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

Boryung

Status and phase: Begins enrollment this month; Phase 2

Conditions: Essential Hypertension

Treatments: Drug: BR1400-1; Drug: BR1400-5; Drug: BR1400-B; Drug: BR1400-3; Drug: BR1400-C; Drug: BR1400-A; Drug: BR1400-2; Drug: BR1400-4

Study type: Interventional

Funder types: Industry

Identifiers

NCT07373613

BR-FMS-CT-L202

Details and patient eligibility

About

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.

Enrollment: 330 estimated patients

Sex: All

Ages: 19+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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330 participants in 6 patient groups, including a placebo group

BR1400-1 + BR1400-B + BR1400-C

Experimental group

Description:

Patients will receive tablet BR1400-1 + BR1400-B (Placebo of BR1400-2 \& BR1400-4)+ BR1400-C (Placebo of BR1400-5)

Treatment:

Drug: BR1400-C

Drug: BR1400-B

Drug: BR1400-1

BR1400-A + BR1400-2 + BR1400-C

Experimental group

Description:

Patients will receive BR1400-A (Placebo of BR1400-1 \& BR1400-3) + BR1400-2 + BR1400-C (Placebo of BR1400-5)

Treatment:

Drug: BR1400-2

Drug: BR1400-A

Drug: BR1400-C

BR1400-3 + BR1400-B + BR1400-C

Experimental group

Description:

Patients will receive BR1400-3 + BR1400-B (Placebo of BR1400-2 \& BR1400-4) + BR1400-C (Placebo of BR1400-5)

Treatment:

Drug: BR1400-C

Drug: BR1400-3

Drug: BR1400-B

BR1400-A + BR1400-4 + BR1400-C

Experimental group

Description:

Patients will receive BR1400-A (Placebo of BR1400-1 \& BR1400-3) + BR1400-4 + BR1400-C (Placebo of BR1400-5)

Treatment:

Drug: BR1400-4

Drug: BR1400-A

Drug: BR1400-C

BR1400-A + BR1400-B + BR1400-5

Other group

Description:

Patients will receive BR1400-A (Placebo of BR1400-1 \& BR1400-3) + BR1400-B (Placebo of BR1400-2 \& BR1400-4) + BR1400-5

Treatment:

Drug: BR1400-A

Drug: BR1400-B

Drug: BR1400-5

BR1400-A + BR1400-B + BR1400-C

Placebo Comparator group

Description:

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)

Treatment:

Drug: BR1400-A

Drug: BR1400-C

Drug: BR1400-B