Specified Drug Use-results Survey of Betanis Tablets for Patients With Coexisting Cardiovascular Disease

Astellas Pharma Inc316 enrolled

Overview

This purpose of this study is to investigate the effects of mirabegron on the cardiovascular system in patients with overactive bladder with current or a history of cardiovascular disease.

Study Type

OBSERVATIONAL

Enrollment

316

Conditions

Overactive Bladder Cardiovascular Disease

Interventions

MirabegronDRUG

oral

Eligibility

Sex: ALL

Medical Language ↔ Plain English

Inclusion Criteria: * having coexisting cardiovascular disease or a history of cardiovascular diseases * having electrocardiogram record conducted within seven days before the start of the mirabegron treatment (including the first day of administration) Exclusion Criteria: * having serious cardiovascular disease * having significant long QT (QTc \> 500 msec)

Locations (28)

Site JP81013

Aichi, Japan

Site JP81014

Aichi, Japan

Outcomes

Primary Outcomes

Changes in electrocardiogram parameters pre- and post- administration of mirabegron

Time frame: Baseline and up to four weeks

Incidence rate of cardiovascular system adverse reactions

Time frame: Up to four weeks

Safety assessed by biochemistry laboratory tests

Time frame: Up to four weeks

Safety assessed by incidence of adverse events

Time frame: Up to four weeks

Secondary Outcomes

Changes in overactive bladder (OAB) symptoms

Clinical global impression of change from baseline of OAB symptoms by investigator

Time frame: Baseline and up to four weeks

Data from ClinicalTrials.gov

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