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To evaluate antihypertensive effect and safety of CS-3150 compared to Eplerenone in patients with essential hypertension.
Primary objective is to evaluate antihypertensive effect and safety of CS-3150 2.5 mg compared to Eplerenone in patients with essential hypertension.
Secondary objective is to evaluate antihypertensive effect and safety of CS-3150 5.0 mg compared to 2.5 mg.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CS-3150 2.5 mg | Experimental | CS-3150 2.5 mg, orally, once daily after breakfast for 12 weeks |
|
| CS-3150 5.0 mg | Experimental | CS-3150 5 mg, orally, once daily after breakfast for 12 weeks |
|
| Eplerenone | Active Comparator | Eplerenone 50 mg, orally, once daily after breakfast for 12 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CS-3150 | Drug |
| ||
| Eplerenone |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in sitting blood pressure | Change from baseline in sitting systolic (SBP) and diastolic blood pressure (DBP). | Baseline to end of Week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in 24 hour average blood pressure | Change from baseline in 24 hour average systolic and diastolic blood pressure. | Baseline to end of Week 12 |
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Inclusion Criteria:
Male and female subjects aged 20 years or older at informed consent
Subjects with essential hypertension satisfying the following blood pressure criteria;
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Global Clinical Leader | Daiichi Sankyo Co., Ltd. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sapporo | Hokkaido | Japan |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31786983 | Derived | Ito S, Itoh H, Rakugi H, Okuda Y, Yoshimura M, Yamakawa S. Double-Blind Randomized Phase 3 Study Comparing Esaxerenone (CS-3150) and Eplerenone in Patients With Essential Hypertension (ESAX-HTN Study). Hypertension. 2020 Jan;75(1):51-58. doi: 10.1161/HYPERTENSIONAHA.119.13569. Epub 2019 Dec 2. |
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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 |
|---|---|
| D000075222 | Essential Hypertension |
| ID | Term |
|---|---|
| D006973 | Hypertension |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| C000607547 | esaxerenone |
| D000077545 | Eplerenone |
| ID | Term |
|---|---|
| D007783 | Lactones |
| D009930 | Organic Chemicals |
| D011283 | Pregnenes |
| D011278 | Pregnanes |
| D013256 |
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|
|
| Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |