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

This study has been completed.
Sponsor:
Information provided by:
Astellas Pharma Inc
ClinicalTrials.gov Identifier:
NCT00840645
First received: February 8, 2009
Last updated: June 8, 2010
Last verified: June 2010
History of Changes
  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: An Open-label, Long-term Study to Assess the Safety and Efficacy of YM178 in Symptomatic Overactive Bladder Patients

Resource links provided by NLM:

Drug Information available for: Mirabegron
U.S. FDA Resources

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
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

No publications provided

Responsible Party: Director, 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: June 8, 2010
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
Urological Manifestations
Signs and Symptoms

ClinicalTrials.gov processed this record on May 19, 2013