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The objective of this clinical trial is to evaluate the antihypertensive efficacy and safety of BR1400-1, BR1400-2, BR1400-3, BR1400-4, and BR1400-5 with essential hypertension.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BR1400-1 + BR1400-B + BR1400-C | Experimental | Patients will receive tablet BR1400-1 + BR1400-B (Placebo of BR1400-2 & BR1400-4)+ BR1400-C (Placebo of BR1400-5) |
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| BR1400-A + BR1400-2 + BR1400-C | Experimental | Patients will receive BR1400-A (Placebo of BR1400-1 & BR1400-3) + BR1400-2 + BR1400-C (Placebo of BR1400-5) |
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| BR1400-3 + BR1400-B + BR1400-C | Experimental | Patients will receive BR1400-3 + BR1400-B (Placebo of BR1400-2 & BR1400-4) + BR1400-C (Placebo of BR1400-5) |
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| BR1400-A + BR1400-4 + BR1400-C | Experimental | Patients will receive BR1400-A (Placebo of BR1400-1 & BR1400-3) + BR1400-4 + BR1400-C (Placebo of BR1400-5) |
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| BR1400-A + BR1400-B + BR1400-5 | Other | Patients will receive BR1400-A (Placebo of BR1400-1 & BR1400-3) + BR1400-B (Placebo of BR1400-2 & BR1400-4) + BR1400-5 |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BR1400-1 | Drug | One tablet administered alone |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline to treatment of 8 weeks in MSSBP | 8 weeks |
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Inclusion Criteria:
<Screening Visit (V1)>
Patients with essential hypertension whose mean sitting systolic blood pressure (MSSBP) measured in the reference arm at the screening (Visit 1) meets the following criteria:
For patients receiving antihypertensive therapy at the screening (Visit 1), those for whom the investigator determines that it is medically appropriate to temporarily discontinue their current antihypertensive treatment during the study.
<Baseline Visit (V2)>
Patients with essential hypertension whose mean sitting systolic blood pressure (MSSBP) measured in the reference arm at the baseline (Visit 2) prior to randomization meets the following criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Soo Hee Kim | Contact | +82-2-708-8000 | shkim0127@boryung.co.kr |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hanyang University Hospital | Soeul | South Korea |
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| ID | Term |
|---|---|
| D000075222 | Essential Hypertension |
| ID | Term |
|---|---|
| D006973 | Hypertension |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| BR1400-A + BR1400-B + BR1400-C | Placebo Comparator | Patients will receive BR1400-A (Placebo of BR1400-1 & BR1400-3) + BR1400-B (Placebo of BR1400-2 & BR1400-4) + BR1400-C (Placebo of BR1400-5) |
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| BR1400-2 |
| Drug |
One tablet administered alone |
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| BR1400-3 | Drug | One tablet administered alone |
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| BR1400-4 | Drug | One tablet administered alone |
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| BR1400-5 | Drug | One tablet administered alone |
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| BR1400-A | Drug | One tablet administered alone |
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| BR1400-B | Drug | One tablet administered alone |
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| BR1400-C | Drug | One tablet administered alone |
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