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

Essential Hypertension Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06165250
• Other study ID #: BR-FAEAC-CT-301
• Status: Recruiting
• Phase: Phase 3
• Start date: April 17, 2024
• Est. completion date: April 2025

Study information

• Verified date: April 2024
• Source: Boryung Pharmaceutical Co., Ltd
• Contact: Shin-young Oh
• Phone: +82-2-708-8000
• Email: syoh[@]boryung.co.kr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 156
• Est. completion date: April 2025
• Est. primary completion date: April 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

<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

Related Conditions & MeSH terms

• Essential Hypertension
• Hypercholesterolemia
• Hypertension
• Primary Hypercholesterolemia

Intervention

Drug:
• BR1018A
One tablet administered alone
• BR1018A-1
One tablet administered alone
• BR1018B
One tablet administered alone
• BR1018B-1
One tablet administered alone
• BR1018C
One tablet administered alone
• BR1018C-1
One tablet administered alone

Locations

Country	Name	City	State
Korea, Republic of	Keimyung University Dongsan Hospital	Daegu
Korea, Republic of	Seoul National University Boramae Medical Center	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Boryung Pharmaceutical Co., Ltd

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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