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

Launched by BORYUNG PHARMACEUTICAL CO., LTD · Jan 14, 2024

Keywords

ClinConnect Summary

This clinical trial is testing a new combination therapy, BR1019A and BR1019B, to see how well it works and how safe it is for people with essential hypertension (high blood pressure) and type 2 diabetes. The goal is to find out if this new treatment can help manage these conditions better than existing medications. This study is currently looking for participants, and anyone aged 39 or older who has both type 2 diabetes and high blood pressure may be eligible to join. However, participants will need to stop their current blood pressure and diabetes medications, with the exception of Metformin, during the trial.

If you decide to join the study, you will receive the new treatment and be monitored closely by medical professionals. It's important to note that not everyone can participate; for example, individuals with certain other health issues related to high blood pressure or diabetes may be excluded. This trial is a crucial step in finding better treatment options for people managing these common health conditions, and your involvement could help contribute to important medical knowledge.

Gender

ALL

Eligibility criteria

• 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