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Trial record 1 of 1 for:    NCT00143325
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An Open Label Study That Compares Varenicline to Transdermal Nicotine Patch for Smoking Cessation

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ClinicalTrials.gov Identifier: NCT00143325
Recruitment Status : Completed
First Posted : September 2, 2005
Last Update Posted : June 4, 2007
Sponsor:
Information provided by:
Pfizer

Tracking Information
First Submitted Date  ICMJE August 31, 2005
First Posted Date  ICMJE September 2, 2005
Last Update Posted Date June 4, 2007
Study Start Date  ICMJE January 2005
Primary Completion Date Not Provided
Current Primary Outcome Measures  ICMJE
 (submitted: June 1, 2007)
Continuous abstinence for the last 4 weeks of varenicline and NRT (Nicotine Replacement Therapy) treatment period
Original Primary Outcome Measures  ICMJE
 (submitted: August 31, 2005)
  • 4 week continuous quit rate ( 4 week CQR ) at the end of the study treatment
  • i.e. week 12 for varenicline and week 11 for NRT.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 1, 2007)
  • 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
Original Secondary Outcome Measures  ICMJE
 (submitted: August 31, 2005)
  • Continuous abstinence rate for last 4 weeks of treatment for weeks 24 & 52 visit
  • 1 week point prevalence at the end of study treatment and at week 24 and 52
  • Long-Term Quit Rate at week 24 and 52
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE An Open Label Study That Compares Varenicline to Transdermal Nicotine Patch for Smoking Cessation
Official Title  ICMJE 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
Brief Summary Open-label comparison of standard 12-week regimen of varenicline with standard 10-week regimen of transdermal nicotine patch for smoking cessation.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Condition  ICMJE Smoking Cessation
Intervention  ICMJE Drug: varenicline (CP-526,555)
Study Arms  ICMJE Not Provided
Publications * 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 Aug;63(8):717-24. doi: 10.1136/thx.2007.090647. Epub 2008 Feb 8.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Enrollment  ICMJE
 (submitted: August 31, 2005)
730
Original Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE June 2006
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Belgium,   France,   Netherlands,   United Kingdom,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00143325
Other Study ID Numbers  ICMJE A3051044
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Not Provided
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Pfizer CT.gov Call Center Pfizer
PRS Account Pfizer
Verification Date June 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP