Post Marketing Surveillance Study To Observe Safety And Efficacy Of Champix® Tablets

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT00483002
First received: June 5, 2007
Last updated: April 11, 2012
Last verified: April 2012
Results First Received: April 11, 2012  
Study Type: Observational
Study Design: Observational Model: Case-Only;   Time Perspective: Prospective
Condition: Smoking Cessation
Intervention: Drug: varenicline

  Participant Flow
  Hide Participant Flow

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 Varenicline tartrate tablets 0.5 milligram (mg) or 1 mg administered as per investigator’s discretion for 12 weeks.

Participant Flow:   Overall Study
    Varenicline  
STARTED     3719  
COMPLETED     1165  
NOT COMPLETED     2554  
Adverse Event                 68  
Lack of Efficacy                 555  
Lost to Follow-up                 962  
Unknown                 2  
Unspecified                 967  



  Baseline Characteristics
  Hide Baseline Characteristics

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.
No text entered.

Reporting Groups
  Description
Varenicline Varenicline tartrate tablets 0.5 milligram (mg) or 1 mg administered as per investigator’s discretion for 12 weeks.

Baseline Measures
    Varenicline  
Number of Participants  
[units: participants]
  3719  
Age  
[units: Years]
Mean ± Standard Deviation
  49.4  ± 11.7  
Gender  
[units: Participants]
 
Female     340  
Male     3379  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Percentage of Participants With 7-day Point Prevalence From Week 3 to Less Than Week 7   [ Time Frame: Week 3 through Week 7 ]

2.  Primary:   Percentage of Participants With 7-day Point Prevalence From Week 7 to Less Than Week 11   [ Time Frame: Week 7 through Week 11 ]

3.  Primary:   Percentage of Participants With 7-day Point Prevalence for at Least Week 11   [ Time Frame: At least Week 11 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
  Hide 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
Planned observation time points at 4, 8 and 12 weeks were reported as from week 3 to less than week 7, from week 7 to less than week 11, at least week 11. As this is non-interventional study it is likely that adverse events had been under reported.


  More Information
  Hide More Information

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


No publications provided


Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT00483002     History of Changes
Other Study ID Numbers: A3051083
Study First Received: June 5, 2007
Results First Received: April 11, 2012
Last Updated: April 11, 2012
Health Authority: Korea: Food and Drug Administration