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

ConditionEssential Hypertension
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age19+
SponsorBoryung Pharmaceutical Co., Ltd

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

For patients not currently receiving antihypertensive therapy: 140 mmHg ≤ MSSBP < 180 mmHg

For patients receiving antihypertensive therapy : 130 mmHg ≤ MSSBP < 180 mmHg

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

Disqualifiers

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

Design model

Parallel

Treatments tested in this trial

  • 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

  • BR1400-B

    Drug

    One tablet administered alone

  • BR1400-C

    Drug

    One tablet administered alone

Treatment groups

330 Participants
are divided into 6 treatment groups

6

Treatment groups

See each treatment group below.

Group A: BR1400-1 + BR1400-B + BR1400-CExperimental treatment 3 interventions
Group B: BR1400-A + BR1400-2 + BR1400-CExperimental treatment 3 interventions
Group C: BR1400-3 + BR1400-B + BR1400-CExperimental treatment 3 interventions
Group D: BR1400-A + BR1400-4 + BR1400-CExperimental treatment 3 interventions
Group E: BR1400-A + BR1400-B + BR1400-5Other 3 interventions
Group F: BR1400-A + BR1400-B + BR1400-CPlacebo comparator 3 interventions

Trial outcomes

Primary outcomes

1

Change from baseline to treatment of 8 weeks in MSSBP

Time frame
8 weeks

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Boryung Pharmaceutical Co., Ltd

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: