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Long-Term Specified Drug Use-results Survey of Betanis Tablets

NCT ID: NCT01901120

Last Updated: 2016-11-01

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

1263 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-10-31

Study Completion Date

2016-09-30

Brief Summary

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This study is to evaluate the safety and efficacy of long-term use of Betanis (generic name: mirabegron), and to determine the adherence to treatment with mirabegron.

Detailed Description

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Conditions

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Overactive Bladder

Keywords

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Betanis® mirabegron Overactive Bladder

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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Betanis

the usual adult dosage of mirabegron once daily after a meal

Betanis

Intervention Type DRUG

oral

Interventions

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Betanis

oral

Intervention Type DRUG

Other Intervention Names

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YM178 mirabegron

Eligibility Criteria

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Inclusion Criteria

* Patients who administer mirabegron for treatment of urinary urgency, daytime frequency, and urgency incontinence associated with overactive bladder and also who have no treatment history of mirabegron.
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_DIRECTOR

Astellas Pharma Inc

Locations

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Chūbu, Chubu, Japan

Site Status

Chugoku, Chugoku, Japan

Site Status

Hokkaido, Hokkaido, Japan

Site Status

Kansai, Kansai, Japan

Site Status

Kanto, Kanto, Japan

Site Status

Kyushu, Kyushu, Japan

Site Status

Shikoku, Shikoku, Japan

Site Status

Tōhoku, Tohoku, Japan

Site Status

Countries

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Japan

Other Identifiers

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BE0002

Identifier Type: -

Identifier Source: org_study_id