Urinary Bladder, Overactive
Conditions
Keywords
YM178, Urinary Bladder, Overactive, Mirabegron
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.
Interventions
DRUGYM178
Oral
Sponsors
Astellas Pharma Inc
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Vital signs, AEs, lab tests, ECG, post-void residual volume | 52 weeks |
Secondary
| Measure | Time frame |
|---|---|
| Changes from baseline in the mean number of micturitions/24hrs | 52 weeks |
| 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 |
Countries
Japan
Outcome results
None listed