Status:
COMPLETED
Long Term Study To Evaluate the Safety, Tolerability and Efficacy of Fesoterodine for Overactive Bladder.
Lead Sponsor:
Pfizer
Conditions:
Overactive Bladder
Eligibility:
All Genders
20+ years
Phase:
PHASE3
Brief Summary
To assess the long term safety, tolerability and efficacy of fesoterodine in patients with OAB.
Eligibility Criteria
Inclusion
- Adult OAB patients who present with OAB symptoms, including micturitions \>= 8 per day and urinary urgency episodes \>=1 per day.
Exclusion
- Patient has known hypersensitivity to the active substance (fesoterodine fumarate) or to peanut or soya or any of the excipients.
- Patient has a known neurological disease influencing bladder function.
- Patient has a complication of lower urinary tract pathology potentially responsible for urgency or incontinence, clinically relevant bladder outlet obstruction or pelvic organ prolapse.
Key Trial Info
Start Date :
February 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2009
Estimated Enrollment :
153 Patients enrolled
Trial Details
Trial ID
NCT00658684
Start Date
February 1 2008
End Date
August 1 2009
Last Update
October 13 2010
Active Locations (12)
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1
Pfizer Investigational Site
Inegeku, Chibashi, Chiba, Japan
2
Pfizer Investigational Site
Akashi-shi, Hyōgo, Japan
3
Pfizer Investigational Site
Amagasaki-shi, Hyōgo, Japan
4
Pfizer Investigational Site
Chuou-ku, Koube-shi, Hyōgo, Japan