Essential HypertensionPhase 2NCT07373613
A Study of BR1400-1, BR1400-2, BR1400-3, BR1400-4, and BR1400-5 in Patients With Essential Hypertension
A Phase 2 study testing BR1400-1, BR1400-2 and BR1400-3 in people with Essential Hypertension, run by Boryung Pharmaceutical Co., Ltd at 1 site in South Korea.
Trial summary
The objective of this clinical trial is to evaluate the antihypertensive efficacy and safety of BR1400-1, BR1400-2, BR1400-3, BR1400-4, and BR1400-5 with essential hypertension. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Essential Hypertension
- What is being tested?
- BR1400-1, BR1400-2 and BR1400-3
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 330 participants
- Where
- 1 siteSouth Korea
- Study dates
- 1 Mar 2026to 1 Feb 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
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
Who may be able to join
- <Screening Visit (V1)>
- Patients with essential hypertension whose mean sitting systolic blood pressure (MSSBP) measured in the reference arm at the screening (Visit 1) meets the following criteria:
- For patients not currently receiving antihypertensive therapy: 140 mmHg ≤ MSSBP < 180 mmHg
- For patients receiving antihypertensive therapy : 130 mmHg ≤ MSSBP < 180 mmHg
- For patients receiving antihypertensive therapy at the screening (Visit 1), those for whom the investigator determines that it is medically appropriate to temporarily discontinue their current antihypertensive treatment during the study.
- <Baseline Visit (V2)>
Show all 9Show fewer
- Patients with essential hypertension whose mean sitting systolic blood pressure (MSSBP) measured in the reference arm at the baseline (Visit 2) prior to randomization meets the following criteria:
- For patients without cardiovascular disease: 140 mmHg ≤ MSSBP < 180 mmHg
- For patients with cardiovascular disease, diabetes with cardiovascular disease, albuminuria, or diabetes with chronic kidney disease (CKD): 130 mmHg ≤ MSSBP < 180 mmHg
Who cannot join
- Patients with blood pressure results showing MSSBP ≥ 180 mmHg or MSDBP ≥ 110 mmHg at screening(V1) and baseline(V2)
- 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 shock
- Patients with orthostatic hypotension accompanied by symptoms
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: A Randomized, Multi-center, Double-Blind, Controlled, Parallel Design, Phase II Study to Evaluate the Efficacy and Safety Administration by Doses of BR1400-1, BR1400-2, BR1400-3, BR1400-4, and BR1400-5 in Patients With Essential Hypertension
The objective of this clinical trial is to evaluate the antihypertensive efficacy and safety of BR1400-1, BR1400-2, BR1400-3, BR1400-4, and BR1400-5 with essential hypertension.
- Conditions
- Essential Hypertension
- Being tested
- BR1400-1, BR1400-2, BR1400-3, BR1400-4, BR1400-5
- Medical subject headings
- Essential Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BR1400-1Drug
One tablet administered alone
BR1400-2Drug
One tablet administered alone
BR1400-3Drug
One tablet administered alone
BR1400-4Drug
One tablet administered alone
BR1400-5Drug
One tablet administered alone
BR1400-ADrug
Also called Placebo
One tablet administered alone
BR1400-BDrug
Also called Placebo
One tablet administered alone
BR1400-CDrug
Also called Placebo
One tablet administered alone
| Study group | Role | What they receive |
|---|---|---|
| BR1400-1 + BR1400-B + BR1400-C | Experimental | Patients will receive tablet BR1400-1 + BR1400-B (Placebo of BR1400-2 \& BR1400-4)+ BR1400-C (Placebo of BR1400-5) Receives: Drug: BR1400-1; Drug: BR1400-B; Drug: BR1400-C |
