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Trial record 1 of 1 for:    NCT00143286
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A 52-Week Multicenter Study Evaluating the Safety and Efficacy of Varenicline for the Maintenance of 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: NCT00143286
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 April 2003
Primary Completion Date Not Provided
Current Primary Outcome Measures  ICMJE
 (submitted: June 1, 2007)
Continuous abstinence Weeks 13 -24.
Original Primary Outcome Measures  ICMJE
 (submitted: August 31, 2005)
The primary outcome is continuous abstinence ( CA ) from weeks 13 -24.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 1, 2007)
  • Continuous abstinence Weeks 13-52
  • Long term quit rate at Week 52
  • 7-day Point Prevalence of abstinence at Weeks 24, 52
  • 4-week Point Prevalence of abstinence at Week 52
  • Time to first cigarette post randomization
Original Secondary Outcome Measures  ICMJE
 (submitted: August 31, 2005)
Continuous abstinence week 13-52 Long term quit rate at week 52 Proportion of subjects who successfully quit during the treatment phase And patients who had no more than 6 days of smoking during nontreatment phase
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A 52-Week Multicenter Study Evaluating the Safety and Efficacy of Varenicline for the Maintenance of Smoking Cessation
Official Title  ICMJE A 52-Week Multicenter Study Evaluating the Safety and Efficacy of Varenicline ( CP-526,555) for the Maintenance of Smoking Cessation
Brief Summary The primary purpose of this study is a comparison of abstinence maintenance in subjects randomized to double-blind varenicline or placebo from Weeks 13 -24 in subjects who responded to an intial 12-week open label course of varenicline, with post-treatment follow-up of smoking status to Week 52.
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 *

*   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)
2000
Original Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE March 2005
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

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 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 Canada,   Czech Republic,   Denmark,   Norway,   Sweden,   United Kingdom,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00143286
Other Study ID Numbers  ICMJE A3051035
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