Status:
COMPLETED
A Study Of Efficacy And Safety Of Fesoterodine In Vulnerable Elderly Subjects With Overactive Bladder
Lead Sponsor:
Pfizer
Conditions:
Overactive Bladder
Eligibility:
All Genders
65+ years
Phase:
PHASE4
Brief Summary
This study is designed to assess the efficacy and safety of a flexible dose regimen of fesoterodine on urgency urinary incontinence (UUI) episodes in vulnerable elderly subjects with overactive bladde...
Eligibility Criteria
Inclusion
- male or female subjects 65 years of age or older
- OAB symptoms for at least 3 months
- score 3 or greater on Vulnerable Elderly Survey (VES-13)
- adequate mobility for independent toileting
- mean number of at least 2 UUI episodes per 24 hours
- mean urinary frequency of 8 or more micturitions per 24 hours
- able to independently complete the bladder diaries
Exclusion
- PVR urinary volume greater than 200 ml
- MMSE score less than 20
- greater than 15 UUI episodes per 24 hours
- creatinine clearance less than 30 ml/min
- an average resting heart rate of greater than or equal to 90 beats per minute
Key Trial Info
Start Date :
September 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2011
Estimated Enrollment :
566 Patients enrolled
Trial Details
Trial ID
NCT00928070
Start Date
September 1 2009
End Date
September 1 2011
Last Update
January 17 2013
Active Locations (125)
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1
Pfizer Investigational Site
Birmingham, Alabama, United States, 35233
2
Pfizer Investigational Site
Birmingham, Alabama, United States, 35294
3
Pfizer Investigational Site
Montgomery, Alabama, United States, 36117
4
Pfizer Investigational Site
Green Valley, Arizona, United States, 85614