Varenicline (Champix®) Special Investigation (Regulatory Post Marketing Commitment Plan)
NCT01061710
ABOUT THIS STUDY
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- Male or Female subjects intend to quit tobacco use who are prescribed varenicline (Champix®) by their Physicians
- Subjects who are prescribed varenicline (Champix®) for the second time within 52 weeks of initial treatment.
Non-participants of varenicline (Champix®) Drug use Investigation protocol A3051109.
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Descriptive Information | ||||
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Brief Title | Varenicline (Champix®) Special Investigation (Regulatory Post Marketing Commitment Plan) | |||
Official Title | Champix Tablets Special Investigation -Retrospective Survey For Subjects Who Have Been Retreated With Champix.-(Regulatory Post Marketing Commitment Plan). | |||
Brief Summary | The purpose of this study is to collect the efficacy and safety information in subjects who have been retreated with varenicline (Champix®) within 52 weeks of initial treatment for their appropriate use in daily practice and are participants for varenicline Drug Use Investigation protocol A3051109 ((NCT# NCT00772941). | |||
Detailed Description | The subjects have been retreated with varenicline within 52 weeks, and subjects have been enrolled to varenicline Drug Use Investigation protocol A3051109. | |||
Study Type | Observational | |||
Study Design | Observational Model: Case-Only Time Perspective: Retrospective | |||
Target Follow-Up Duration | Not Provided | |||
Biospecimen | Not Provided | |||
Sampling Method | Probability Sample | |||
Study Population | The subjects who have been retreated with varenicline in A3051109 (NCT# NCT00772941) within 52 weeks of initial treatment. | |||
Condition | Smoking Cessation | |||
Intervention | Drug: varenicline
Dosage form: tablet 0.5mg, tablet 1mg. The usual adult dosage for oral use is 0.5 mg once daily after eating on Days 1 to 3; 0.5 mg twice daily after eating in the morning and evening on Days 4 to 7, and 1 mg twice daily after eating in the morning and evening on Day 8 and thereafter. The drug should be administered to subjects for 12 weeks. Other Name: Chantix, Champix | |||
Study Groups/Cohorts | varenicline (Champix®)
Subjects who have been retreated with varenicline within 52 weeks and have been enrolled to varenicline protocol A3051109. Intervention: Drug: varenicline | |||
Publications * | Not Provided | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. | ||||
Recruitment Information | ||||
Recruitment Status | Completed | |||
Actual Enrollment | 20 | |||
Original Estimated Enrollment | 100 | |||
Actual Study Completion Date | February 2014 | |||
Actual Primary Completion Date | February 2014 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria | Inclusion Criteria:
Exclusion Criteria: Non-participants of varenicline (Champix®) Drug use Investigation protocol A3051109. | |||
Sex/Gender |
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Ages | Child, Adult, Older Adult | |||
Accepts Healthy Volunteers | No | |||
Contacts | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries | Not Provided | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number | NCT01061710 | |||
Other Study ID Numbers | A3051117 | |||
Has Data Monitoring Committee | No | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement | Not Provided | |||
Responsible Party | Pfizer | |||
Study Sponsor | Pfizer | |||
Collaborators | Not Provided | |||
Investigators |
| |||
PRS Account | Pfizer | |||
Verification Date | January 2015 |