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The purpose of this clinical trial is to evaluate the efficacy and safety of co-administrated BR1018B and BR1018C in patients with essential hypertension and primary hypercholesterolemia
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BR1018A-1 + BR1018B + BR1018C | Experimental |
| |
| BR1018A + BR1018B-1 + BR1018C | Active Comparator |
| |
| BR1018A-1 + BR1018B + BR1018C-1 | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BR1018A | Drug | One tablet administered alone |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Mean sitting systolic blood pressure | The change of mean sitting systolic blood pressure from baseline in BR1018A-1+BR1018B+BR1018C at Week 8 compared to BR1018A+BR1018B-1+BR1018C | 8weeks from Baseline Visit |
| LDL-C | The percent of change in LDL-C from baseline in BR1018A-1+BR1018B+BR1018C at Week 8 compared to BR1018A-1+BR1018B+BR1018C-1 | 8weeks from Baseline Visit |
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<Inclusion Criteria>
Screening Visit (V1)
Patients with essential hypertension and primary hypercholesterolemia
If patients are being treated with antihypertensive/antihyperlipidemic drugs at screening, they should be determined to be medically reasonable by investigator about discontinuing existing antihypertensive/antihyperlipidemic drugs during the clinical trial
Patients under the following criteria at screening:
Patients who meet a fasting triglyceride (TG) < 400 mg/dL and LDL-C ≤ 250 mg/dL
Patients who meet the following criteria, depending on whether antihypertensive drugs were administered within the last 4 weeks
Baseline Visit (V2)
Patients who meet the following criteria of blood pressure measured in selected reference arm at baseline (According to the clinical situation of each subject, Follow the blood pressure standards(Refer to 2022 The Korean Society of Hypertension Guideline))
Patients who meet fasting serum lipid profile test levels (LDL-C and TG) correspond to cardiovascular risk and risk factors at baseline (Refer to 2022 Korean Guidelines for the Management of Dyslipidemia (the 5th edition))
<Exclusion Criteria>
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Keimyung University Dongsan Hospital | Daegu | South Korea | ||||
| Seoul National University Boramae Medical Center |
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| ID | Term |
|---|---|
| D000075222 | Essential Hypertension |
| ID | Term |
|---|---|
| D006973 | Hypertension |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| BR1018A-1 |
| Drug |
One tablet administered alone |
|
| BR1018B | Drug | One tablet administered alone |
|
| BR1018B-1 | Drug | One tablet administered alone |
|
| BR1018C | Drug | One tablet administered alone |
|
| BR1018C-1 | Drug | One tablet administered alone |
|
| Seoul |
| South Korea |