Drug Use-Results Survey of Betanis Tablets in Japan

NCT ID: NCT01919047

Last Updated: 2015-10-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

10711 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-04-30

Study Completion Date

2014-07-31

Brief Summary

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This study is to determine the following information.

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

Detailed Description

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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):

1. The occurrence of adverse drug reactions in clinical settings.
2. 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

Conditions

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Overactive Bladder

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Betanis group

Patients receiving Betanis for Overactive Bladder

Betanis

Intervention Type DRUG

Oral

Interventions

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Betanis

Oral

Intervention Type DRUG

Other Intervention Names

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Mirabegron YM178

Eligibility Criteria

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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.
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Astellas Pharma Inc

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Central Contact

Role: STUDY_CHAIR

Astellas Pharma Inc

Locations

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Chugoku, , Japan

Site Status

Chūbu, , Japan

Site Status

Hokkaido, , Japan

Site Status

Kansai, , Japan

Site Status

Kantou, , Japan

Site Status

Kyushu, , Japan

Site Status

Shikoku, , Japan

Site Status

Tōhoku, , Japan

Site Status

Countries

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Japan

Other Identifiers

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BE0001

Identifier Type: -

Identifier Source: org_study_id

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