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

NCT ID: NCT06165250

Last Updated: 2025-11-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 156 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-04-17
• Study Completion Date: 2025-11-11

Brief Summary

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

Conditions

Essential Hypertension; Primary Hypercholesterolemia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

BR1018A-1 + BR1018B + BR1018C

Group Type: EXPERIMENTAL

BR1018A-1

Intervention Type: DRUG

One tablet administered alone

BR1018B

Intervention Type: DRUG

One tablet administered alone

BR1018C

Intervention Type: DRUG

One tablet administered alone

BR1018A + BR1018B-1 + BR1018C

Group Type: ACTIVE_COMPARATOR

BR1018A

Intervention Type: DRUG

One tablet administered alone

BR1018B-1

Intervention Type: DRUG

One tablet administered alone

BR1018C

Intervention Type: DRUG

One tablet administered alone

BR1018A-1 + BR1018B + BR1018C-1

Group Type: ACTIVE_COMPARATOR

BR1018A-1

Intervention Type: DRUG

One tablet administered alone

BR1018B

Intervention Type: DRUG

One tablet administered alone

BR1018C-1

Intervention Type: DRUG

One tablet administered alone

Interventions

BR1018A

One tablet administered alone

Intervention Type: DRUG

BR1018A-1

One tablet administered alone

Intervention Type: DRUG

BR1018B

One tablet administered alone

Intervention Type: DRUG

BR1018B-1

One tablet administered alone

Intervention Type: DRUG

BR1018C

One tablet administered alone

Intervention Type: DRUG

BR1018C-1

One tablet administered alone

Intervention Type: DRUG

Eligibility 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

• Minimum Eligible Age: 19 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Boryung Pharmaceutical Co., Ltd

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Keimyung University Dongsan Hospital

Daegu, , South Korea

Seoul National University Boramae Medical Center

Seoul, , South Korea

Countries

South Korea

Other Identifiers

BR-FAEAC-CT-301

Identifier Type: -

Identifier Source: org_study_id