Cardiovascular Disease, Overactive Bladder
Conditions
Keywords
Mirabegron, Overactive Bladder, Cardiovascular Disease
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.
Interventions
DRUGMirabegron
oral
Sponsors
Astellas Pharma Inc
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Changes in electrocardiogram parameters pre- and post- administration of mirabegron | Baseline and up to four weeks |
| Incidence rate of cardiovascular system adverse reactions | Up to four weeks |
| Safety assessed by biochemistry laboratory tests | Up to four weeks |
| Safety assessed by incidence of adverse events | Up to four weeks |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Changes in overactive bladder (OAB) symptoms | Baseline and up to four weeks | Clinical global impression of change from baseline of OAB symptoms by investigator |
Countries
Japan
Outcome results
None listed