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Post Marketing Surveillance Of Fesoterodine In Filipino Patients With Over Active Bladder

Last updated on October 13, 2019

FOR MORE INFORMATION
Study Location
Mary Johnston Hospital, Inc.
Tondo, Manila, 1000 Philippines
Contact
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
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

NCT01260311
Pfizer
Completed
Post Marketing Surveillance Of Fesoterodine In Filipino Patients With Over Active Bladder

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Descriptive Information
Brief TitlePost Marketing Surveillance Of Fesoterodine In Filipino Patients With Over Active Bladder
Official TitlePost Marketing Surveillance To Assess The Safety And Efficacy Of Fesoterodine (Toviaz) On Filipino Patients Diagnosed With Over-Active Bladder
Brief SummaryThis 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 DescriptionSampling method is not applicable in this study. Only patients prescribed Fesoterodine will be enrolled.
Study TypeObservational
Study DesignObservational Model: Cohort
Time Perspective: Prospective
Target Follow-Up DurationNot Provided
BiospecimenNot Provided
Sampling MethodNon-Probability Sample
Study PopulationPatients diagnosed with Over-active bladder
ConditionOver Active Bladder
InterventionDrug: Fesoterodine
Any dose of Fesoterodine
Other Name: Toviaz
Study Groups/CohortsPatients 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 StatusCompleted
Actual Enrollment
 (submitted: November 11, 2013)
508
Original Estimated Enrollment
 (submitted: December 13, 2010)
3000
Actual Study Completion DateOctober 2013
Actual Primary Completion DateOctober 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • Over-active bladder
  • Prescribed with Fesoterodine

Exclusion Criteria:

  • Hypersensitivity
  • Urinary retention
Sex/Gender
Sexes Eligible for Study:All
Ages18 Years and older   (Adult, Older Adult)
Accepts Healthy VolunteersNo
ContactsContact information is only displayed when the study is recruiting subjects
Listed Location CountriesPhilippines
Removed Location Countries  
 
Administrative Information
NCT NumberNCT01260311
Other Study ID NumbersA0221085
Has Data Monitoring CommitteeNo
U.S. FDA-regulated ProductNot Provided
IPD Sharing StatementNot Provided
Responsible PartyPfizer
Study SponsorPfizer
CollaboratorsNot Provided
Investigators
Study Director:Pfizer CT.gov Call CenterPfizer
PRS AccountPfizer
Verification DateSeptember 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

BY EMAIL

Contact

[email protected]

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