A Study of YM178 in Subjects With Symptoms of Overactive Bladder

Study Overview
=================
Brief Summary
-----------------
This study is to assess the efficacy and safety of YM178 in patients with symptoms of overactive bladder.

Official Title
-----------------
Phase III Study of YM178: A Randomized, Double-blind, Parallel Group, Placebo and Active Controlled, Multi-center Study in Subjects With Symptoms of Overactive Bladder

Conditions
-----------------
Urinary Bladder, Overactive

Intervention / Treatment
-----------------
* Drug: YM178
* Drug: Placebo
* Drug: tolterodine ER


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subjects with symptoms of overactive bladder for at least 12 weeks before the study Subjects capable of walking to the lavatory without assistance and measuring the urine volume by him/herself Subject with an average frequency of micturition of 8 or more times per 24-hour period Subject with an average episode of urgency or urge incontinence of one or more times per 24-hours period Subject having provided written informed consent by him/herself Exclusion Criteria: Subject having stress urinary incontinence as a predominant symptom Subject with transient symptoms suspected for overactive bladder Subject complicated with urinary tract infection, urinary stones, and/or interstitial cystitis or with a historical condition of recurrent urinary tract infection Subject complicated with bladder tumor/prostatic tumor or with the historical condition Subject confirmed to have a post-void residual volume of >=100ml or with a clinically significant lower urinary tract obstructive disease Subject with indwelling catheter or practicing intermittent self-catheterization Subject giving radiotherapy influencing urinary tract functions, or thermotherapy for benign prostatic hyperplasia Subject giving surgical therapy which may influence urinary tract functions within 24 weeks before the study Subject with uncontrolled hypertension (indicated by sitting SBP >=180mmHg or DPB >= 110mmHg) Subject with a pulse rate >= 110bpm or <50 bpm

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: YM178 group<br>oral | Drug: YM178<br>* oral<br>* Other names: mirabegron;|
| Placebo Comparator: placebo group<br>oral | Drug: Placebo<br>* oral<br>|
| Experimental: tolterodine ER group<br>oral | Drug: tolterodine ER<br>* oral<br>* Other names: Detrusitol SR;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in mean number of micturitions per 24 hrs |  | Within a 12-week treatment period | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in mean number of urgency episodes per 24 hrs |  | Within a 12-week treatment period | 
| Change in mean number of urinary incontinence episodes per 24 hrs |  | Within a 12-week treatment period | 
| Change in mean number of urge incontinence episodes per 24 hrs |  | Within a 12-week treatment period | 
| Change in mean volume voided per micturition |  | Within a 12-week treatment period | 
| Change in mean number of nocturia episodes |  | Within a 12-week treatment period | 
| Safety assessed by vital signs, adverse events laboratory findings, 12-lead electrocardiogram and post-void residual volume |  | During 12-week treatment | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Micturition, YM178, Urinary incontinence, Frequency, Overactive Bladder, Urgency, Urinary urge incontinence