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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
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
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

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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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 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 
Overall Participants Analyzed 
[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 ]

2.  Secondary:   Number of Participants With Continuous Abstinence   [ Time Frame: Weeks 9 through 24 ]

3.  Secondary:   Number of Participants With Seven-day Point Prevalence of Abstinence   [ Time Frame: Week 12 and 24 ]


  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.govCallCenter@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: 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