A Long-term Study of YM178 in Symptomatic Overactive Blad... | NCT00840645

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

NCT00840645

Sponsor

Astellas Pharma Inc

Status

Completed

Last Update Posted

Jan 5, 2016Estimated

Enrollment

204Actual

Phase

Phase 3

Conditions

Urinary Bladder, Overactive

Interventions

YM178

Countries

Japan

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2016

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 2008

Primary Completion Date

Mar 2010Actual

Completion Date

Mar 2010Actual

First Submitted Date

Feb 8, 2009

First Submission Date that Met QC Criteria

Feb 8, 2009

First Posted Date

Feb 10, 2009Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 4, 2016

Last Update Posted Date

Jan 5, 2016Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

204Actual

Label	Type	Description	Intervention Names
1. YM178	Experimental		Drug: YM178

Name	Type	Description	Arm Group Labels	Other Names
YM178	Drug	Oral	1. YM178	Mirabegron

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Vital signs, AEs, lab tests, ECG, post-void residual volume		52 weeks

Secondary Outcomes

Measure	Description	Time Frame
Changes from baseline in the mean number of micturitions/24hrs		52 weeks
Changes from baseline in the mean number of urinary urgencies/24 hrs		52 weeks
Changes from baseline in the mean number of incontinence episodes/24 hrs

Other Outcomes

Not provided

Eligibility Module

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)

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Name	Affiliation	Role
Use Central Contact	Astellas Pharma Inc	Study Chair

Label	URL
Link to results on Astellas Clinical Study Results Web site	View source

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D053201	Urinary Bladder, Overactive

Ancestor Terms

ID	Term
D001745	Urinary Bladder Diseases
D014570	Urologic Diseases
D052776	Female Urogenital Diseases
D005261	Female Urogenital Diseases and Pregnancy Complications

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
C520025	mirabegron

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided

Facility	Status	City	State	ZIP	Country	Contacts
		Kansai			Japan