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NCT Number: NCT07373613

A Study 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.

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Key information

Age range

19 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Hanyang University Hospital

Soeul, South Korea

Location contact

Jinho Shin, MD.,PhD

CONTACT

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

One tablet administered alone

Other names: Placebo

BR1400-B

Drug

One tablet administered alone

Other names: Placebo

BR1400-C

Drug

One tablet administered alone

Other names: Placebo

Primary outcomes

  1. Change from baseline to treatment of 8 weeks in MSSBP

    Time frame: 8 weeks

Study contacts

Contact information is provided by the study sponsor or research team.

Soo Hee Kim

CONTACT

[email protected]

+82-2-708-8000

Sponsors and collaborators

Lead sponsor

Boryung Pharmaceutical Co., Ltd

Industry

Registry information

Official study 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

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Jan 28, 2026
Registry last updated
Jan 28, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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