Study Results
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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COMPLETED
10711 participants
OBSERVATIONAL
2012-04-30
2014-07-31
Brief Summary
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1. The occurrence of adverse drug reactions in clinical settings.
2. Factors potentially impacting safety, effectiveness, and other aspects.
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Detailed Description
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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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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Betanis group
Patients receiving Betanis for Overactive Bladder
Betanis
Oral
Interventions
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Betanis
Oral
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
ALL
No
Sponsors
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Astellas Pharma Inc
INDUSTRY
Responsible Party
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Principal Investigators
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Central Contact
Role: STUDY_CHAIR
Astellas Pharma Inc
Locations
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Chugoku, , Japan
Chūbu, , Japan
Hokkaido, , Japan
Kansai, , Japan
Kantou, , Japan
Kyushu, , Japan
Shikoku, , Japan
Tōhoku, , Japan
Countries
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Other Identifiers
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BE0001
Identifier Type: -
Identifier Source: org_study_id
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