A Study of BR1400-1, BR1400-2, BR1400-3, BR1400-4, and BR1400-5 in Patients With Essential Hypertension
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: BR1400-1, BR1400-2, BR1400-3, BR1400-4.
- Who it may be relevant to
- Registry conditions: Essential Hypertension. Basic parameters: from 19 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- South Korea
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official 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
Overview
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.
Interventions
- Drug BR1400-1
One tablet administered alone - Drug BR1400-2
One tablet administered alone - Drug BR1400-3
One tablet administered alone - Drug BR1400-4
One tablet administered alone - Drug BR1400-5
One tablet administered alone - Drug BR1400-A
One tablet administered alone - Drug BR1400-B
One tablet administered alone - Drug BR1400-C
One tablet administered alone
Primary outcome measures
- Change from baseline to treatment of 8 weeks in MSSBP [Time frame: 8 weeks]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Treatment
Study locations
South Korea · 1 center
- Hanyang University Hospital — Soeul
Identifiers
NCT: NCT07373613 · BR-FMS-CT-L202