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

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ClinicalTrials.gov Identifier: NCT00840645
Recruitment Status : Completed
First Posted : February 10, 2009
Last Update Posted : January 5, 2016
Sponsor:
Information provided by (Responsible Party):
Astellas Pharma Inc

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

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

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 204 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Long-term Study of YM178: Long Term Study of YM178 in Subjects With Overactive Bladder
Study Start Date : December 2008
Actual Primary Completion Date : March 2010
Actual Study Completion Date : March 2010

Resource links provided by the National Library of Medicine

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

Arm Intervention/treatment
Experimental: 1. YM178 Drug: YM178
Oral
Other Name: Mirabegron



Primary Outcome Measures :
  1. Vital signs, AEs, lab tests, ECG, post-void residual volume [ Time Frame: 52 weeks ]

Secondary Outcome Measures :
  1. Changes from baseline in the mean number of micturitions/24hrs [ Time Frame: 52 weeks ]
  2. Changes from baseline in the mean number of urinary urgencies/24 hrs [ Time Frame: 52 weeks ]
  3. Changes from baseline in the mean number of incontinence episodes/24 hrs [ Time Frame: 52 weeks ]
  4. Changes from baseline in the mean number of urge incontinence episodes/24 hrs [ Time Frame: 52 weeks ]
  5. Changes from baseline in the mean number of nocturnal urinations [ Time Frame: 52 weeks ]


Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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)

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 ClinicalTrials.gov identifier (NCT number): NCT00840645


Locations
Japan
Kansai, Japan
Kantou, Japan
Sponsors and Collaborators
Astellas Pharma Inc
Investigators
Study Chair: Use Central Contact Astellas Pharma Inc

Additional Information:
Responsible Party: Astellas Pharma Inc
ClinicalTrials.gov Identifier: NCT00840645     History of Changes
Other Study ID Numbers: 178-CL-051
First Posted: February 10, 2009    Key Record Dates
Last Update Posted: January 5, 2016
Last Verified: January 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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
Adrenergic beta-3 Receptor Agonists
Adrenergic beta-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Urological Agents