Essential HypertensionPhase 3NCT06165250
A Study to Evaluate the Efficacy and Safety of Co-administrated BR1018B and BR1018C
A Phase 3 study testing BR1018A, BR1018A-1 and BR1018B in people with Essential Hypertension and Primary Hypercholesterolemia, run by Boryung Pharmaceutical Co., Ltd at 2 sites in South Korea.
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 Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Essential Hypertension, Primary Hypercholesterolemia
- What is being tested?
- BR1018A, BR1018A-1 and BR1018B
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 151 participants
- Where
- 2 sitesSouth Korea
- Study dates
- 17 Apr 2024to 11 Nov 2025
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
<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
Trial locations and contacts
2 sites in 1 country.
South Korea2 sites
Keimyung University Dongsan Hospital
Daegu
Seoul National University Boramae Medical Center
Seoul
About this study
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
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
- Being tested
- BR1018A, BR1018A-1, BR1018B, BR1018B-1, BR1018C
- Medical subject headings
- Essential Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BR1018ADrug
One tablet administered alone
BR1018A-1Drug
One tablet administered alone
BR1018BDrug
One tablet administered alone
BR1018B-1Drug
One tablet administered alone
BR1018CDrug
One tablet administered alone
BR1018C-1Drug
One tablet administered alone
| Study group | Role | What they receive |
|---|---|---|
| BR1018A-1 + BR1018B + BR1018C | Experimental | Not described Receives: Drug: BR1018A-1; Drug: BR1018B; Drug: BR1018C |
| BR1018A + BR1018B-1 + BR1018C | Active comparator | Not described Receives: Drug: BR1018A; Drug: BR1018B-1; Drug: BR1018C |
| BR1018A-1 + BR1018B + BR1018C-1 | Active comparator | Not described Receives: Drug: BR1018A-1; Drug: BR1018B; Drug: BR1018C-1 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 8weeks from Baseline Visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2023
- Study start17 Apr 2024
- Primary completion11 Nov 2025
- Study completion11 Nov 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Essential HypertensionStudies of the same condition, open and under way.
- More trials run by Boryung Pharmaceutical Co., LtdThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 151 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boryung Pharmaceutical Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06165250
- Sponsor's protocol ID
- BR-FAEAC-CT-301
- Status last verified
- Aug 2026
- First submitted
- 3 Dec 2023
- Last updated
- 19 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06165250
- Acronym / sponsor ID
- BR-FAEAC-CT-301
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 151 participants (actual)
- Lead sponsor
- Boryung Pharmaceutical Co., LtdIndustry (pharma, biotech, devices)
- Study start
- 17 Apr 2024 (actual)
- Primary completion
- 11 Nov 2025 (actual)
- Study completion
- 11 Nov 2025 (actual)
- First posted
- 11 Dec 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BR1018AOne tablet administered alone | Drug | BR1018A + BR1018B-1 + BR1018C |
| BR1018A-1One tablet administered alone | Drug | BR1018A-1 + BR1018B + BR1018C, BR1018A-1 + BR1018B + BR1018C-1 |
| BR1018BOne tablet administered alone | Drug | BR1018A-1 + BR1018B + BR1018C, BR1018A-1 + BR1018B + BR1018C-1 |
| BR1018B-1One tablet administered alone | Drug | BR1018A + BR1018B-1 + BR1018C |
| BR1018COne tablet administered alone | Drug | BR1018A + BR1018B-1 + BR1018C, BR1018A-1 + BR1018B + BR1018C |
| BR1018C-1One tablet administered alone | Drug | BR1018A-1 + BR1018B + BR1018C-1 |
Primary outcome
Mean sitting systolic blood pressure
Time frame: 8weeks from Baseline Visit
The change of mean sitting systolic blood pressure from baseline in BR1018A-1+BR1018B+BR1018C at Week 8 compared to BR1018A+BR1018B-1+BR1018C
LDL-C
Time frame: 8weeks from Baseline Visit
The percent of change in LDL-C from baseline in BR1018A-1+BR1018B+BR1018C at Week 8 compared to BR1018A-1+BR1018B+BR1018C-1
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing BR1018A, BR1018A-1 and BR1018B in people with Essential Hypertension and Primary Hypercholesterolemia, run by Boryung Pharmaceutical Co., Ltd at 2 sites in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean sitting systolic blood pressure (time frame: 8weeks from Baseline Visit). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Aug 2026.