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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Astellas Pharma Inc
ClinicalTrials.gov Identifier:
NCT00840645
First received: February 8, 2009
Last updated: July 15, 2013
Last verified: July 2013
  Purpose

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


Condition Intervention Phase
Urinary Bladder, Overactive
Drug: YM178
Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Long-term Study of YM178: Long Term Study of YM178 in Subjects With Overactive Bladder

Resource links provided by NLM:


Further study details as provided by Astellas Pharma Inc:

Primary Outcome Measures:
  • Vital signs, AEs, lab tests, ECG, post-void residual volume [ Time Frame: 52 weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Changes from baseline in the mean number of micturitions/24hrs [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
  • Changes from baseline in the mean number of urinary urgencies/24 hrs [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
  • Changes from baseline in the mean number of incontinence episodes/24 hrs [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
  • Changes from baseline in the mean number of urge incontinence episodes/24 hrs [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
  • Changes from baseline in the mean number of nocturnal urinations [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]

Enrollment: 204
Study Start Date: December 2008
Study Completion Date: March 2010
Primary Completion Date: March 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1. YM178 Drug: YM178
Oral
Other Name: Mirabegron

  Eligibility

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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)
  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: NCT00840645

Locations
Japan
Kansai, Japan
Kantou, Japan
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: NCT00840645     History of Changes
Other Study ID Numbers: 178-CL-051
Study First Received: February 8, 2009
Last Updated: July 15, 2013
Health Authority: Japan: Pharmaceuticals and Medical Devices Agency

Keywords provided by Astellas Pharma Inc:
YM178
Urinary Bladder, Overactive
Mirabegron

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

ClinicalTrials.gov processed this record on August 21, 2014