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Drug Use-Results Survey of Betanis Tablets in Japan

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Astellas

Status

Completed

Conditions

Overactive Bladder

Treatments

Drug: Betanis

Study type

Observational

Funder types

Industry

Identifiers

Details and patient eligibility

About

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.

Full 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

Enrollment

10,711 patients

Sex

All

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial design

10,711 participants in 1 patient group

Betanis group
Description:
Patients receiving Betanis for Overactive Bladder
Treatment:
Drug: Betanis

Trial contacts and locations

8

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Data sourced from clinicaltrials.gov

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