Drug Use-Results Survey of Betanis Tablets in Japan | NCT01919047

Studies
Drug Use-Results Survey of Betanis Tablets in Japan

NCT01919047

Sponsor

Astellas Pharma Inc

Status

Completed

Last Update Posted

Oct 5, 2015Estimated

Enrollment

10,711Actual

Phase

Not provided

Conditions

Overactive Bladder

Interventions

Betanis

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

Oct 2015

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

Apr 2012

Primary Completion Date

Jul 2014Actual

Completion Date

Jul 2014Actual

First Submitted Date

Aug 6, 2013

First Submission Date that Met QC Criteria

Aug 6, 2013

First Posted Date

Aug 8, 2013Estimated

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

Oct 2, 2015

Last Update Posted Date

Oct 5, 2015Estimated

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

This study is to determine the following information.

The occurrence of adverse drug reactions in clinical settings.
Factors potentially impacting safety, effectiveness, and other aspects.

Detailed Description

This survey aims to determine the following information and the need for conducting specified drug use-results surveys and post-marketing clinical studies in patients using Betanis (generic name: mirabegron):

The occurrence of adverse drug reactions in clinical settings.
Factors potentially impacting safety, effectiveness, and other aspects.

Items of Particular Interest:

Safety and effectiveness in patients with hepatic impairment and patients with renal impairment.
Safety and effectiveness when mirabegron is used concomitantly with other drugs (α1 blockers, anticholinergic agents, 5α reductase inhibitors, drugs with a potent CYP3A4-inhibiting effect, drugs with a CYP3A4-inducing effect, drugs metabolized primarily by CYP2D6, and other frequently used drugs).
The occurrence of cardiovascular adverse events.
The occurrence of adverse events related to increased intraocular pressure.
The occurrence of urinary retention

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

10,711Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Betanis group		Patients receiving Betanis for Overactive Bladder	Drug: Betanis

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Betanis	Drug	Oral	Betanis group	Mirabegron YM178

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Occurrence of adverse events and adverse drug reactions		For 12 weeks

Secondary Outcomes

Measure	Description	Time Frame
Changes in OABSS (overactive bladder symptom score)		baseline and at 12 weeks (or last observation period)
Items of particular interest		baseline and at 12 weeks (or last observation period)

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients who received mirabegron for the first time for the treatment of urinary urgency, daytime frequency, and urgency incontinence associated with overactive bladder.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Patients who received mirabegron for the first time for the treatment of urinary urgency, daytime frequency, and urgency incontinence associated with overactive bladder.

Sampling Method

Non-Probability Sample

Name	Affiliation	Role
Central Contact	Astellas Pharma Inc	Study Chair

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
		Chugoku			Japan