Actively Recruiting
A Study to Evaluate the Efficacy and Safety of BR1019A and BR1019B Combination Therapy
Led by Boryung Pharmaceutical Co., Ltd · Updated on 2024-05-22
276
Participants Needed
2
Research Sites
45 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
CONDITIONS
Official Title
A Study to Evaluate the Efficacy and Safety of BR1019A and BR1019B Combination Therapy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Have both type 2 diabetes mellitus and essential hypertension
- Agree to stop current antihypertensive and/or oral diabetes medications during the study
- Medically able to discontinue current antihypertensive and/or oral diabetes medications except Metformin during the study
You will not qualify if you...
- History or suspicion of secondary hypertension including conditions like renovascular disease, adrenal hyperfunctions, aortic coarctation, primary hyperaldosteronism, renal artery stenosis, Cushing's syndrome, pheochromocytoma, or polycystic kidney disease
- Presence of clinically significant orthostatic hypotension with symptoms
- Diabetes patients taking renin inhibitors (Aliskiren) or with moderate to severe kidney impairment
- Diabetic nephropathy patients taking ACE inhibitors
- Type 1 diabetes, secondary diabetes, severe insulin-dependent diabetes, diabetic ketoacidosis, or lactic acidosis
- Uncontrolled or severe diabetic complications including microvascular or macrovascular issues
- History of diabetic coma or pre-coma
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 2 locations
1
Severance Hospital
Seoul, South Korea
Actively Recruiting
2
Severance Hospital
Seoul, South Korea
Actively Recruiting
Research Team
S
Shin-young Oh
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
4
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