A Study of BR1400-1, BR1400-2, BR1400-3, BR1400-4, and BR1400-5 in Patients With Essential Hypertension

NCT07373613 — Phase 2, Not yet recruiting, 330 participants, Boryung Pharmaceutical Co., Ltd

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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

Registry	NCT07373613
Status	Not yet recruiting
Phase	Phase 2
Study type	Interventional; randomized, parallel, masking: double, treatment
Enrollment	330 (Estimated)
Sponsor	Boryung Pharmaceutical Co., Ltd (Industry)
Conditions	Essential Hypertension
Interventions	BR1400-1, BR1400-2, BR1400-3, BR1400-4, BR1400-5, BR1400-A, BR1400-B, BR1400-C (Drug)
Dates	start 2026-03-01 (estimated), primary completion 2027-02-01 (estimated), completion 2027-02-01 (estimated), first posted 2026-01-28, last updated 2026-01-28
Locations	1 site in South Korea

-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.

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+Arms and interventions

Arm	Type	Interventions	Description
BR1400-1 + BR1400-B + BR1400-C	Experimental	Drug: BR1400-1; Drug: BR1400-B; Drug: BR1400-C	Patients 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-C	Patients 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-C	Patients 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-C	Patients 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-B	Patients 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-C	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)

BR1400-1 (Drug): One tablet administered alone
BR1400-2 (Drug): One tablet administered alone
BR1400-3 (Drug): One tablet administered alone
BR1400-4 (Drug): One tablet administered alone
BR1400-5 (Drug): One tablet administered alone
BR1400-A (Drug), also known as Placebo: One tablet administered alone
BR1400-B (Drug), also known as Placebo: One tablet administered alone
BR1400-C (Drug), also known as Placebo: One tablet administered alone

+Outcome measures

Primary outcomes

Change from baseline to treatment of 8 weeks in MSSBP [8 weeks]

+Eligibility

Sex: All, ages: 19 Years to any

Inclusion Criteria:

<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)>

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

Exclusion Criteria:

* 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

+Locations (1)

Facility	City	Country	Status
Hanyang University Hospital	Soeul	South Korea