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).
- 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.
Questions about a trial? Call or email to reach a Pfizer Clinical Trial Contact Center Representative
| Descriptive Information | ||||
|---|---|---|---|---|
| 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 |
| |||
| 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 | |||
Contact a representative by phone, email, or visiting the study website. Please see the references below:
Pfizer Clinical Trials Contact Center
1-800-718-1021
