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

January 20, 2026 updated by: Boryung Pharmaceutical Co., Ltd

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

330

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • South Korea
      • Soeul, South Korea
        • Hanyang University Hospital
        • Contact:
          • Jinho Shin, MD.,PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: BR1400-1 + BR1400-B + BR1400-C
Patients will receive tablet BR1400-1 + BR1400-B (Placebo of BR1400-2 & BR1400-4)+ BR1400-C (Placebo of BR1400-5)
Drug: BR1400-1
One tablet administered alone
Drug: BR1400-B
One tablet administered alone
Other Names:
  • Placebo
Drug: BR1400-C
One tablet administered alone
Other Names:
  • Placebo
Experimental: BR1400-A + BR1400-2 + BR1400-C
Patients will receive BR1400-A (Placebo of BR1400-1 & BR1400-3) + BR1400-2 + BR1400-C (Placebo of BR1400-5)
Drug: BR1400-2
One tablet administered alone
Drug: BR1400-C
One tablet administered alone
Other Names:
  • Placebo
Drug: BR1400-A
One tablet administered alone
Other Names:
  • Placebo
Experimental: BR1400-3 + BR1400-B + BR1400-C
Patients will receive BR1400-3 + BR1400-B (Placebo of BR1400-2 & BR1400-4) + BR1400-C (Placebo of BR1400-5)
Drug: BR1400-3
One tablet administered alone
Drug: BR1400-B
One tablet administered alone
Other Names:
  • Placebo
Drug: BR1400-C
One tablet administered alone
Other Names:
  • Placebo
Experimental: BR1400-A + BR1400-4 + BR1400-C
Patients will receive BR1400-A (Placebo of BR1400-1 & BR1400-3) + BR1400-4 + BR1400-C (Placebo of BR1400-5)
Drug: BR1400-C
One tablet administered alone
Other Names:
  • Placebo
Drug: BR1400-A
One tablet administered alone
Other Names:
  • Placebo
Drug: BR1400-4
One tablet administered alone
Other: BR1400-A + BR1400-B + BR1400-5
Patients will receive BR1400-A (Placebo of BR1400-1 & BR1400-3) + BR1400-B (Placebo of BR1400-2 & BR1400-4) + BR1400-5
Drug: BR1400-B
One tablet administered alone
Other Names:
  • Placebo
Drug: BR1400-A
One tablet administered alone
Other Names:
  • Placebo
Drug: BR1400-5
One tablet administered alone
Placebo Comparator: BR1400-A + BR1400-B + 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)
Drug: BR1400-B
One tablet administered alone
Other Names:
  • Placebo
Drug: BR1400-C
One tablet administered alone
Other Names:
  • Placebo
Drug: BR1400-A
One tablet administered alone
Other Names:
  • Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change from baseline to treatment of 8 weeks in MSSBP
Time Frame: 8 weeks
8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Boryung Pharmaceutical Co., Ltd

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

March 1, 2026

Primary Completion (Estimated)

February 1, 2027

Study Completion (Estimated)

February 1, 2027

Study Registration Dates

First Submitted

January 20, 2026

First Submitted That Met QC Criteria

January 20, 2026

First Posted (Actual)

January 28, 2026

Study Record Updates

Last Update Posted (Actual)

January 28, 2026

Last Update Submitted That Met QC Criteria

January 20, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BR-FMS-CT-L202

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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