Status:
COMPLETED
A Long-term Study of YM178 in Symptomatic Overactive Bladder Patients
Lead Sponsor:
Astellas Pharma Inc
Conditions:
Urinary Bladder, Overactive
Eligibility:
All Genders
20+ years
Phase:
PHASE3
Brief Summary
The study is intended to test the safety, tolerability, and efficacy of long-term treatment with YM178 in patients with overactive bladder symptoms.
Eligibility Criteria
Inclusion
- Subject has symptoms of overactive bladder for \>= 24 wks
- Subject experiences frequency of micturition at average \>= 8 times per 24 hrs confirmed by the 3-day patient diary
Exclusion
- Subject is breastfeeding, pregnant, or intends to become pregnant during the study
- Subject obviously has stress incontinence
- Subject has an indwelling catheter or practices intermittent self catheterization
- Subject has evidence of symptomatic urinary tract infection, interstitial cystitis, bladder stone, etc
- Subject has an average total daily urine volume \> 3000 mL confirmed by patient diary
- Subject has uncontrollable hypertension (SBP \>= 180 mmHg or DBP \>= 110 mmHg)
Key Trial Info
Start Date :
December 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2010
Estimated Enrollment :
204 Patients enrolled
Trial Details
Trial ID
NCT00840645
Start Date
December 1 2008
End Date
March 1 2010
Last Update
January 5 2016
Active Locations (2)
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1
Kansai, Japan
2
Kantou, Japan