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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

This study has been completed.
Sponsor:
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00691483
First received: June 3, 2008
Last updated: October 16, 2015
Last verified: October 2015
Results First Received: September 9, 2010  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator);   Primary Purpose: Treatment
Condition: Smoking Cessation
Interventions: Drug: placebo
Drug: varenicline

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Varenicline Varenicline 0.5 milligrams (mg) administered once daily (QD) for the first 3 days followed by 0.5 mg varenicline twice daily (BID) for the next 4 days, then 1 mg varenicline BID for the remaining 11 weeks (treatment phase). Blinded study drug was discontinued at the Week 12 visit and was followed by a non-treatment phase to Week 24.
Placebo Placebo matched to varenicline.

Participant Flow:   Overall Study
    Varenicline   Placebo
STARTED   493   166 
Received Treatment   486   165 
COMPLETED   425 [1]   141 
NOT COMPLETED   68   25 
Adverse Event                14                6 
Lost to Follow-up                17                10 
Withdrawal by Subject                24                7 
Other known cause                6                1 
Randomized by not treated                7                1 
[1] Completed refers to completion of the study.



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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Reporting Groups
  Description
Varenicline Varenicline 0.5 mg administered QD for the first 3 days followed by 0.5 mg varenicline BID for the next 4 days, then 1 mg varenicline BID for the remaining 11 weeks (treatment phase). Blinded study drug was discontinued at the Week 12 visit and was followed by a non-treatment phase to Week 24.
Placebo Placebo matched to varenicline.
Total Total of all reporting groups

Baseline Measures
   Varenicline   Placebo   Total 
Overall Participants Analyzed 
[Units: Participants]
 486   165   651 
Age, Customized 
[Units: Participants]
     
Between 18 and 44 years   248   93   341 
Between 45 and 64 years   209   64   273 
>= 65 years   29   8   37 
Gender 
[Units: Participants]
     
Female   193   66   259 
Male   293   99   392 


  Outcome Measures
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1.  Primary:   Percentage of Participants With 4-week Continuous Abstinence (CA)   [ Time Frame: Week 9 through Week 12 ]

2.  Secondary:   Percentage of Participants With Continuous Abstinence (CA) From Smoking Weeks 9-24   [ Time Frame: Week 9 through Week 24 ]

3.  Secondary:   Percentage of Participants With Long Term Quit Through Week 24   [ Time Frame: Week 9 through Week 24 ]

4.  Secondary:   Percentage of Participants With 7-day Point Prevalence of Nonsmoking (Smoking Cessation)   [ Time Frame: Week 12 and Week 24 ]

5.  Secondary:   Percentage of Participants With 4-week Point Prevalence of Nonsmoking   [ Time Frame: Week 24 ]

6.  Other Pre-specified:   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 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Pfizer ClinicalTrials.gov Call Center
Organization: Pfizer, Inc.
phone: 1-800-718-1021
e-mail: ClinicalTrials.gov_Inquiries@pfizer.com


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer, Inc.
ClinicalTrials.gov Identifier: NCT00691483     History of Changes
Other Study ID Numbers: A3051095
Study First Received: June 3, 2008
Results First Received: September 9, 2010
Last Updated: October 16, 2015
Health Authority: United States: Food and Drug Administration