Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Phase 3 study to examine the relation between antihypertensive effect and baseline factors exploratively, compared to olmesartan medoxomil in patients with essential hypertension.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CS-3150 | Experimental | CS-3150 2.5 to 5mg, orally, once daily after breakfast for 12 weeks |
|
| olmesartan medoxomil | Active Comparator | olmesartan medoxomil 10 to 20 mg, orally, once daily after breakfast for 12 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CS-3150 | Drug | CS-3150 2.5mg, oral |
| |
| olmesartan medoxomil |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in 24 hr blood pressure | Relationship between the change from baseline in 24 hr blood pressure (systolic, diastolic, and average blood pressure) and baseline factors frpm baseline to end of Week 12 | baseline to end of Week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in morning, evening, and night blood pressure. | Relationship between the change from baseline in morning, evening, and night blood pressure (systolic, diastolic, and average blood pressure) and baseline factors. | baseline to week 12 |
| Change from baseline in sitting blood pressure |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Global Clinical Leader | Daiichi Sankyo | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tokyo | 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.
Not provided
| ID | Term |
|---|---|
| D000075222 | Essential Hypertension |
| ID | Term |
|---|---|
| D006973 | Hypertension |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C000607547 | esaxerenone |
| D000068557 | Olmesartan Medoxomil |
| ID | Term |
|---|---|
| D007093 | Imidazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Drug |
olmesartan medoxomil 10 mg, oral |
|
|
Relationship between the change from baseline in sitting blood pressure (systolic, diastolic, and average blood pressure) and baseline factors. |
| baseline to week 12 |
| Time course of 24 hr blood pressure and sitting blood pressure | Time course of 24 hr blood pressure and sitting blood pressure (systolic, diastolic, and average blood pressure) | week 12 |
| Proportion of patients achieving 24 hr and sitting blood pressure control | Proportion of patients achieving 24 hr and sitting blood pressure control | week 12 |
| D013777 |
| Tetrazoles |