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

NCT07373613 | Not Yet Recruiting Phase 2

• 1 other identifier: BR-FMS-CT-L202
• Study Type: interventional
• Target: 330
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Essential Hypertension

Outcome Measures

Primary Outcomes (1)

• Change from baseline to treatment of 8 weeks in MSSBP

  8 weeks

Study Arms (6)

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)

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)

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)

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)

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

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)

Drug: BR1400-A; Drug: BR1400-B; Drug: BR1400-C

Interventions

BR1400-A DRUG

One tablet administered alone

Also known as: Placebo

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-B DRUG

One tablet administered alone

Also known as: Placebo

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-C DRUG

One tablet administered alone

Also known as: Placebo

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

BR1400-1 DRUG

One tablet administered alone

BR1400-1 + BR1400-B + BR1400-C

BR1400-2 DRUG

One tablet administered alone

BR1400-A + BR1400-2 + BR1400-C

BR1400-3 DRUG

One tablet administered alone

BR1400-3 + BR1400-B + BR1400-C

BR1400-4 DRUG

One tablet administered alone

BR1400-A + BR1400-4 + BR1400-C

BR1400-5 DRUG

One tablet administered alone

BR1400-A + BR1400-B + BR1400-5

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \<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

You may not qualify if:

• 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

Sponsors & Collaborators

• Boryung Pharmaceutical Co., Ltd: lead

Study Sites (1)

Hanyang University Hospital

Soeul, South Korea

Location

MeSH Terms

Conditions

Essential Hypertension

Condition Hierarchy (Ancestors)

Hypertension; Vascular Diseases; Cardiovascular Diseases

Central Study Contacts

Soo Hee Kim

CONTACT

+82-2-708-8000; shkim0127@boryung.co.kr

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 20, 2026
• First Posted: January 28, 2026
• Study Start: March 1, 2026
• Primary Completion (Estimated): February 1, 2027
• Study Completion (Estimated): February 1, 2027
• Last Updated: January 28, 2026

Record last verified: 2026-01

Locations

KR (1)