A Long-term Study of YM178 in Symptomatic Overactive Bladder Patients
- Registration Number
- NCT00840645
- Lead Sponsor
- Astellas Pharma Inc
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 204
Inclusion Criteria
- 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 Criteria
- 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)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description 1. YM178 YM178 -
- Primary Outcome Measures
Name Time Method Vital signs, AEs, lab tests, ECG, post-void residual volume 52 weeks
- Secondary Outcome Measures
Name Time Method Changes from baseline in the mean number of urinary urgencies/24 hrs 52 weeks Changes from baseline in the mean number of incontinence episodes/24 hrs 52 weeks Changes from baseline in the mean number of urge incontinence episodes/24 hrs 52 weeks Changes from baseline in the mean number of nocturnal urinations 52 weeks Changes from baseline in the mean number of micturitions/24hrs 52 weeks