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

Primary Purpose

Urinary Bladder, Overactive

Status
Completed
Phase
Phase 3
Locations
Japan
Study Type
Interventional
Intervention
YM178
Sponsored by
Astellas Pharma Inc
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Urinary Bladder, Overactive focused on measuring YM178, Urinary Bladder, Overactive, Mirabegron

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

1. YM178

Arm Description

Outcomes

Primary Outcome Measures

Vital signs, AEs, lab tests, ECG, post-void residual volume

Secondary Outcome Measures

Changes from baseline in the mean number of micturitions/24hrs
Changes from baseline in the mean number of urinary urgencies/24 hrs
Changes from baseline in the mean number of incontinence episodes/24 hrs
Changes from baseline in the mean number of urge incontinence episodes/24 hrs
Changes from baseline in the mean number of nocturnal urinations

Full Information

First Posted
February 8, 2009
Last Updated
January 4, 2016
Sponsor
Astellas Pharma Inc
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1. Study Identification

Unique Protocol Identification Number
NCT00840645
Brief Title
A Long-term Study of YM178 in Symptomatic Overactive Bladder Patients
Official Title
Long-term Study of YM178: Long Term Study of YM178 in Subjects With Overactive Bladder
Study Type
Interventional

2. Study Status

Record Verification Date
January 2016
Overall Recruitment Status
Completed
Study Start Date
December 2008 (undefined)
Primary Completion Date
March 2010 (Actual)
Study Completion Date
March 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Astellas Pharma Inc

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Urinary Bladder, Overactive
Keywords
YM178, Urinary Bladder, Overactive, Mirabegron

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
204 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1. YM178
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
YM178
Other Intervention Name(s)
Mirabegron
Intervention Description
Oral
Primary Outcome Measure Information:
Title
Vital signs, AEs, lab tests, ECG, post-void residual volume
Time Frame
52 weeks
Secondary Outcome Measure Information:
Title
Changes from baseline in the mean number of micturitions/24hrs
Time Frame
52 weeks
Title
Changes from baseline in the mean number of urinary urgencies/24 hrs
Time Frame
52 weeks
Title
Changes from baseline in the mean number of incontinence episodes/24 hrs
Time Frame
52 weeks
Title
Changes from baseline in the mean number of urge incontinence episodes/24 hrs
Time Frame
52 weeks
Title
Changes from baseline in the mean number of nocturnal urinations
Time Frame
52 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility 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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Use Central Contact
Organizational Affiliation
Astellas Pharma Inc
Official's Role
Study Chair
Facility Information:
City
Kansai
Country
Japan
City
Kantou
Country
Japan

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Links:
URL
http://www.clinicaltrials.jp/user/ctrDetail_e.jsp?resultId=698
Description
Link to Results on JAPIC
URL
https://www.astellasclinicalstudyresults.com/hcp/study.aspx?ID=178-CL-051
Description
Link to results on Astellas Clinical Study Results Web site

Learn more about this trial

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

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