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The objective of this clinical study is to evaluate the efficacy and safety by comparing the BR1010 treatment group to the fimasartan/amlodipine treatment group at Week 8 in patients with essential hypertension who do not adequately respond to Fimasartan/Amlodipine combination
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BR1010 and Fimasartan/Amlodipine placebo | Experimental | BR1010 or Fimasartan/Amlodipine |
|
| BR1010 placebo and Fimasartan/Amlodipine | Active Comparator | BR1010 or Fimasartan/Amlodipine |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fimasartan/Amlodipine | Drug | Active Comparator: a fixed dose combination of Fimasartan/Amlodipine or placebo |
|
| Measure | Description | Time Frame |
|---|---|---|
| sitting systolic blood pressure | The change of sitting systolic blood pressure | 8weeks from Baseline Visit |
| Measure | Description | Time Frame |
|---|---|---|
| sitting systolic blood pressure | The change of sitting systolic blood pressure | 2weeks and 4weeks from Baseline Visit |
| sitting systolic blood pressure and sitting diastolic blood pressure | The change of sitting systolic blood pressure and sitting diastolic blood pressure |
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Inclusion Criteria:
1.Voluntarily provided a written consent to participate in this clinical study 2.19 years old or above Koreans living in Korea 3.Patients with uncontrolled essential hypertension at screening time(Visit 1)
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Boryung Pharmaceutical Co., Ltd | Seoul | 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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| ID | Term |
|---|---|
| C558933 | fimasartan |
| D017311 | Amlodipine |
| ID | Term |
|---|---|
| D004095 | Dihydropyridines |
| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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|
| 2weeks, 4weeks and 8weeks from Baseline Visit |
| The ratio of subjects who get normalized blood pressure | The ratio of subjects who get normalized blood pressure | 2weeks, 4weeks and 8weeks from Baseline Visit |
| Response Rate | Response Rate | 2weeks, 4weeks and 8weeks from Baseline Visit |