A Randomized, Double-blind, Multi-center, Phase 3 Study to Evaluate the Efficacy and Safety of BR1019A and BR1019B Combination Therapy in Patients With Essential Hypertension and Type 2 Diabetes Mellitus

BR-FDC-CT-301

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

2024-03-01

2025-04-01

2025-04-01

Not yet recruiting

Early phase I

276

Inclusion Criteria: * 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 Criteria: * 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

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2024-02-23