Drug Use-Results Survey of Betanis Tablets in Japan

Drug Use-Results Survey of Betanis Tablets 25 and 50 mg

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01919047

Enrollment

10711

Registered

2013-08-08

Start date

2012-04-30

Completion date

2014-07-31

Last updated

2015-10-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Overactive Bladder

Keywords

overactive bladder, mirabegron, occurrence of adverse events, Overactive Bladder Symptom Score

Brief summary

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

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

Interventions

DRUGBetanis

Oral

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Healthy volunteers

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.

Design outcomes

Primary

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

Secondary

Measure	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)

Countries

Japan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026