A Study of YM178 in Subjects With Symptoms of Overactive Bladder

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01043666
Recruitment Status : Completed
First Posted : January 7, 2010
Last Update Posted : February 16, 2017
Information provided by (Responsible Party):
Astellas Pharma Inc

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

Condition or disease Intervention/treatment Phase
Urinary Bladder, Overactive Drug: YM178 Drug: Placebo Drug: tolterodine ER Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1126 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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
Study Start Date : December 2009
Actual Primary Completion Date : September 2011
Actual Study Completion Date : September 2011

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: YM178 group
Drug: YM178
Other Name: mirabegron

Placebo Comparator: placebo group
Drug: Placebo

Experimental: tolterodine ER group
Drug: tolterodine ER
Other Name: Detrusitol SR

Primary Outcome Measures :
  1. Change in mean number of micturitions per 24 hrs [ Time Frame: Within a 12-week treatment period ]

Secondary Outcome Measures :
  1. Change in mean number of urgency episodes per 24 hrs [ Time Frame: Within a 12-week treatment period ]
  2. Change in mean number of urinary incontinence episodes per 24 hrs [ Time Frame: Within a 12-week treatment period ]
  3. Change in mean number of urge incontinence episodes per 24 hrs [ Time Frame: Within a 12-week treatment period ]
  4. Change in mean volume voided per micturition [ Time Frame: Within a 12-week treatment period ]
  5. Change in mean number of nocturia episodes [ Time Frame: Within a 12-week treatment period ]
  6. Safety assessed by vital signs, adverse events laboratory findings, 12-lead electrocardiogram and post-void residual volume [ Time Frame: During 12-week treatment ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01043666

Beijing, China
Dalian, China
Fuzhou, China
Guangzhou, China
Hangzhou, China
Hubei, China
Hunan, China
Jiangsu, China
Liaoning, China
Nanjing, China
Shanghai, China
Ahmedabad, India
Gurgaon, India
Jaipur, India
Lucknow, India
New Delhi, India
Pune, India
Korea, Republic of
Busan, Korea, Republic of
Chungcheong Namdo, Korea, Republic of
Daegu, Korea, Republic of
Daejeon, Korea, Republic of
Gwangju, Korea, Republic of
Gyeonggi, Korea, Republic of
Incheon, Korea, Republic of
Jeollabuk, Korea, Republic of
Jeollanam, Korea, Republic of
Kyonggi, Korea, Republic of
Seoul, Korea, Republic of
Chia-Yi, Taiwan
Hualien, Taiwan
Kaohsiung, Taiwan
Taichung, Taiwan
Tainan, Taiwan
Taipei, Taiwan
Taoyuan, Taiwan
Sponsors and Collaborators
Astellas Pharma Inc
Study Chair: Use Central Contact Astellas Pharma Inc

Additional Information:
Responsible Party: Astellas Pharma Inc Identifier: NCT01043666     History of Changes
Other Study ID Numbers: 178-CL-090
First Posted: January 7, 2010    Key Record Dates
Last Update Posted: February 16, 2017
Last Verified: February 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Details of the IPD sharing plan for this study can be found at

Keywords provided by Astellas Pharma Inc:
Urinary incontinence
Overactive Bladder
Urinary urge incontinence

Additional relevant MeSH terms:
Urinary Bladder, Overactive
Urinary Bladder Diseases
Urologic Diseases
Lower Urinary Tract Symptoms
Urological Manifestations
Signs and Symptoms
Tolterodine Tartrate
Muscarinic Antagonists
Cholinergic Antagonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Urological Agents
Adrenergic beta-3 Receptor Agonists
Adrenergic beta-Agonists
Adrenergic Agonists
Adrenergic Agents