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

October 6, 2015 updated by: Astellas Pharma Inc

Protocol for 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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

316

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Japan
      • Aichi, Japan
        • Site JP81013
      • Aichi, Japan
        • Site JP81014
      • Chiba, Japan
        • Site JP81005
      • Chiba, Japan
        • Site JP81006
      • Chiba, Japan
        • Site JP81007
      • Fukuoka, Japan
        • Site JP81026
      • Fukuoka, Japan
        • Site JP81027
      • Hokkaido, Japan
        • Site JP81001
      • Hokkaido, Japan
        • Site JP81002
      • Hyogo, Japan
        • Site JP81021
      • Hyogo, Japan
        • Site JP81022
      • Hyogo, Japan
        • Site JP81023
      • Hyogo, Japan
        • Site JP81024
      • Hyogo, Japan
        • Site JP81025
      • Kagoshima, Japan
        • Site JP81028
      • Kanagawa, Japan
        • Site JP81011
      • Kanagawa, Japan
        • Site JP81012
      • Niigata, Japan
        • Site JP81003
      • Osaka, Japan
        • Site JP81019
      • Osaka, Japan
        • Site JP81016
      • Osaka, Japan
        • Site JP81017
      • Osaka, Japan
        • Site JP81018
      • Osaka, Japan
        • Site JP81020
      • Saitama, Japan
        • Site JP81004
      • Shizuoka, Japan
        • Site JP81015
      • Tokyo, Japan
        • Site JP81010
      • Tokyo, Japan
        • Site JP81008
      • Tokyo, Japan
        • Site JP81009

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Overactive bladder patients with current or a history of cardiovascular disease and treated with mirabegron

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Mirabegron group
Subjects with overactive bladder and cardiovascular disease prescribed mirabegron
Drug: Mirabegron
oral
Other Names:
  • YM178
  • Betanis

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Changes in electrocardiogram parameters pre- and post- administration of mirabegron
Time Frame: Baseline and up to four weeks
Baseline and up to four weeks
Incidence rate of cardiovascular system adverse reactions
Time Frame: Up to four weeks
Up to four weeks
Safety assessed by biochemistry laboratory tests
Time Frame: Up to four weeks
Up to four weeks
Safety assessed by incidence of adverse events
Time Frame: Up to four weeks
Up to four weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Baseline and up to four weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Astellas Pharma Inc

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2012

Primary Completion (Actual)

March 1, 2015

Study Completion (Actual)

March 1, 2015

Study Registration Dates

First Submitted

October 6, 2015

First Submitted That Met QC Criteria

October 6, 2015

First Posted (Estimate)

October 7, 2015

Study Record Updates

Last Update Posted (Estimate)

October 7, 2015

Last Update Submitted That Met QC Criteria

October 6, 2015

Last Verified

October 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BE0003

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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