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The objective of this clinical study is to Evaluate the Efficacy and Safety of BR1019A and BR1019B combination therapy in Patients with Essential Hypertension and Type 2 Diabetes Mellitus
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BR1019A + BR1019B + BR1019C-1 | Experimental |
| |
| BR1019A + BR1019B-1 + BR1019C-1 | Active Comparator |
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| BR1019A-1 + BR1019B + BR1019C-1 | Active Comparator |
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| BR1019A-1 + BR1019B + BR1019C | Other |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BR1019A | Drug | Subjects take the investigational products once a day for 12 weeks. |
|
| Measure | Description | Time Frame |
|---|---|---|
| The change of mean sitting systolic blood pressure from baseline in BR1019A+BR1019B+BR1019C-1 at Week 12 compared to BR1019A-1+BR1019B+BR1019C-1 | 12 weeks from Baseline Visit | |
| The change of HbA1c from baseline in BR1019A+BR1019B+BR1019C-1 at Week 12 compared to BR1019A+BR1019B-1+BR1019C-1 | 12 weeks from Baseline Visit |
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Inclusion Criteria:
Exclusion Criteria:
Those who meet the following criteria
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Shin-young Oh | Contact | +82-2-708-8000 | syoh@boryung.co.kr |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Severance Hospital | Recruiting | Seoul | South Korea |
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| ID | Term |
|---|---|
| D000075222 | Essential Hypertension |
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D006973 | Hypertension |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D003920 | Diabetes Mellitus |
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| BR1019B | Drug | Subjects take the investigational products once a day for 12 weeks. |
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| BR1019C | Drug | Subjects take the investigational products once a day for 12 weeks. |
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| BR1019A-1 | Drug | Subjects take the investigational products once a day for 12 weeks. |
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| BR1019B-1 | Drug | Subjects take the investigational products once a day for 12 weeks. |
|
| BR1019C-1 | Drug | Subjects take the investigational products once a day for 12 weeks. |
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| Severance Hospital | Recruiting | Seoul | South Korea |
|
| D044882 |
| Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |