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Efficacy and Safety of Varenicline in Smokers With Cardiovascular Disease Who Wish to Quit Smoking

This study has been completed.
Sponsor:
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00282984
First received: January 26, 2006
Last updated: August 27, 2009
Last verified: August 2009
History of Changes
Results First Received: February 13, 2009  
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
The study was conducted in outpatients. The target population was cigarette smokers with cardiovascular disease drawn from the communities surrounding the participating clinics.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
714 smokers were randomized (ie, assigned to study treatment), 11 participants were randomized, but not treated. The reasons for participants being randomized, not treated included no longer willing to participate in the study (5 participants), protocol violation (3 participants), lost to follow-up (1 participant), and other (2 participants).

Reporting Groups
  Description
Varenicline (Var) 1 week titration followed by 11 weeks of 1 milligram (mg) twice daily (BID) dosing. Study medication was discontinued at the Week 12 visit and participants' smoking status was followed through the non-treatment period to Week 52.
Placebo (Pbo) 1 week titration followed by 11 weeks of placebo (pbo). Study medication was discontinued at the Week 12 visit and participants' smoking status was followed through the non-treatment period to Week 52.

Participant Flow:   Overall Study
    Varenicline (Var)     Placebo (Pbo)  
STARTED     353     350  
COMPLETED     302     289  
NOT COMPLETED     51     61  
Death                 2                 5  
Adverse Event                 8                 5  
Lack of Efficacy                 0                 2  
Lost to Follow-up                 14                 10  
Withdrawal by Participant                 22                 34  
Participant stopped study medication                 2                 2  
Participant only allowed phone follow-up                 0                 1  
Participant used antipsychosis meds                 0                 1  
lack of motivation                 1                 0  
in prison                 0                 1  
Protocol Violation                 2                 0  



  Baseline Characteristics
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Reporting Groups
  Description
Varenicline (Var) 1 week titration followed by 11 weeks of 1 milligram (mg) twice daily (BID) dosing. Study medication was discontinued at the Week 12 visit and participants' smoking status was followed through the non-treatment period to Week 52.
Placebo (Pbo) 1 week titration followed by 11 weeks of placebo (pbo). Study medication was discontinued at the Week 12 visit and participants' smoking status was followed through the non-treatment period to Week 52.
Total Total of all reporting groups

Baseline Measures
    Varenicline (Var)     Placebo (Pbo)     Total  
Number of Participants  
[units: participants]
 		  353     350     703  
Age  
[units: years]
Mean ± Standard Deviation 		  57.0  ± 8.6     56.0  ± 8.4     56.5  ± 8.5  
Gender  
[units: participants]
 		     
Female     87     63     150  
Male     266     287     553  



  Outcome Measures
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1.  Primary:   Number of Responders With Carbon Monoxide (CO) Confirmed 4-week Continuous Quit Rate (CQR) for Last 4 Weeks of Treatment (Trtmt)   [ Time Frame: weeks 9 through 12 ]
  Show Outcome Measure 1

2.  Secondary:   Number of Responders With Continuous Abstinence (CA) Through Week 52   [ Time Frame: Week 9 through Week 52 ]
  Show Outcome Measure 2

3.  Secondary:   Number of Long-Term Quit Responders   [ Time Frame: Week 9 through Week 52 ]
  Show Outcome Measure 3

4.  Secondary:   Number of Participants With a Seven-Day Point Prevalence of Abstinence at Week 12   [ Time Frame: Week 12 ]
  Show Outcome Measure 4

5.  Secondary:   Number of Participants With a Seven-Day Point Prevalence of Abstinence at Week 24   [ Time Frame: Week 24 ]
  Show Outcome Measure 5

6.  Secondary:   Number of Participants With a Seven-Day Point Prevalence of Abstinence at Week 52   [ Time Frame: Week 52 ]
  Show Outcome Measure 6

7.  Secondary:   Number of Participants With a 4 Week Point Prevalence of Smoking Cessation   [ Time Frame: Week 48 through Week 52 (final 4 weeks of non-treatment period [pd]) ]
  Show Outcome Measure 7

8.  Secondary:   Number of Responders With Continuous Abstinence (CA) Through Week 24   [ Time Frame: Week 9 through Week 24 ]
  Show Outcome Measure 8

9.  Secondary:   Cigarettes Smoked Per Day   [ Time Frame: Day 21 ]
  Show Outcome Measure 9

10.  Secondary:   Number of Long-Term Quit Responders From Week 9 Through Week 24   [ Time Frame: Week 9 through Week 24 ]
  Show Outcome Measure 10


  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
No text entered.  


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
ClinicalTrials.gov Identifier: NCT00282984     History of Changes
Other Study ID Numbers: A3051049
Study First Received: January 26, 2006
Results First Received: February 13, 2009
Last Updated: August 27, 2009
Health Authority: United States: Food and Drug Administration