Clinical trial NCT02570035: Specified Drug Use-results Survey of Betanis Tablets for Patients With Coexisting Cardiovascular Disease
Official title: Protocol for Specified Drug Use-results Survey of Betanis Tablets (for Patients With Coexisting Cardiovascular Disease)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Overactive Bladder
Cardiovascular Disease
Keywords: Mirabegron
Overactive Bladder
Cardiovascular Disease
Lead sponsor: Astellas Pharma Inc
Sponsor class: INDUSTRY
First posted: 2015-10-07
Enrollment: 316
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Overactive bladder patients with current or a history of cardiovascular disease and treated with mirabegron

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.


Eligibility criteria: 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)

Primary outcomes:
measure: Changes in electrocardiogram parameters pre- and post- administration of mirabegron
timeFrame: Baseline and up to four weeks
measure: Incidence rate of cardiovascular system adverse reactions
timeFrame: Up to four weeks
measure: Safety assessed by biochemistry laboratory tests
timeFrame: Up to four weeks
measure: Safety assessed by incidence of adverse events
timeFrame: Up to four weeks
Secondary outcomes:
measure: Changes in overactive bladder (OAB) symptoms
timeFrame: Baseline and up to four weeks
Other outcomes:
Locations:
city: Aichi
country: Japan
facility: Site JP81013
city: Aichi
country: Japan
facility: Site JP81014
city: Chiba
country: Japan
facility: Site JP81005
city: Chiba
country: Japan
facility: Site JP81006
city: Chiba
country: Japan
facility: Site JP81007
city: Fukuoka
country: Japan
facility: Site JP81026
city: Fukuoka
country: Japan
facility: Site JP81027
city: Hokkaido
country: Japan
facility: Site JP81001
city: Hokkaido
country: Japan
facility: Site JP81002
city: Hyogo
country: Japan
facility: Site JP81021
city: Hyogo
country: Japan
facility: Site JP81022
city: Hyogo
country: Japan
facility: Site JP81023
city: Hyogo
country: Japan
facility: Site JP81024
city: Hyogo
country: Japan
facility: Site JP81025
city: Kagoshima
country: Japan
facility: Site JP81028
city: Kanagawa
country: Japan
facility: Site JP81011
city: Kanagawa
country: Japan
facility: Site JP81012
city: Niigata
country: Japan
facility: Site JP81003
city: Osaka
country: Japan
facility: Site JP81016
city: Osaka
country: Japan
facility: Site JP81017
city: Osaka
country: Japan
facility: Site JP81018
city: Osaka
country: Japan
facility: Site JP81019
city: Osaka
country: Japan
facility: Site JP81020
city: Saitama
country: Japan
facility: Site JP81004
city: Shizuoka
country: Japan
facility: Site JP81015
city: Tokyo
country: Japan
facility: Site JP81008
city: Tokyo
country: Japan
facility: Site JP81009
city: Tokyo
country: Japan
facility: Site JP81010
Study officials:
affiliation: Astellas Pharma Inc
name: Medical Director
role: STUDY_DIRECTOR
References: