A Long-term Study of YM178 in Symptomatic Overactive Bladder Patients

• Status: Completed
• Trial end date: 2010-03-01
• Target enrollment: 0
• Participant gender: All

Summary

The study is intended to test the safety, tolerability, and efficacy of long-term treatment with YM178 in patients with overactive bladder symptoms.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Astellas Pharma Inc
• Treatments: Mirabegron

Criteria

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)