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

Boryung

Status and phase: Completed; Phase 3

Conditions: Primary Hypercholesterolemia; Essential Hypertension

Treatments: Drug: BR1018B-1; Drug: BR1018B; Drug: BR1018C-1; Drug: BR1018A; Drug: BR1018C; Drug: BR1018A-1

Study type: Interventional

Funder types: Industry

Identifiers

NCT06165250

BR-FAEAC-CT-301

Details and patient eligibility

About

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

Enrollment: 156 patients

Sex: All

Ages: 19+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

<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

    1. Naïve : 140 mmHg ≤ MSSBP < 180 mmHg and MSDBP < 110 mmHg
    2. 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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156 participants in 3 patient groups

BR1018A-1 + BR1018B + BR1018C

Experimental group

Treatment:

Drug: BR1018A-1

Drug: BR1018C

Drug: BR1018B

BR1018A + BR1018B-1 + BR1018C

Active Comparator group

Treatment:

Drug: BR1018C

Drug: BR1018A

Drug: BR1018B-1

BR1018A-1 + BR1018B + BR1018C-1

Active Comparator group

Treatment:

Drug: BR1018A-1

Drug: BR1018C-1

Drug: BR1018B