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A Study to Evaluate the Efficacy and Safety of BR1019A and BR1019B Combination Therapy

RecruitingPhase 3Ages 19 Years - anyAllBoryung Pharmaceutical Co., Ltd
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In plain words

What the trial is, and whether it could suit you

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

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
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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What it tests

  • BR1019A
  • BR1019B
  • BR1019C
  • BR1019A-1
  • BR1019B-1
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Where

3 sites
Rumah Sakit Jantung dan Pembuluh Darah Harapan Kita (RSJPD)
Jakarta, Indonesia
Severance Hospital
Seoul, South Korea
Severance Hospital
Seoul, South Korea
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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