Post Marketing Surveillance Of Fesoterodine In Filipino Patients With Over Active Bladder
NCT01260311
Last updated date
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.
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.
Over Active Bladder
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
- Over-active bladder
- Prescribed with Fesoterodine
Exclusion Criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details
- Hypersensitivity
- Urinary retention
NEED INFO?
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Over Active BladderPost Marketing Surveillance Of Fesoterodine In Filipino Patients With Over Active Bladder
NCT01260311
- Tondo, Manila
- Diliman, Quezon City, Metro Manila
- Pasig City, Metro Manila
- Quezon City, Metro Manila
- Baguio City,
- Batangas,
- Cebu,
- Davao City,
- Davao City,
- Davao City,
- Davao,
- Davao,
- Ilocos Norte,
- La Union,
- Laguna,
- Lucena City,
- Makati City,
- Makati City,
- Makati City,
- Mandaluyong,
- Manila,
- Manila,
- Manila,
- Manila,
- Manila,
- Muntinlupa City,
- Nueva Ecija,
- Philippines,
- Quezon City,
- Quezon City,
- Quezon,
- Quezon,
- South Luzon,
- Tarlac City,
- Valenzuela,
- West Fairview, Quezon City,
- Zamboanga City,
ALL GENDERS
18 Years+
years
MULTIPLE SITES
Advanced Information
| 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 | |||