Drug Use-Results Survey of Betanis Tablets in Japan

Overactive Bladder Clinical Trial

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

Status Completed

Clinical Trial 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.

Clinical Trial 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 ;

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Overactive Bladder
• Urinary Bladder, Overactive

• NCT number: NCT01919047
• Study type: Observational
• Source: Astellas Pharma Inc
• Status: Completed
• Phase: N/A
• Start date: April 2012
• Completion date: July 2014