| BR1400-A + BR1400-2 + BR1400-C | Experimental | Patients will receive BR1400-A (Placebo of BR1400-1 \& BR1400-3) + BR1400-2 + BR1400-C (Placebo of BR1400-5) Receives: Drug: BR1400-2; Drug: BR1400-A; Drug: BR1400-C |
| BR1400-3 + BR1400-B + BR1400-C | Experimental | Patients will receive BR1400-3 + BR1400-B (Placebo of BR1400-2 \& BR1400-4) + BR1400-C (Placebo of BR1400-5) Receives: Drug: BR1400-3; Drug: BR1400-B; Drug: BR1400-C |
| BR1400-A + BR1400-4 + BR1400-C | Experimental | Patients will receive BR1400-A (Placebo of BR1400-1 \& BR1400-3) + BR1400-4 + BR1400-C (Placebo of BR1400-5) Receives: Drug: BR1400-4; Drug: BR1400-A; Drug: BR1400-C |
| BR1400-A + BR1400-B + BR1400-5 | Other | Patients will receive BR1400-A (Placebo of BR1400-1 \& BR1400-3) + BR1400-B (Placebo of BR1400-2 \& BR1400-4) + BR1400-5 Receives: Drug: BR1400-5; Drug: BR1400-A; Drug: BR1400-B |
| BR1400-A + BR1400-B + BR1400-C | Placebo comparator | Patients will receive BR1400-A (Placebo of BR1400-1 \& BR1400-3) + BR1400-B (Placebo of BR1400-2 \& BR1400-4) + BR1400-C (Placebo of BR1400-5) Receives: Drug: BR1400-A; Drug: BR1400-B; Drug: BR1400-C |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline to treatment of 8 weeks in MSSBP
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2026
- Study start1 Mar 2026 (estimated)
- Primary completion1 Feb 2027 (estimated)
- Study completion1 Feb 2027 (estimated)
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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 330 participants (estimated)
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
- NCT07373613
- Sponsor's protocol ID
- BR-FMS-CT-L202
- Status last verified
- Jan 2026
- First submitted
- 20 Jan 2026
- Last updated
- 28 Jan 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Multi-center, Double-Blind, Controlled, Parallel Design, Phase II Study to Evaluate the Efficacy and Safety Administration by Doses of BR1400-1, BR1400-2, BR1400-3, BR1400-4, and BR1400-5 in Patients With Essential Hypertension
- ClinicalTrials.gov ID
- NCT07373613
- Acronym / sponsor ID
- BR-FMS-CT-L202
- Conditions
- Essential Hypertension
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 330 participants (estimated)
- Lead sponsor
- Boryung Pharmaceutical Co., LtdIndustry (pharma, biotech, devices)
- Study start
- 1 Mar 2026 (estimated)
- Primary completion
- 1 Feb 2027 (estimated)
- Study completion
- 1 Feb 2027 (estimated)
- First posted
- 28 Jan 2026 (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 objective of this clinical trial is to evaluate the antihypertensive efficacy and safety of BR1400-1, BR1400-2, BR1400-3, BR1400-4, and BR1400-5 with essential hypertension.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| BR1400-1 + BR1400-B + BR1400-C | Experimental | Drug: BR1400-1, Drug: BR1400-B, Drug: BR1400-CPatients will receive tablet BR1400-1 + BR1400-B (Placebo of BR1400-2 \& BR1400-4)+ BR1400-C (Placebo of BR1400-5) |
| BR1400-A + BR1400-2 + BR1400-C | Experimental | Drug: BR1400-2, Drug: BR1400-A, Drug: BR1400-CPatients will receive BR1400-A (Placebo of BR1400-1 \& BR1400-3) + BR1400-2 + BR1400-C (Placebo of BR1400-5) |
| BR1400-3 + BR1400-B + BR1400-C | Experimental | Drug: BR1400-3, Drug: BR1400-B, Drug: BR1400-CPatients will receive BR1400-3 + BR1400-B (Placebo of BR1400-2 \& BR1400-4) + BR1400-C (Placebo of BR1400-5) |
| BR1400-A + BR1400-4 + BR1400-C | Experimental | Drug: BR1400-4, Drug: BR1400-A, Drug: BR1400-CPatients will receive BR1400-A (Placebo of BR1400-1 \& BR1400-3) + BR1400-4 + BR1400-C (Placebo of BR1400-5) |
