A Study to Evaluate the Efficacy and Safety of Co-administrated BR1018B and BR1018C

Study Overview
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Brief Summary
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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

Official Title
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A Multicenter, Randomized, Double-blind, Active-controlled, Phase 3 Study to Evaluate the Efficacy and Safety of Co-administrated BR1018B and BR1018C in Patients With Essential Hypertension and Primary Hypercholesterolemia

Conditions
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Essential Hypertension, Primary Hypercholesterolemia

Intervention / Treatment
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* Drug: BR1018A
* Drug: BR1018A-1
* Drug: BR1018B
* Drug: BR1018B-1
* Drug: BR1018C
* Drug: BR1018C-1


Participation Criteria
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Eligibility Criteria
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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 Naïve : 140 mmHg ≤ MSSBP < 180 mmHg and MSDBP < 110 mmHg Use antihypertensive drugs : 130 mmHg ≤ MSSBP < 180 mmHg and MSDBP < 110 mmHg 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)) 140 mmHg(or 130 mmHg) ≤ MSSBP < 180 mmHg MSDBP < 110 mmHg 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> Patients with a difference of SiSBP ≥ 20 mmHg and SiDBP ≥ 10 mmHg in blood pressure measured three times on both arms at screening(V1) Patients with blood pressure results showing MSSBP ≥ 180 mmHg or MSDBP ≥ 110 mmHg at screening(V1, both arms) and baseline(V2, selected reference arm) Patients with a history of secondary hypertension or suspected secondary hypertension; (e.g., coarctation of the aorta, hyperaldosteronism, renal artery stenosis, renal hypertension, pheochromocytoma, Cushing's syndrome and polycystic kidney disease, etc.) Patients with a history of secondary hyperlipidemia or suspected hyperlipidemia; (e.g., Chronic renal failure, nephrotic syndrome, dysproteinemia, obstructive liver disease, Cushing's syndrome, hypothyroidism, etc.) Patients with hyportensive shock Patients with orthostatic hypotension accompanied by symptoms

Ages Eligible for Study
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Minimum Age: 19 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: BR1018A-1 + BR1018B + BR1018C<br> | Drug: BR1018A-1<br>* One tablet administered alone<br>Drug: BR1018B<br>* One tablet administered alone<br>Drug: BR1018C<br>* One tablet administered alone<br>|
| Active Comparator: BR1018A + BR1018B-1 + BR1018C<br> | Drug: BR1018A<br>* One tablet administered alone<br>Drug: BR1018B-1<br>* One tablet administered alone<br>Drug: BR1018C<br>* One tablet administered alone<br>|
| Active Comparator: BR1018A-1 + BR1018B + BR1018C-1<br> | Drug: BR1018A-1<br>* One tablet administered alone<br>Drug: BR1018B<br>* One tablet administered alone<br>Drug: BR1018C-1<br>* One tablet administered alone<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 |