Eligibility criteria
Condition
Over Active Bladder
Sex
Females and Males
Age
18 + years
Inclusion criteria
Show details
- Over-active bladder
- Prescribed with Fesoterodine
Exclusion criteria
Show details
- Hypersensitivity
- Urinary retention
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Post Marketing Surveillance Of Fesoterodine In Filipino Patients With Over Active Bladder
NCT01260311
Last updated on October 13, 2019
About this Study
This is an observational study and will determine the safety profile of fesoterodine in Filipino patients prescribed the drug. This is in compliance with the requirements of the Philippine Food and Drug Administration.
NCT01260311
Pfizer
Completed
Post Marketing Surveillance Of Fesoterodine In Filipino Patients With Over Active Bladder
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Questions about a trial? Call or email to reach a Pfizer Clinical Trial Contact Center Representative
| Descriptive Information | ||||
|---|---|---|---|---|
| Brief Title | Post Marketing Surveillance Of Fesoterodine In Filipino Patients With Over Active Bladder | |||
| Official Title | Post Marketing Surveillance To Assess The Safety And Efficacy Of Fesoterodine (Toviaz) On Filipino Patients Diagnosed With Over-Active Bladder | |||
| Brief Summary | This is an observational study and will determine the safety profile of fesoterodine in Filipino patients prescribed the drug. This is in compliance with the requirements of the Philippine Food and Drug Administration. | |||
| Detailed Description | Sampling method is not applicable in this study. Only patients prescribed Fesoterodine will be enrolled. | |||
| Study Type | Observational | |||
| Study Design | Observational Model: Cohort Time Perspective: Prospective | |||
| Target Follow-Up Duration | Not Provided | |||
| Biospecimen | Not Provided | |||
| Sampling Method | Non-Probability Sample | |||
| Study Population | Patients diagnosed with Over-active bladder | |||
| Condition | Over Active Bladder | |||
| Intervention | Drug: Fesoterodine Any dose of Fesoterodine Other Name: Toviaz | |||
| Study Groups/Cohorts | Patients prescribed with Fesoterodine Patients diagnosed with Over-active bladder and prescribed with fesoterodine. Intervention: Drug: Fesoterodine | |||
| 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 | 508 | |||
| Original Estimated Enrollment | 3000 | |||
| Actual Study Completion Date | October 2013 | |||
| Actual Primary Completion Date | October 2013 (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 | Philippines | |||
| Removed Location Countries | ||||
| Administrative Information | ||||
| NCT Number | NCT01260311 | |||
| Other Study ID Numbers | A0221085 | |||
| 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 | September 2014 | |||
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