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

NCT06165250 | Completed Phase 3

• 1 other identifier: BR-FAEAC-CT-301
• Study Type: interventional
• Target: 156
• Locations: 1 country
• Sites: 2

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

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (3)

BR1018A-1 + BR1018B + BR1018C

EXPERIMENTAL

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

BR1018A + BR1018B-1 + BR1018C

ACTIVE COMPARATOR

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

BR1018A-1 + BR1018B + BR1018C-1

ACTIVE COMPARATOR

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

Interventions

BR1018A DRUG

One tablet administered alone

BR1018A + BR1018B-1 + BR1018C

BR1018A-1 DRUG

One tablet administered alone

BR1018A-1 + BR1018B + BR1018C; BR1018A-1 + BR1018B + BR1018C-1

BR1018B DRUG

One tablet administered alone

BR1018A-1 + BR1018B + BR1018C; BR1018A-1 + BR1018B + BR1018C-1

BR1018B-1 DRUG

One tablet administered alone

BR1018A + BR1018B-1 + BR1018C

BR1018C DRUG

One tablet administered alone

BR1018A + BR1018B-1 + BR1018C; BR1018A-1 + BR1018B + BR1018C

BR1018C-1 DRUG

One tablet administered alone

BR1018A-1 + BR1018B + BR1018C-1

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• Naïve : 140 mmHg ≤ MSSBP \< 180 mmHg and MSDBP \< 110 mmHg
• 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))
• 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))

You may not qualify if:

• 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

Sponsors & Collaborators

• Boryung Pharmaceutical Co., Ltd: lead

Study Sites (2)

Keimyung University Dongsan Hospital

Daegu, South Korea

Location

Seoul National University Boramae Medical Center

Seoul, South Korea

Location

MeSH Terms

Conditions

Essential Hypertension

Condition Hierarchy (Ancestors)

Hypertension; Vascular Diseases; Cardiovascular Diseases

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 3, 2023
• First Posted: December 11, 2023
• Study Start: April 17, 2024
• Primary Completion: November 11, 2025
• Study Completion: November 11, 2025
• Last Updated: November 25, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

KR (2)