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

Completed

• Conditions: Cardiovascular Disease; Overactive Bladder
• Interventions: Drug: Mirabegron

• Registration Number: NCT02570035
• Lead Sponsor: Astellas Pharma Inc

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-12
• Primary Completion: 2015-03
• Study Completion: 2015-03
• Status Verified: 2015-10
• Study First Submitted: 2015-10-06
• Study First Submitted QC: 2015-10-06
• Last Update Submitted: 2015-10-06
• Study First Posted: 2015-10-07
• Last Update Posted: 2015-10-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 316

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Mirabegron group	Mirabegron	Subjects with overactive bladder and cardiovascular disease prescribed mirabegron

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Changes in overactive bladder (OAB) symptoms	Baseline and up to four weeks	Clinical global impression of change from baseline of OAB symptoms by investigator

Trial Locations

Locations (28)

Site JP81007; 🇯🇵 Chiba, Japan

Site JP81001; 🇯🇵 Hokkaido, Japan

Site JP81025; 🇯🇵 Hyogo, Japan

Site JP81012; 🇯🇵 Kanagawa, Japan

Site JP81017; 🇯🇵 Osaka, Japan

Site JP81028; 🇯🇵 Kagoshima, Japan

Site JP81003; 🇯🇵 Niigata, Japan

Site JP81018; 🇯🇵 Osaka, Japan

Site JP81020; 🇯🇵 Osaka, Japan

Site JP81026; 🇯🇵 Fukuoka, Japan

Site JP81014; 🇯🇵 Aichi, Japan

Site JP81013; 🇯🇵 Aichi, Japan

Site JP81027; 🇯🇵 Fukuoka, Japan

Site JP81002; 🇯🇵 Hokkaido, Japan

Site JP81021; 🇯🇵 Hyogo, Japan

Site JP81022; 🇯🇵 Hyogo, Japan

Site JP81004; 🇯🇵 Saitama, Japan

Site JP81011; 🇯🇵 Kanagawa, Japan

Site JP81019; 🇯🇵 Osaka, Japan

Site JP81005; 🇯🇵 Chiba, Japan

Site JP81023; 🇯🇵 Hyogo, Japan

Site JP81015; 🇯🇵 Shizuoka, Japan

Site JP81008; 🇯🇵 Tokyo, Japan

Site JP81009; 🇯🇵 Tokyo, Japan

Site JP81006; 🇯🇵 Chiba, Japan

Site JP81024; 🇯🇵 Hyogo, Japan

Site JP81016; 🇯🇵 Osaka, Japan

Site JP81010; 🇯🇵 Tokyo, Japan