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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

204 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-12-31

Study Completion Date

2010-03-31

Brief Summary

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

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Detailed Description

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Conditions

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Urinary Bladder, Overactive

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1. YM178

Group Type EXPERIMENTAL

YM178

Intervention Type DRUG

Oral

Interventions

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YM178

Oral

Intervention Type DRUG

Other Intervention Names

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Mirabegron

Eligibility Criteria

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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)

Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No