A Study of YM178 in Subjects With Symptoms of Overactive Bladder

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Astellas Pharma Inc
ClinicalTrials.gov Identifier:
NCT01043666
First received: January 5, 2010
Last updated: September 16, 2013
Last verified: October 2011
  Purpose

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


Condition Intervention Phase
Urinary Bladder, Overactive
Drug: YM178
Drug: Placebo
Drug: tolterodine ER
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:


Further study details as provided by Astellas Pharma Inc:

Primary Outcome Measures:
  • Change in mean number of micturitions per 24 hrs [ Time Frame: Within a 12-week treatment period ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change in mean number of urgency episodes per 24 hrs [ Time Frame: Within a 12-week treatment period ] [ Designated as safety issue: No ]
  • Change in mean number of urinary incontinence episodes per 24 hrs [ Time Frame: Within a 12-week treatment period ] [ Designated as safety issue: No ]
  • Change in mean number of urge incontinence episodes per 24 hrs [ Time Frame: Within a 12-week treatment period ] [ Designated as safety issue: No ]
  • Change in mean volume voided per micturition [ Time Frame: Within a 12-week treatment period ] [ Designated as safety issue: No ]
  • Change in mean number of nocturia episodes [ Time Frame: Within a 12-week treatment period ] [ Designated as safety issue: No ]
  • Safety assessed by vital signs, adverse events laboratory findings, 12-lead electrocardiogram and post-void residual volume [ Time Frame: During 12-week treatment ] [ Designated as safety issue: No ]

Enrollment: 1126
Study Start Date: December 2009
Study Completion Date: September 2011
Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: YM178 group Drug: YM178
oral
Other Name: mirabegron
Placebo Comparator: placebo group Drug: Placebo
oral
Experimental: tolterodine ER group Drug: tolterodine ER
oral
Other Name: Detrusitol SR

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01043666

Locations
China
Beijing, China
Dalian, China
Fuzhou, China
Guangzhou, China
Hangzhou, China
Hubei, China
Hunan, China
Jiangsu, China
Liaoning, China
Nanjing, China
Shanghai, China
India
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
Taiwan
Chia-Yi, Taiwan
Hualien, Taiwan
Kaohsiung, Taiwan
Taichung, Taiwan
Tainan, Taiwan
Taipei, Taiwan
Taoyuan, Taiwan
Sponsors and Collaborators
Astellas Pharma Inc
Investigators
Study Chair: Use Central Contact Astellas Pharma Inc
  More Information

Additional Information:
No publications provided

Responsible Party: Astellas Pharma Inc
ClinicalTrials.gov Identifier: NCT01043666     History of Changes
Other Study ID Numbers: 178-CL-090
Study First Received: January 5, 2010
Last Updated: September 16, 2013
Health Authority: China: Food and Drug Administration
Korea: Food and Drug Administration
Taiwan: Department of Health
India: Drugs Controller General of India

Keywords provided by Astellas Pharma Inc:
Overactive Bladder
Frequency
Micturition
Urgency
Urinary incontinence
Urinary urge incontinence
YM178

Additional relevant MeSH terms:
Urinary Bladder, Overactive
Urinary Bladder Diseases
Urologic Diseases
Urological Manifestations
Signs and Symptoms
Tolterodine
Muscarinic Antagonists
Cholinergic Antagonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on July 22, 2014