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

Cardiovascular Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02570035
• Other study ID #: BE0003
• Status: Completed
• Phase: N/A
• First received: October 6, 2015
• Last updated: October 6, 2015
• Start date: December 2012
• Est. completion date: March 2015

Study information

• Verified date: October 2015
• Source: Astellas Pharma Inc
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Pharmaceuticals and Medical Devices Agency
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 316
• Est. completion date: March 2015
• Est. primary completion date: March 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Cardiovascular Disease
• Cardiovascular Diseases
• Overactive Bladder
• Urinary Bladder, Overactive

Intervention

Drug:
• Mirabegron
oral

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Astellas Pharma Inc

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in electrocardiogram parameters pre- and post- administration of mirabegron		Baseline and up to four weeks	No
Primary	Incidence rate of cardiovascular system adverse reactions		Up to four weeks	No
Primary	Safety assessed by biochemistry laboratory tests		Up to four weeks	No
Primary	Safety assessed by incidence of adverse events		Up to four weeks	No
Secondary	Changes in overactive bladder (OAB) symptoms	Clinical global impression of change from baseline of OAB symptoms by investigator	Baseline and up to four weeks	No