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Assessment of Safety and Efficacy of Varenicline in Patients That Wish to Stop Smoking

This study has been completed.
Sponsor:
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00594204
First received: January 3, 2008
Last updated: July 14, 2010
Last verified: July 2010
History of Changes
Results First Received: May 27, 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: varenicline tartrate (CP-526, 555-18)
Drug: Placebo

  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 0.5 mg once daily (QD) for 3 days + 0.5 mg twice a day (BID) for 4 days, and then 1 mg BID for 11 weeks
Placebo matching placebo following the same treatment schema as the varenicline group

Participant Flow:   Overall Study
    Varenicline     Placebo  
STARTED     394     199  
Received Treatment     390     198  
COMPLETED     336     154  
NOT COMPLETED     58     45  
Adverse Event                 15                 3  
Lost to Follow-up                 9                 5  
Withdrawal by Subject                 23                 29  
Unspecified                 4                 3  
Lack of Efficacy                 3                 4  
Randomized but not treated                 4                 1  



  Baseline Characteristics
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Reporting Groups
  Description
Varenicline 0.5 mg once daily (QD) for 3 days + 0.5 mg twice a day (BID) for 4 days, and then 1 mg BID for 11 weeks
Placebo matching placebo following the same treatment schema as the varenicline group
Total Total of all reporting groups

Baseline Measures
    Varenicline     Placebo     Total  
Number of Participants  
[units: participants]
 		  390     198     588  
Age, Customized  
[units: years]
 		     
< 55     334     164     498  
55 - 65     49     28     77  
> 65     7     6     13  
Gender  
[units: participants]
 		     
Female     165     68     233  
Male     225     130     355  



  Outcome Measures
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1.  Primary:   Number of Participants With 4-week Continuous Abstinence   [ Time Frame: Weeks 9 through 12 ]
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2.  Secondary:   Number of Participants With Continuous Abstinence   [ Time Frame: Weeks 9 through 24 ]
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3.  Secondary:   Number of Participants With Seven-day Point Prevalence of Abstinence   [ Time Frame: Week 12 and 24 ]
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  Serious Adverse Events
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  Other Adverse Events
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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.


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


No publications provided by Pfizer

Publications automatically indexed to this study:


Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer Inc
ClinicalTrials.gov Identifier: NCT00594204     History of Changes
Other Study ID Numbers: A3051080
Study First Received: January 3, 2008
Results First Received: May 27, 2010
Last Updated: July 14, 2010
Health Authority: Brazil: National Committee of Ethics in Research
Brazil: National Health Surveillance Agency