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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00143325
Recruitment Status : Completed
First Posted : September 2, 2005
Last Update Posted : June 4, 2007
Information provided by:

Brief Summary:
Open-label comparison of standard 12-week regimen of varenicline with standard 10-week regimen of transdermal nicotine patch for smoking cessation.

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

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Study Type : Interventional  (Clinical Trial)
Enrollment : 730 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
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
Study Start Date : January 2005
Actual Study Completion Date : June 2006

Resource links provided by the National Library of Medicine

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

Secondary Outcome Measures :
  1. Continuous abstinence last 4 weeks of treatment through Weeks 24 and 52
  2. 7-day point prevalence of abstinence: end of treatment, Weeks 24 and 52
  3. 4-week Point Prevalence of abstinence at Week 52
  4. Long-Term Quit Rate at Weeks 24 and 52
  5. Minnesota Nicotine Withdrawal Scale
  6. Smoking Effects Inventory

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00143325

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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
Pfizer Investigational Site
Bruxelles, Belgium
Pfizer Investigational Site
Edegem, Belgium
Pfizer Investigational Site
Gent, Belgium
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
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
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Study Director: Pfizer CT.gov Call Center Pfizer
Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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ClinicalTrials.gov Identifier: NCT00143325    
Other Study ID Numbers: A3051044
First Posted: September 2, 2005    Key Record Dates
Last Update Posted: June 4, 2007
Last Verified: June 2007
Additional relevant MeSH terms:
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Nicotinic Agonists
Cholinergic Agonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs