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To examine antihypertensive effect and safety of administration of CS-3150 in combination with ARB or ACE inhibitor in hypertensive patients with type 2 diabetes and albuminuria.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CS-3150 | Experimental | CS-3150 1.25 to 2.5, 5mg, orally, once daily after breakfast for 12 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CS-3150 | Drug | CS-3150 1.25 to 2.5, 5mg, orally |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in sitting systolic and diastolic blood pressure | Change from baseline in sitting systolic and diastolic blood pressure | Baseline to end of Week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Time course of systolic and diastolic blood pressure | Time course of systolic and diastolic blood pressure | Baseline to end of Week 12 |
| Proportion of patients achieving blood pressure control | Proportion of patients achieving blood pressure control |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sanuki-shi | Kagawa-ken | Japan |
De-identified individual participant data (IPD) and applicable supporting clinical trial documents may be available upon request at https://vivli.org/. In cases where clinical trial data and supporting documents are provided pursuant to our company policies and procedures, Daiichi Sankyo will continue to protect the privacy of our clinical trial participants. Details on data sharing criteria and the procedure for requesting access can be found at this web address: https://vivli.org/ourmember/daiichi-sankyo/
Studies for which the medicine and indication have received European Union (EU) and United States (US), and/or Japan (JP) marketing approval on or after 01 January 2014 or by the US or EU or JP Health Authorities when regulatory submissions in all regions are not planned and after the primary study results have been accepted for publication.
Formal request from qualified scientific and medical researchers on IPD and clinical study documents from clinical trials supporting products submitted and licensed in the United States, the European Union and/or Japan from 01 January 2014 and beyond for the purpose of conducting legitimate research. This must be consistent with the principle of safeguarding study participants' privacy and consistent with provision of informed consent.
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| ID | Term |
|---|---|
| D006973 | Hypertension |
| D000419 | Albuminuria |
| D003928 | Diabetic Nephropathies |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D011507 | Proteinuria |
| D014555 | Urination Disorders |
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| ID | Term |
|---|---|
| C000607547 | esaxerenone |
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| Baseline to end of Week 12 |
| Change rate from baseline in urine-albumin-to-creatinine ratio | Change rate from baseline in urine-albumin-to-creatinine ratio. | Baseline to end of Week 12 |
| Time course of urine-albumin-to-creatinine ratio | Time course of urine-albumin-to-creatinine ratio. | Baseline to end of Week 12 |
| D014570 |
| Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D020924 | Urological Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D007674 | Kidney Diseases |
| D048909 | Diabetes Complications |
| D003920 | Diabetes Mellitus |
| D004700 | Endocrine System Diseases |