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NCT06165250CompletedPhase 3

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

Source: ClinicalTrials.gov · Last updated 19 Aug 2026

Brief summary (registry, in English)

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

Status (registry)
Completed
Phase (registry)
Phase 3
Study type
Interventional
Enrollment
151 (actual)
First submitted
3 Dec 2023
Start date
17 Apr 2024
Primary completion date
11 Nov 2025
Lead sponsor
Boryung Pharmaceutical Co., Ltd
NCT number
NCT06165250

What you commit to

  • Study type: Interventional · Phase 3
  • Participants enrolled: 151
  • From 17 Apr 2024 to the primary completion date, 11 Nov 2025
  • 2 sites in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Criteria the registry did not label

  • \<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
    • 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))
    • 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

Age in the registry: 19 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (2)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Keimyung University Dongsan Hospital
Coordinator of this site? Confirm its status
DaeguSouth KoreaUnknown status
Seoul National University Boramae Medical Center
Coordinator of this site? Confirm its status
SeoulSouth KoreaUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.