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Varenicline (Champix®) Special Investigation (Regulatory Post Marketing Commitment Plan)

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ClinicalTrials.gov Identifier: NCT01061710
Recruitment Status : Completed
First Posted : February 3, 2010
Results First Posted : February 11, 2015
Last Update Posted : February 11, 2015
Sponsor:
Information provided by (Responsible Party):
Pfizer

Study Type Observational
Study Design Observational Model: Case-Only;   Time Perspective: Retrospective
Condition Smoking Cessation
Intervention Drug: varenicline
Enrollment 20
Recruitment Details  
Pre-assignment Details This survey enrolled those who participated in preceding varenicline Drug Use Investigation protocol A3051109 (NCT00772941) and retreated with varenicline within 52 weeks of initial treatment.
Arm/Group Title Varenicline (Champix®)
Hide Arm/Group Description The usual adult dosage for oral use is as follows: Day 1 through Day 3, 0.5 mg once daily after eating; Day 4 through Day 7, 0.5 mg twice daily after eating in the morning and evening; and Day 8 and thereafter, 1 mg twice daily after eating in the morning and evening. Treatment period was 12 weeks. Participants were retreated within 52 weeks of initial treatment.
Period Title: Overall Study
Started 20
Completed 6
Not Completed 14
Reason Not Completed
Protocol Violation             14
Arm/Group Title Varenicline (Champix®)
Hide Arm/Group Description The usual adult dosage for oral use is as follows: Day 1 through Day 3, 0.5 mg once daily after eating; Day 4 through Day 7, 0.5 mg twice daily after eating in the morning and evening; and Day 8 and thereafter, 1 mg twice daily after eating in the morning and evening. Treatment period was 12 weeks. Participants were retreated within 52 weeks of initial treatment.
Overall Number of Baseline Participants 6
Hide Baseline Analysis Population Description
A total of 20 participants were enrolled in this survey. Of the 20 participants, 14 participants were excluded from the baseline analysis due to a protocol violation.
Age, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 6 participants
<65 years 3
>=65 years 3
Sex/Gender, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 6 participants
Female 0
Male 6
1.Primary Outcome
Title Number of Participants With Treatment-Related Adverse Events (AEs)
Hide Description An AE was any untoward medical occurrence attributed to veranicline in a participant who received veranicline. Treatment related adverse events were evaluated in company with the causal relationship to veranicline.
Time Frame 24 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
The safety analysis population comprised participants who had been enrolled in varenicline protocol A3051109 and retreated with varenicline within 52 weeks of initial treatment.
Arm/Group Title Varenicline (Champix®)
Hide Arm/Group Description:
The usual adult dosage for oral use is as follows: Day 1 through Day 3, 0.5 mg once daily after eating; Day 4 through Day 7, 0.5 mg twice daily after eating in the morning and evening; and Day 8 and thereafter, 1 mg twice daily after eating in the morning and evening. Treatment period was 12 weeks. Participants were retreated within 52 weeks of initial treatment.
Overall Number of Participants Analyzed 6
Measure Type: Number
Unit of Measure: Participants
0
2.Primary Outcome
Title Number of Responders to Varenicline Treatment
Hide Description Number of participants who succeeded in smoking cessation from 12 weeks through 24 weeks of the observation period.
Time Frame 24 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
The efficacy analysis population comprised the participants who had at least one post-baseline efficacy measurement among the safety analysis population.
Arm/Group Title Varenicline (Champix®)
Hide Arm/Group Description:
The usual adult dosage for oral use is as follows: Day 1 through Day 3, 0.5 mg once daily after eating; Day 4 through Day 7, 0.5 mg twice daily after eating in the morning and evening; and Day 8 and thereafter, 1 mg twice daily after eating in the morning and evening. Treatment period was 12 weeks. Participants were retreated within 52 weeks of initial treatment.
Overall Number of Participants Analyzed 6
Measure Type: Number
Unit of Measure: Participants
2
3.Secondary Outcome
Title Number of Treatment-Related Adverse Events (AEs) Unlisted in Japanese Package Insert
Time Frame 24 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
The safety analysis population comprised participants who had been enrolled in varenicline protocol A3051109 and retreated with varenicline within 52 weeks of initial treatment.
Arm/Group Title Varenicline (Champix®)
Hide Arm/Group Description:
The usual adult dosage for oral use is as follows: Day 1 through Day 3, 0.5 mg once daily after eating; Day 4 through Day 7, 0.5 mg twice daily after eating in the morning and evening; and Day 8 and thereafter, 1 mg twice daily after eating in the morning and evening. Treatment period was 12 weeks. Participants were retreated within 52 weeks of initial treatment.
Overall Number of Participants Analyzed 6
Measure Type: Number
Unit of Measure: Participants
0
4.Secondary Outcome
Title Number of Participants With Risk Factors Likely to Affect the Frequency of Treatment-Related Adverse Events (AEs)
Hide Description [Not Specified]
Time Frame 24 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
The safety analysis population comprised participants who had been enrolled in varenicline protocol A3051109 and retreated with varenicline within 52 weeks of initial treatment. Because of the small population size, no risk analyses were performed.
Arm/Group Title Varenicline (Champix®)
Hide Arm/Group Description:
The usual adult dosage for oral use is as follows: Day 1 through Day 3, 0.5 mg once daily after eating; Day 4 through Day 7, 0.5 mg twice daily after eating in the morning and evening; and Day 8 and thereafter, 1 mg twice daily after eating in the morning and evening. Treatment period was 12 weeks. Participants were retreated within 52 weeks of initial treatment.
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
5.Secondary Outcome
Title Number of Participants With Risk Factors Likely to Affect the Proportion of Responders
Hide Description [Not Specified]
Time Frame 24 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
The efficacy analysis population comprised the participants who had at least one post-baseline efficacy measurement among the safety analysis population. Because of the small population size, no risk analyses were performed.
Arm/Group Title Varenicline (Champix®)
Hide Arm/Group Description:
The usual adult dosage for oral use is as follows: Day 1 through Day 3, 0.5 mg once daily after eating; Day 4 through Day 7, 0.5 mg twice daily after eating in the morning and evening; and Day 8 and thereafter, 1 mg twice daily after eating in the morning and evening. Treatment period was 12 weeks. Participants were retreated within 52 weeks of initial treatment.
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame [Not Specified]
Adverse Event Reporting Description The frequency of adverse events during the survey.
 
Arm/Group Title Varenicline (Champix®)
Hide Arm/Group Description The usual adult dosage for oral use is as follows: Day 1 through Day 3, 0.5 mg once daily after eating; Day 4 through Day 7, 0.5 mg twice daily after eating in the morning and evening; and Day 8 and thereafter, 1 mg twice daily after eating in the morning and evening. Treatment period was 12 weeks. Participants were retreated within 52 weeks of initial treatment.
All-Cause Mortality
Varenicline (Champix®)
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Varenicline (Champix®)
Affected / at Risk (%)
Total   0/6 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Varenicline (Champix®)
Affected / at Risk (%)
Total   0/6 (0.00%) 
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.
Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
Results Point of Contact
Name/Title: Pfizer ClinicalTrials.gov Call Center
Organization: Pfizer, Inc.
Phone: 1-800-718-1021
Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01061710     History of Changes
Other Study ID Numbers: A3051117
First Submitted: February 1, 2010
First Posted: February 3, 2010
Results First Submitted: January 27, 2015
Results First Posted: February 11, 2015
Last Update Posted: February 11, 2015