A Study to Evaluate the Efficacy and Safety of BR1019A and BR1019B Combination Therapy
ID: NCT06220773
Our intelligence engine has synthesized this trial record to answer your most important questions in clear, simple terms:
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
Subjects take the investigational products once a day for 12 weeks.
Subjects take the investigational products once a day for 12 weeks.
Subjects take the investigational products once a day for 12 weeks.
Subjects take the investigational products once a day for 12 weeks.
Subjects take the investigational products once a day for 12 weeks.
Subjects take the investigational products once a day for 12 weeks.
Treatment Arms Description
- 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
- 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
Primary Outcome Measures
- The change of mean sitting systolic blood pressure from baseline in BR1019A+BR1019B+BR1019C-1 at Week 12 compared to BR1019A-1+BR1019B+BR1019C-1 — Time Frame: 12 weeks from Baseline Visit
- The change of HbA1c from baseline in BR1019A+BR1019B+BR1019C-1 at Week 12 compared to BR1019A+BR1019B-1+BR1019C-1 — Time Frame: 12 weeks from Baseline Visit
This trial is recruiting at 3 study facilities worldwide. Click below to see if there is a clinic or hospital in your area:
Show All 3 Facilities & Contact Sites
Want to apply or inquire about joining this study? Fill out this simple questionnaire, and our assistant will instantly generate a professional email draft you can copy and send to the central contact coordinator listed above!
View Official Medical/Scientific Title
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