Essential Hypertension
Conditions
Brief summary
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
DRUGBR1400-1
One tablet administered alone
DRUGBR1400-2
One tablet administered alone
DRUGBR1400-3
One tablet administered alone
DRUGBR1400-4
One tablet administered alone
DRUGBR1400-5
One tablet administered alone
DRUGBR1400-A
One tablet administered alone
DRUGBR1400-B
One tablet administered alone
DRUGBR1400-C
One tablet administered alone
Sponsors
Boryung Pharmaceutical Co., Ltd
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change from baseline to treatment of 8 weeks in MSSBP | 8 weeks |
Countries
South Korea
Contacts
CONTACTSoo Hee Kim
Outcome results
None listed