| BR1400-A + BR1400-B + BR1400-5 | Other | Drug: BR1400-5, Drug: BR1400-A, Drug: BR1400-BPatients will receive BR1400-A (Placebo of BR1400-1 \& BR1400-3) + BR1400-B (Placebo of BR1400-2 \& BR1400-4) + BR1400-5 |
| BR1400-A + BR1400-B + BR1400-C | Placebo comparator | Drug: BR1400-A, Drug: BR1400-B, Drug: BR1400-CPatients will receive BR1400-A (Placebo of BR1400-1 \& BR1400-3) + BR1400-B (Placebo of BR1400-2 \& BR1400-4) + BR1400-C (Placebo of BR1400-5) |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- <Screening Visit (V1)>
- Patients with essential hypertension whose mean sitting systolic blood pressure (MSSBP) measured in the reference arm at the screening (Visit 1) meets the following criteria:
- For patients not currently receiving antihypertensive therapy: 140 mmHg ≤ MSSBP < 180 mmHg
- For patients receiving antihypertensive therapy : 130 mmHg ≤ MSSBP < 180 mmHg
- For patients receiving antihypertensive therapy at the screening (Visit 1), those for whom the investigator determines that it is medically appropriate to temporarily discontinue their current antihypertensive treatment during the study.
Key exclusion criteria (4 listed)
- Patients with blood pressure results showing MSSBP ≥ 180 mmHg or MSDBP ≥ 110 mmHg at screening(V1) and baseline(V2)
- 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 shock
- Patients with orthostatic hypotension accompanied by symptoms
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 |
|---|---|---|
| BR1400-1One tablet administered alone | Drug | BR1400-1 + BR1400-B + BR1400-C |
| BR1400-2One tablet administered alone | Drug | BR1400-A + BR1400-2 + BR1400-C |
| BR1400-3One tablet administered alone | Drug | BR1400-3 + BR1400-B + BR1400-C |
| BR1400-4One tablet administered alone | Drug | BR1400-A + BR1400-4 + BR1400-C |
| BR1400-5One tablet administered alone | Drug | BR1400-A + BR1400-B + BR1400-5 |
| BR1400-AAlso: PlaceboOne tablet administered alone | Drug | BR1400-A + BR1400-2 + BR1400-C, BR1400-A + BR1400-4 + BR1400-C, BR1400-A + BR1400-B + BR1400-5, BR1400-A + BR1400-B + BR1400-C |
| BR1400-BAlso: PlaceboOne tablet administered alone | Drug | BR1400-1 + BR1400-B + BR1400-C, BR1400-3 + BR1400-B + BR1400-C, BR1400-A + BR1400-B + BR1400-5, BR1400-A + BR1400-B + BR1400-C |
| BR1400-CAlso: PlaceboOne tablet administered alone | Drug | BR1400-1 + BR1400-B + BR1400-C, BR1400-3 + BR1400-B + BR1400-C, BR1400-A + BR1400-2 + BR1400-C, BR1400-A + BR1400-4 + BR1400-C, BR1400-A + BR1400-B + BR1400-C |
Primary outcome
Change from baseline to treatment of 8 weeks in MSSBP
Time frame: 8 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jan 2026.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing BR1400-1, BR1400-2 and BR1400-3 in people with Essential Hypertension, run by Boryung Pharmaceutical Co., Ltd at 1 site 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?
The sponsor lists 9 inclusion and 4 exclusion criteria. 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: opening soon, as of the sponsor's last update on 28 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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. Some participants in this study may receive a placebo. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Soo Hee Kim (+82-2-708-8000, shkim0127@boryung.co.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline to treatment of 8 weeks in MSSBP (time frame: 8 weeks). 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 28 Jan 2026.