A Study to Evaluate the Efficacy and Safety of BR1017A and BR1017B Combination Therapy in Essential Hypertension Patients With Primary Hypercholesterolemia

Study Overview
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Brief Summary
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The objective of this clinical study is to evaluate the efficacy and safety by comparing BR1017A+BR1017B treatment group to BR1017A treatment group and BR1017B treatment group respectively at Week 8 in essential hypertension patients with primary hypercholesterolemia

Official Title
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A Randomized, Double-blind, Multi-center, Phase III Trial to Evaluate the Efficacy and Safety of BR1017A and BR1017B Combination Therapy in Essential Hypertension Patients With Primary Hypercholesterolemia

Conditions
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Essential Hypertension, Primary Hypercholesterolemia

Intervention / Treatment
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* Drug: Fimasartan
* Drug: Ezetimibe/Atorvastatin
* Drug: Fimasartan Placebo
* Drug: Ezetimibe/Atorvastatin Placebo


Participation Criteria
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Eligibility Criteria
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<Inclusion Criteria> Screening Patients with essential hypertension and primary hypercholesterolemia If patients are being treated with antihypertensive/antihyperlipidemic drugs at screening (V1), they should be determined to be medically reasonable by investigator about discontinuing existing antihypertensive/ antihyperlipidemic drugs during the clinical trial Patients who have an fasting triglyceride (TG) < 400 mg/dL and LDL-C ≤ 250 mg/dL at Screening (V1) Voluntarily provided a written consent to participate in this clinical study Able to understand this study, be cooperative in the execution of the study, and participate in the study until its completion Randomization Patients who meet the following criteria of blood pressure measured in selected reference arm before randomization at baseline(V3) 140 mmHg ≤ MSSBP < 180 mmHg MSDBP < 110 mmHg Patients who meet the criteria of fasting serum lipid levels and risk factors at pre-baseline (V2) after undergoing the therapeutic lifestyle change (TLC) Patients who have an fasting triglyceride (TG) < 400 mg/dL and LDL-C ≤ 250 mg/dL after undergoing the therapeutic lifestyle change (TLC) for at least 4 weeks before pre-baseline (V2) <Exclusion Criteria> Patients with blood pressure results showing MSSBP ≥ 180 mmHg or MSDBP ≥ 110 mmHg in the selected reference arm at screening(V1) or Baseline(V3) Patients with a difference of MSSBP ≥ 20 mmHg and MSDBP ≥ 10 mmHg in blood pressure measured three times on both arms at screening(V1) Patients with past history and comorbidities at screening(V1) under the following criteria: Patients with secondary hypertension: Secondary hypertension is not limited to the following diseases; (e.g., coarctation of the aorta, hyperaldosteronism, renal artery stenosis, Cushing's syndrome, pheochromocytoma and polycystic kidney disease, etc.) Patients with secondary hyperlipidemia: Secondary hyperlipidemia is not limited to the following diseases; (e.g., Chronic renal failure, nephrotic syndrome, obstructive liver disease, hypothyroidism, dysproteinemia, etc.) 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: Fimasartan/Ezetimibe/Atorvastatin<br>BR1017A+BR1017B(Experimental Group) | Drug: Fimasartan<br>* Subjects take the investigational products once a day for 8 weeks.<br>* Other names: BR1017A;Drug: Ezetimibe/Atorvastatin<br>* Subjects take the investigational products once a day for 8 weeks.<br>* Other names: BR1017B;|
| Active Comparator: Fimasartan<br>BR1017A(Control Group 2) | Drug: Fimasartan<br>* Subjects take the investigational products once a day for 8 weeks.<br>* Other names: BR1017A;Drug: Ezetimibe/Atorvastatin Placebo<br>* Subjects take the investigational products once a day for 8 weeks.<br>* Other names: BR1017B-1;|
| Active Comparator: Ezetimibe/Atorvastatin<br>BR1017B(Control Group 1) | Drug: Ezetimibe/Atorvastatin<br>* Subjects take the investigational products once a day for 8 weeks.<br>* Other names: BR1017B;Drug: Fimasartan Placebo<br>* Subjects take the investigational products once a day for 8 weeks.<br>* Other names: BR1017A-1;|

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 BR1017A+BR1017B at Week 8 compared to BR1017B | 8weeks from Baseline Visit | 
| LDL-C | The percent of change in LDL-C from baseline in BR1017A+BR1017B at Week 8 compared to BR1017A | 8weeks from Baseline Visit | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| LDL-C | The percent of change in LDL-C from baseline in BR1017A+BR1017B at Week 8 compared to BR1017B | 8weeks from Baseline Visit | 
| Mean sitting systolic blood pressure | The change of mean sitting systolic blood pressure from baseline in BR1017A+BR1017B at Week 8 compared to BR1017A | 8weeks from Baseline Visit |