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

Boryung

Status and phase: Completed; Phase 3

Conditions: Primary Hypercholesterolemia; Essential Hypertension

Treatments: Drug: Fimasartan; Drug: Ezetimibe/Atorvastatin; Drug: Fimasartan Placebo; Drug: Ezetimibe/Atorvastatin Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT05930028

BR-FAEC-CT-301

Details and patient eligibility

About

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

Enrollment: 148 patients

Sex: All

Ages: 19+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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148 participants in 3 patient groups

Fimasartan/Ezetimibe/Atorvastatin

Experimental group

Description:

BR1017A+BR1017B(Experimental Group)

Treatment:

Drug: Ezetimibe/Atorvastatin

Drug: Fimasartan

Fimasartan

Active Comparator group

Description:

BR1017A(Control Group 2)

Treatment:

Drug: Ezetimibe/Atorvastatin Placebo

Drug: Fimasartan

Ezetimibe/Atorvastatin

Active Comparator group

Description:

BR1017B(Control Group 1)

Treatment:

Drug: Fimasartan Placebo

Drug: Ezetimibe/Atorvastatin