A Study to Evaluate the Efficacy and Safety of BR1017A and BR1017B Combination Therapy in Essential Hypertension Patients With Primary Hypercholesterolemia
Essential Hypertension, Primary Hypercholesterolemia
About this trial
This is an interventional treatment trial for Essential Hypertension
Eligibility Criteria
<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
Sites / Locations
- Severance HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Experimental
Active Comparator
Active Comparator
Fimasartan/Ezetimibe/Atorvastatin
Fimasartan
Ezetimibe/Atorvastatin
BR1017A+BR1017B(Experimental Group)
BR1017A(Control Group 2)
BR1017B(Control Group 1)