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OpenTrials
Completed

NCT Number: NCT02570035

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

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.

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Key information

Conditions

Overactive Bladder Cardiovascular Disease Cardiovascular Diseases 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

Site JP81013, Aichi, Japan

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Who can participate

Healthy volunteers accepted: No

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

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)

Treatment and study plan

Mirabegron

Drug

oral

Other names: YM178, Betanis

Primary outcomes

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

    Time frame: Baseline and up to four weeks

  2. Incidence rate of cardiovascular system adverse reactions

    Time frame: Up to four weeks

  3. Safety assessed by biochemistry laboratory tests

    Time frame: Up to four weeks

  4. Safety assessed by incidence of adverse events

    Time frame: Up to four weeks

Secondary outcomes

  1. Changes in overactive bladder (OAB) symptoms

    Time frame: Baseline and up to four weeks

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

Sponsors and collaborators

Lead sponsor

Astellas Pharma Inc

Industry

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2015
Study completion
2015
First posted
Oct 7, 2015
Registry last updated
Oct 7, 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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