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A 12-Week, Randomized, Double-Blind, Placebo Controlled, Parallel Group, Multicenter Trial In Overactive Bladder Subjects To Confirm The Efficacy Of 8 Mg Fesoterodine Compared To 4 Mg Fesoterodine.

Phase 4
18 Years
Open (Enrolling)
Overactive Bladder

Thank you

Trial Information

A 12-Week, Randomized, Double-Blind, Placebo Controlled, Parallel Group, Multicenter Trial In Overactive Bladder Subjects To Confirm The Efficacy Of 8 Mg Fesoterodine Compared To 4 Mg Fesoterodine.

Inclusion Criteria:

- 6 months overactive bladder symptoms, minimum of 2 urgency urinary incontinence
episodes per 24 hours and minimum of 8 micturitions per 24 hours.

Exclusion Criteria:

- Other concurrent and concomitant medication or disease that could put the subjects at
additional risk or interfere with the study results.

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Outcome Measure:

Change in mean number of urgency urinary incontinence episodes per 24 hours at week 12 relative to baseline

Outcome Time Frame:

Baseline, Week 12

Safety Issue:


Principal Investigator

Pfizer Call Center

Investigator Role:

Study Director

Investigator Affiliation:



United States: Food and Drug Administration

Study ID:




Start Date:

May 2011

Completion Date:

January 2013

Related Keywords:

  • Overactive Bladder
  • Urinary Bladder, Overactive



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