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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Mirabegron group | Subjects with overactive bladder and cardiovascular disease prescribed mirabegron |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mirabegron | Drug | oral |
|
|
| Measure | Description | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in overactive bladder (OAB) symptoms | Clinical global impression of change from baseline of OAB symptoms by investigator | Baseline and up to four weeks |
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Inclusion Criteria:
Exclusion Criteria:
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Overactive bladder patients with current or a history of cardiovascular disease and treated with mirabegron
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| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Astellas Pharma Inc | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Site JP81013 | Aichi | Japan | ||||
| Site JP81014 |
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| 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 | Hyōgo | Japan |
| Site JP81022 | Hyōgo | Japan |
| Site JP81023 | Hyōgo | Japan |
| Site JP81024 | Hyōgo | Japan |
| Site JP81025 | Hyōgo | 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 | Japan |
| ID | Term |
|---|---|
| D053201 | Urinary Bladder, Overactive |
| D002318 | Cardiovascular Diseases |
| ID | Term |
|---|---|
| D001745 | Urinary Bladder Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D059411 | Lower Urinary Tract Symptoms |
| D020924 | Urological Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| C520025 | mirabegron |
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