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

A Multicenter, Randomized, Double-blind, Active-controlled, Phase 3 Study to Evaluate the Efficacy and Safety of Co-administrated BR1018B and BR1018C in Patients With Essential Hypertension and Primary Hypercholesterolemia

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

Study Overview

• Status: Completed
• Conditions: Essential Hypertension; Primary Hypercholesterolemia
• Intervention / Treatment: Drug: BR1018A-1; Drug: BR1018B; Drug: BR1018C; Drug: BR1018A; Drug: BR1018B-1; Drug: BR1018C-1

• Study Type: Interventional
• Enrollment (Actual): 156
• Phase: Phase 3

Contacts and Locations

Study Locations

• South Korea
  • Daegu, South Korea
    • Keimyung University Dongsan Hospital
  • Seoul, South Korea
    • Seoul National University Boramae Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

<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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: BR1018A-1 + BR1018B + BR1018C	Drug: BR1018A-1; One tablet administered alone; Drug: BR1018B; One tablet administered alone; Drug: BR1018C; One tablet administered alone
Active Comparator: BR1018A + BR1018B-1 + BR1018C	Drug: BR1018C; One tablet administered alone; Drug: BR1018A; One tablet administered alone; Drug: BR1018B-1; One tablet administered alone
Active Comparator: BR1018A-1 + BR1018B + BR1018C-1	Drug: BR1018A-1; One tablet administered alone; Drug: BR1018B; One tablet administered alone; Drug: BR1018C-1; One tablet administered alone

What is the study measuring?

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 BR1018A-1+BR1018B+BR1018C at Week 8 compared to BR1018A+BR1018B-1+BR1018C	8weeks from Baseline Visit
LDL-C	The percent of change in LDL-C from baseline in BR1018A-1+BR1018B+BR1018C at Week 8 compared to BR1018A-1+BR1018B+BR1018C-1	8weeks from Baseline Visit

Collaborators and Investigators

• Sponsor: Boryung Pharmaceutical Co., Ltd

Study record dates

Study Major Dates

• Study Start (Actual): April 17, 2024
• Primary Completion (Actual): November 11, 2025
• Study Completion (Actual): November 11, 2025

Study Registration Dates

• First Submitted: December 3, 2023
• First Submitted That Met QC Criteria: December 3, 2023
• First Posted (Actual): December 11, 2023

Study Record Updates

• Last Update Posted (Actual): November 25, 2025
• Last Update Submitted That Met QC Criteria: November 23, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Hypertension; Essential Hypertension
• Other Study ID Numbers: BR-FAEAC-CT-301

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No