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

Astellas

Status and phase: Completed; Phase 3

Conditions: Urinary Bladder, Overactive

Treatments: Drug: YM178

Study type: Interventional

Funder types: Industry

Identifiers

NCT00840645

178-CL-051

Details and patient eligibility

About

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

Enrollment: 204 patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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204 participants in 1 patient group

1. YM178

Experimental group

Treatment:

Drug: YM178