NCT01919047

Drug Use-Results Survey of Betanis Tablets in Japan

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 10,711 (actual)
• Sponsor: Astellas Pharma Inc · Industry
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

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

Conditions

• Overactive Bladder

Interventions

Type	Name	Description
DRUG	Betanis	Oral

Timeline

• Start date: 2012-04-01
• Primary completion: 2014-07-01
• Completion: 2014-07-01
• First posted: 2013-08-08
• Last updated: 2015-10-05

Locations

8 sites across 1 country: Japan