Varenicline (Champix®) Special Investigation (Regulatory Post Marketing Commitment Plan)
NCT01061710
Last updated date
ABOUT THIS STUDY
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).
FOR MORE INFORMATION
Contact a representative by phone, email, or visiting the study website. Please see the references below:
By phone
Pfizer Clinical Trials Contact Center
1-800-718-1021
Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Smoking Cessation
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
Adult Trials: 18+ Years
0 +
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details
- 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.
Exclusion Criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details
Non-participants of varenicline (Champix®) Drug use Investigation protocol A3051109.
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Advanced Information
| 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 | |||