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

NCT ID: NCT02570035

Last Updated: 2015-10-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

316 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-12-31

Study Completion Date

2015-03-31

Brief Summary

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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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Detailed Description

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Conditions

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Overactive Bladder Cardiovascular Disease

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Mirabegron group

Subjects with overactive bladder and cardiovascular disease prescribed mirabegron

Mirabegron

Intervention Type DRUG

oral

Interventions

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Mirabegron

oral

Intervention Type DRUG

Other Intervention Names

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YM178 Betanis

Eligibility Criteria

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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)
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Astellas Pharma Inc

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Medical Director

Role: STUDY_DIRECTOR

Astellas Pharma Inc

Locations

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Site JP81013

Aichi, , Japan

Site Status

Site JP81014

Aichi, , Japan

Site Status

Site JP81005

Chiba, , Japan

Site Status

Site JP81006

Chiba, , Japan

Site Status

Site JP81007

Chiba, , Japan

Site Status

Site JP81026

Fukuoka, , Japan

Site Status

Site JP81027

Fukuoka, , Japan

Site Status

Site JP81001

Hokkaido, , Japan

Site Status

Site JP81002

Hokkaido, , Japan

Site Status

Site JP81021

Hyōgo, , Japan

Site Status

Site JP81022

Hyōgo, , Japan

Site Status

Site JP81023

Hyōgo, , Japan

Site Status

Site JP81024

Hyōgo, , Japan

Site Status

Site JP81025

Hyōgo, , Japan

Site Status

Site JP81028

Kagoshima, , Japan

Site Status

Site JP81011

Kanagawa, , Japan

Site Status

Site JP81012

Kanagawa, , Japan

Site Status

Site JP81003

Niigata, , Japan

Site Status

Site JP81016

Osaka, , Japan

Site Status

Site JP81017

Osaka, , Japan

Site Status

Site JP81018

Osaka, , Japan

Site Status

Site JP81019

Osaka, , Japan

Site Status

Site JP81020

Osaka, , Japan

Site Status

Site JP81004

Saitama, , Japan

Site Status

Site JP81015

Shizuoka, , Japan

Site Status

Site JP81008

Tokyo, , Japan

Site Status

Site JP81009

Tokyo, , Japan

Site Status

Site JP81010

Tokyo, , Japan

Site Status

Countries

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Japan

Other Identifiers

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BE0003

Identifier Type: -

Identifier Source: org_study_id

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