Post Marketing Surveillance Study To Observe Safety And Efficacy Of Champix® Tablets
NCT00483002
Last updated date
ABOUT THIS STUDY
To monitor use in real practice including safety and efficacy of Champix tablets 0.5mg, 1mg
medication for 12 weeks in smokers
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
18 + years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details
- Subjects selected for this study are those who would have been prescribed Champix tablets by the physician according to the subject's condition in usual clinical practice.
Exclusion Criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details
- None
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Advanced Information
| Descriptive Information | ||||
|---|---|---|---|---|
| Brief Title | Post Marketing Surveillance Study To Observe Safety And Efficacy Of Champix® Tablets | |||
| Official Title | Post Marketing Surveillance Study To Observe Safety And Efficacy Of Champix® Tablets | |||
| Brief Summary | To monitor use in real practice including safety and efficacy of Champix tablets 0.5mg, 1mg medication for 12 weeks in smokers | |||
| Detailed Description | No sampling method will be applied to this study. | |||
| Study Type | Observational | |||
| Study Design | Observational Model: Case-Only Time Perspective: Prospective | |||
| Target Follow-Up Duration | Not Provided | |||
| Biospecimen | Not Provided | |||
| Sampling Method | Non-Probability Sample | |||
| Study Population | Healthy smokers | |||
| Condition | Smoking Cessation | |||
| Intervention | Drug: varenicline
As prescribed by physician in usual clinical practice. Other Name: Champix, Chantix, CP-526,555 | |||
| Study Groups/Cohorts | Healthy smokers
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 | 3719 | |||
| Original Enrollment | 4500 | |||
| Actual Study Completion Date | May 2011 | |||
| Actual Primary Completion Date | May 2011 (Final data collection date for primary outcome measure) | |||
| Eligibility Criteria | Inclusion Criteria:
Exclusion Criteria:
| |||
| Sex/Gender |
| |||
| Ages | 18 Years and older (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 | NCT00483002 | |||
| Other Study ID Numbers | A3051083 | |||
| Has Data Monitoring Committee | Yes | |||
| 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 | April 2012 | |||