A Study Of Efficacy And Safety Of Fesoterodine In Vulnerable Elderly Subjects With Overactive Bladder

Completed · Phase 4 · Has a placebo group

Conditions studied: Overactive Bladder

In brief

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 bladder (OAB).

Key facts

Study ID

NCT00928070

Run by

Pfizer

People needed

566

Starts

2009-09-01

Expected to finish

2011-09-01

Last updated by the study team

2013-01-17

Who can join

Age: 65 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Pfizer Investigational Site — Birmingham, Alabama, United States
• Pfizer Investigational Site — Montgomery, Alabama, United States
• Pfizer Investigational Site — Green Valley, Arizona, United States
• Pfizer Investigational Site — Mesa, Arizona, United States
• Pfizer Investigational Site — Phoenix, Arizona, United States
• Pfizer Investigational Site — Tucson, Arizona, United States
• Pfizer Investigational Site — Tuscon, Arizona, United States
• Pfizer Investigational Site — Little Rock, Arkansas, United States
• Pfizer Investigational Site — Little Rock, Arkansas, United States
• Pfizer Investigational Site — Costa Mesa, California, United States
• Pfizer Investigational Site — Fairfield, California, United States
• Pfizer Investigational Site — Glendora, California, United States
• Pfizer Investigational Site — La Mesa, California, United States
• Pfizer Investigational Site — Long Beach, California, United States
• Pfizer Investigational Site — Mission Viejo, California, United States
• Pfizer Investigational Site — Murrieta, California, United States
• Pfizer Investigational Site — Norwalk, California, United States
• Pfizer Investigational Site — Paramount, California, United States
• Pfizer Investigational Site — Rancho Santa Margarita, California, United States
• Pfizer Investigational Site — San Bernardino, California, United States
• Pfizer Investigational Site — San Diego, California, United States
• Pfizer Investigational Site — Santa Ana, California, United States
• Pfizer Investigational Site — Temecula, California, United States
• Pfizer Investigational Site — Vacaville, California, United States
• Pfizer Investigational Site — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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