Drug Use Investigation Of Varenicline (Regulatory Post Marketing Commitment Plan)
NCT00772941
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Adult Trials: 18+ Years
- Patients need to be administered Varenicline(Champix) in order to be enrolled in the surveillance.
- Patients not administered Varenicline(Champix).
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| Descriptive Information | ||||
|---|---|---|---|---|
| Brief Title | Drug Use Investigation Of Varenicline (Regulatory Post Marketing Commitment Plan) | |||
| Official Title | Drug Use Investigation Of Champix (Regulatory Post Marketing Commitment Plan) | |||
| Brief Summary | The objective of this surveillance is to collect information about 1) adverse drug reaction not expected from the LPD (unknown adverse drug reaction), 2) the incidence of adverse drug reactions in this surveillance, and 3)factors considered to affect the safety and/or efficacy of this drug. | |||
| Detailed Description | All the patients whom an investigator prescribes the first Varenicline(Champix) should be registered consecutively until the number of subjects reaches target number in order to extract patients enrolled into the investigation at random. | |||
| Study Type | Observational | |||
| Study Design | Observational Model: Case-Only Time Perspective: Prospective | |||
| Target Follow-Up Duration | Not Provided | |||
| Biospecimen | Not Provided | |||
| Sampling Method | Probability Sample | |||
| Study Population | The patients whom an investigator involving A3051109 prescribes the Varenicline(Champix). | |||
| Condition | Smoking Cessation | |||
| Intervention | Drug: Varenicline
Champix Tablets 0.5mg or Champix Tablets 1mg, depending on the Investigator prescription. Frequency and duration are according to Package Insert as follows. "The usual adult dosage for oral use is 0.5 mg of varenicline once daily after eating for days 1 to 3, 0.5 mg twice daily after eating in the morning and evening for days 4 to 7, and 1 mg twice daily after eating in the morning and evening on and after day 8. The drug should be administered to patients for 12 weeks." Other Name: Champix, Chantix | |||
| Study Groups/Cohorts | Varenicline
Patients taking Varenicline. 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 | 3939 | |||
| Original Estimated Enrollment | 3000 | |||
| Actual Study Completion Date | December 2012 | |||
| Actual Primary Completion Date | December 2012 (Final data collection date for primary outcome measure) | |||
| Eligibility Criteria | Inclusion Criteria:
Exclusion Criteria:
| |||
| 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 | NCT00772941 | |||
| Other Study ID Numbers | A3051109 | |||
| 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 |
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| PRS Account | Pfizer | |||
| Verification Date | January 2014 | |||