quitting Smoking Smoking
Drug Information available for: Varenicline Nicotine polacrilex Nicotine tartrate Varenicline tartrate
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
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

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
Santa Ana, California, United States
Pfizer Investigational Site
Palo Alto, 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
EDEGEM, Belgium
Pfizer Investigational Site
Bruxelles, Belgium
Pfizer Investigational Site
Gent, Belgium
France
Pfizer Investigational Site
Vandoeuvre les Nancy, France
Pfizer Investigational Site
Vandoeuvre Les Nancy, France
Pfizer Investigational Site
Caen, 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
Clermont-Ferrand, France
Netherlands
Pfizer Investigational Site
ZUTPHEN, Netherlands
Pfizer Investigational Site
AMSTERDAM, Netherlands
Pfizer Investigational Site
ENSCHEDE, Netherlands
Pfizer Investigational Site
Maastricht, Netherlands
United Kingdom
Pfizer Investigational Site
London, United Kingdom
Pfizer Investigational Site
Nottingham, United Kingdom
United Kingdom, Surrey
Pfizer Investigational Site
London, Surrey, United Kingdom
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

To obtain contact information for a study center near you, click here.  This link exits the ClinicalTrials.gov site
Link to ClinicalStudyResults.org Posting  This link exits the ClinicalTrials.gov site

Publications indexed to this study:
Aubin HJ, Bobak A, Britton JR, Oncken C, Billing CB Jr, Gong J, Williams KE, Reeves KR. Varenicline versus transdermal nicotine patch for smoking cessation: Results from a randomised, open-label trial. Thorax. 2008 Feb 8; [Epub ahead of print]

Study ID Numbers: A3051044
Study First Received: August 31, 2005
Last Updated: June 1, 2007
ClinicalTrials.gov Identifier: NCT00143325  
Health Authority: United States: Food and Drug Administration

Study placed in the following topic categories:
Nicotine polacrilex
Smoking
Nicotine

Additional relevant MeSH terms:
Habits

ClinicalTrials.gov processed this record on January 16, 2009



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