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Completed

NCT Number: NCT01919047

Drug Use-Results Survey of Betanis Tablets in Japan

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.

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Key information

Conditions

Overactive Bladder Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Lower Urinary Tract Symptoms Male Urogenital Diseases Pathological Conditions, Signs and Symptoms Signs and Symptoms Urinary Bladder Diseases Urinary Bladder, Overactive Urogenital Diseases Urologic Diseases Urological Manifestations

Sex eligibility

All sexes

Study type

Observational

Primary location

Chugoku, Japan

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About this study

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):

  • The occurrence of adverse drug reactions in clinical settings.
  • 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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Betanis

Drug

Oral

Other names: Mirabegron, YM178

Primary outcomes

  1. Occurrence of adverse events and adverse drug reactions

    Time frame: For 12 weeks

Secondary outcomes

  1. Changes in OABSS (overactive bladder symptom score)

    Time frame: baseline and at 12 weeks (or last observation period)

  2. Items of particular interest

    Time frame: baseline and at 12 weeks (or last observation period)

Sponsors and collaborators

Lead sponsor

Astellas Pharma Inc

Industry

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2014
Study completion
2014
First posted
Aug 8, 2013
Registry last updated
Oct 5, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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