Status:
RECRUITING
A Study to Evaluate the Efficacy and Safety of BR1019A and BR1019B Combination Therapy
Lead Sponsor:
Boryung Pharmaceutical Co., Ltd
Conditions:
Essential Hypertension
Type 2 Diabetes Mellitus
Eligibility:
All Genders
19+ years
Phase:
PHASE3
Brief Summary
The objective of this clinical study is to Evaluate the Efficacy and Safety of BR1019A and BR1019B combination therapy in Patients with Essential Hypertension and Type 2 Diabetes Mellitus
Eligibility Criteria
Inclusion
- Those with type 2 diabetes mellitus \& essential hypertension
- 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
- Those who meet the following 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
Key Trial Info
Start Date :
May 21 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 1 2025
Estimated Enrollment :
276 Patients enrolled
Trial Details
Trial ID
NCT06220773
Start Date
May 21 2024
End Date
April 1 2025
Last Update
May 22 2024
Active Locations (2)
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1
Severance Hospital
Seoul, South Korea
2
Severance Hospital
Seoul, South Korea