Status:
COMPLETED
Effect and Safety Of Detrol LA In Men With Overactive Bladder Symptoms With Or Without Bladder Outlet Obstruction
Lead Sponsor:
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Conditions:
Urinary Incontinence
Eligibility:
MALE
40+ years
Phase:
PHASE4
Brief Summary
The primary objective of the trial is to evaluate the effect of tolterodine ER plus tamsulosin versus placebo on patient perception of overall treatment benefit in men who have frequency and urgency, ...
Eligibility Criteria
Inclusion
- Male 40 years of age
- Clinical signs and symptoms of frequency and urgency, with or without UUI, with or without BOO, for at least three months
- Mean urinary frequency of 8 micturitions/24h verified by the Screening micturition diary
Exclusion
- Post-void residual urine volume (PVR) of \> 200 ml as measured by an ultrasound
- Maximum urinary flow rate (Qmax) of \< 5 ml/second as measured by a flowmeter; a voided volume of 75 ml is required in order to accurately record the Qmax
- Prescribed and administered an antimuscarinic or antispasmodic within 1 month
- Prescribed and administered an a-1-adrenergic antagonist within 2 weeks
Key Trial Info
Start Date :
November 1 2004
Trial Type :
INTERVENTIONAL
End Date :
May 1 2006
Estimated Enrollment :
830 Patients enrolled
Trial Details
Trial ID
NCT00147654
Start Date
November 1 2004
End Date
May 1 2006
Last Update
January 27 2021
Active Locations (95)
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1
Pfizer Investigational Site
Birmingham, Alabama, United States
2
Pfizer Investigational Site
Homewood, Alabama, United States
3
Pfizer Investigational Site
Tucson, Arizona, United States
4
Pfizer Investigational Site
Anaheim, California, United States