A Study to Evaluate the Efficacy and Safety of BR1019A and BR1019B Combination Therapy
NCT ID: NCT06220773
Last Updated: 2024-05-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE3
276 participants
INTERVENTIONAL
2024-05-21
2025-04-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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BR1019A + BR1019B + BR1019C-1
BR1019A
Subjects take the investigational products once a day for 12 weeks.
BR1019B
Subjects take the investigational products once a day for 12 weeks.
BR1019C-1
Subjects take the investigational products once a day for 12 weeks.
BR1019A + BR1019B-1 + BR1019C-1
BR1019A
Subjects take the investigational products once a day for 12 weeks.
BR1019B-1
Subjects take the investigational products once a day for 12 weeks.
BR1019C-1
Subjects take the investigational products once a day for 12 weeks.
BR1019A-1 + BR1019B + BR1019C-1
BR1019B
Subjects take the investigational products once a day for 12 weeks.
BR1019A-1
Subjects take the investigational products once a day for 12 weeks.
BR1019C-1
Subjects take the investigational products once a day for 12 weeks.
BR1019A-1 + BR1019B + BR1019C
BR1019B
Subjects take the investigational products once a day for 12 weeks.
BR1019C
Subjects take the investigational products once a day for 12 weeks.
BR1019A-1
Subjects take the investigational products once a day for 12 weeks.
Interventions
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BR1019A
Subjects take the investigational products once a day for 12 weeks.
BR1019B
Subjects take the investigational products once a day for 12 weeks.
BR1019C
Subjects take the investigational products once a day for 12 weeks.
BR1019A-1
Subjects take the investigational products once a day for 12 weeks.
BR1019B-1
Subjects take the investigational products once a day for 12 weeks.
BR1019C-1
Subjects take the investigational products once a day for 12 weeks.
Eligibility Criteria
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Inclusion Criteria
* Those who agree to discontinue existing antihypertensive and/or oral hypoglycemic drugs during the clinical trial
* Those who are judged medically reasonable by investigator to be able to discontinue existing antihypertensive and/or oral hypoglycemic drugs(except for Metformin) during the clinical trial
Exclusion Criteria
* Those with a history of secondary hypertension or suspected secondary hypertension; (Including but not limited to; e.g., renovascular disease, adrenal medullary and cortical hyperfunctions, coarctation of the aorta, primary hyperaldosteronism, unilateral or bilateral renal artery stenosis, Cushing's syndrome, pheochromocytoma and polycystic kidney disease, etc.)
* Those with clinical significant orthostatic hypotension accompanied by symptoms
* Those with diabetes mellitus taking renin inhibitors(Aliskiren) or moderate to severe renal impairment
* Those with diabetic nephropathy taking ACE inhibitors
* Those with type 1 diabetes mellitus, secondary diabetes mellitus, severe insulin-dependent diabetes, diabetic ketoacidosis or lactic acidosis
* Those with uncontrolled, severe diabetic complications (Micro-vascular complications(e.g., nephropathy, retinopathy, neuropathy, etc.), Macro-vascular complications)
* Diabetic coma or pre-coma
19 Years
ALL
No
Sponsors
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Boryung Pharmaceutical Co., Ltd
INDUSTRY
Responsible Party
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Locations
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Severance Hospital
Seoul, , South Korea
Severance Hospital
Seoul, , South Korea
Countries
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Central Contacts
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Facility Contacts
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Seok-min Kang, M.D., Ph.D.
Role: primary
Bong-Soo Cha, M.D., Ph.D.
Role: primary
Other Identifiers
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BR-FDC-CT-301
Identifier Type: -
Identifier Source: org_study_id
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