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Trial record 1 of 1 for:    NCT00691483
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Randomized Study Comparing the Efficacy and Safety of Varenicline Tartrate to Placebo in Smoking Cessation When Subjects Are Allowed to Set Their Own Quit Date

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ClinicalTrials.gov Identifier: NCT00691483
Recruitment Status : Completed
First Posted : June 5, 2008
Results First Posted : September 30, 2010
Last Update Posted : November 20, 2015
Sponsor:
Information provided by:
Pfizer

Tracking Information
First Submitted Date  ICMJE June 3, 2008
First Posted Date  ICMJE June 5, 2008
Results First Submitted Date  ICMJE September 9, 2010
Results First Posted Date  ICMJE September 30, 2010
Last Update Posted Date November 20, 2015
Study Start Date  ICMJE September 2008
Actual Primary Completion Date September 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 9, 2010)
Percentage of Participants With 4-week Continuous Abstinence (CA) [ Time Frame: Week 9 through Week 12 ]
The percentage of participants who reported complete abstinence from cigarette smoking and other nicotine use (on the Nicotine Use Inventory) and who did not have carbon monoxide (CO) >10 parts per million (ppm) at any visits Week 9 through Week 12. A participant was considered a responder if they met the following criterion: said they had not smoked or used nicotine products 'since the last visit' and did not have CO >10 ppm.
Original Primary Outcome Measures  ICMJE
 (submitted: June 3, 2008)
4-week continuous abstinence rate (CAR) for Weeks 9-12 [ Time Frame: wk 9-12 ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 9, 2010)
  • Percentage of Participants With Continuous Abstinence (CA) From Smoking Weeks 9-24 [ Time Frame: Week 9 through Week 24 ]
    Percentage of participants with CA from cigarette smoking and other nicotine-containing (treatment phase) or tobacco (non-treatment phase) products use, who did not have CO >10 ppm at any visits Week 9 through Week 24. A participant was considered a responder if they met the following criterion: said they had not smoked or used nicotine products 'since the last visit' and did not have CO >10 ppm.
  • Percentage of Participants With Long Term Quit Through Week 24 [ Time Frame: Week 9 through Week 24 ]
    Responder for the primary endpoint of CA from Week 9 through Week 12 and who had no more than 6 days of smoking during the non-treatment phase of the study. For Weeks 13, 16, 20, and 24, long term quit was determined by CO-confirmed in-clinic visit.
  • Percentage of Participants With 7-day Point Prevalence of Nonsmoking (Smoking Cessation) [ Time Frame: Week 12 and Week 24 ]
    Percentage of participants with complete abstinence from cigarette smoking or other nicotine-containing (treatment phase) or tobacco (non-treatment phase) products use for the 7 days prior to Week 12 and Week 24, respectively, who did not have CO >10 ppm at any visits. CO-confirmed in-clinic visit.
  • Percentage of Participants With 4-week Point Prevalence of Nonsmoking [ Time Frame: Week 24 ]
    Percentage of participants with complete abstinence from cigarette smoking or use of tobacco products for the 4 weeks prior to Week 24 who did not have CO >10 ppm at any visits.
Original Secondary Outcome Measures  ICMJE
 (submitted: June 3, 2008)
  • Continuous abstinence (CA) from smoking from Week 9 through Week 24 [ Time Frame: wk 9-24 ]
  • Long Term Quit Rate (LTQR) through Week 24 [ Time Frame: wk 9-24 ]
  • 7-day point prevalence of nonsmoking at Weeks 12 and 24 [ Time Frame: wks 12, 24 ]
  • 4-week point prevalence of nonsmoking at Week 24 [ Time Frame: wk 24 ]
  • Change in Fagerström Test for Nicotine Dependence (FTND) from baseline to day of first quit attempt [ Time Frame: baseline to first quit attempt ]
Current Other Pre-specified Outcome Measures
 (submitted: September 9, 2010)
Change From Baseline in Fagerström Test for Nicotine Dependence (FTND) to Day of First Quit Attempt (FQA) Through Week 5 by Smoking Status at Weeks 9-12 [ Time Frame: Baseline through Week 5 ]
Change in nicotine dependence from baseline to the date of the FQA within the first 5 weeks. FTND was designed to provide an ordinal measure of nicotine dependence related to cigarette smoking. It contains items that evaluate the quantity of cigarette consumption, the compulsion to use, and dependence. The FTND contains 4 yes-no and 2 multiple choice questions and can be used in a self-report format. The items on FTND are scored 0 to 3 for multiple choice items, the items are summed to yield a total score of 0-10 (0=minimum nicotine dependence; 10=maximum nicotine dependence).
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Randomized Study Comparing the Efficacy and Safety of Varenicline Tartrate to Placebo in Smoking Cessation When Subjects Are Allowed to Set Their Own Quit Date
Official Title  ICMJE A Phase 4, Prospective, Multi-National, Randomized, Double-Blind, Placebo-Controlled Study To Evaluate Smoking Cessation With Varenicline Tartrate Compared With Placebo In The Setting Of Patient Self-Selected (Flexible) Quit Date
Brief Summary The hypothesis is that varenicline will be effective (compared with placebo) for smoking cessation when subjects are allowed to set their own quit date within the first 5 weeks of treatment.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Smoking Cessation
Intervention  ICMJE
  • Drug: placebo
    placebo tablet taken orally twice daily for 12 weeks
  • Drug: varenicline
    varenicline tablets, 1 mg taken orally twice daily for 12 weeks
    Other Name: Chantix, Champix
Study Arms  ICMJE
  • Placebo Comparator: placebo
    Intervention: Drug: placebo
  • Experimental: varenicline
    Intervention: Drug: varenicline
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
Actual Enrollment  ICMJE
 (submitted: December 17, 2009)
659
Original Estimated Enrollment  ICMJE
 (submitted: June 3, 2008)
652
Actual Study Completion Date  ICMJE December 2009
Actual Primary Completion Date September 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Men and women
  • 18 to 75 yrs old
  • Motivated to stop smoking
  • Smoke at least 10 cigarettes/day

Exclusion Criteria:

  • Active psychiatric disease
  • Severe or unstable cardiovascular or pulmonary disease
  • Current or recent treatment to stop smoking
  • Previous use of varenicline
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 Argentina,   Brazil,   Canada,   China,   Czech Republic,   France,   Germany,   Hungary,   Italy,   Korea, Republic of,   Mexico,   Taiwan,   United Kingdom,   United States
Removed Location Countries Poland
 
Administrative Information
NCT Number  ICMJE NCT00691483
Other Study ID Numbers  ICMJE A3051095
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Director, Clinical Trial Disclosure Group, Pfizer, Inc.
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Pfizer CT.gov Call Center Pfizer
PRS Account Pfizer
Verification Date October 2015

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