Essential Hypertension, Type 2 Diabetes Mellitus
Conditions
Brief summary
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
Interventions
DRUGBR1019A
Subjects take the investigational products once a day for 12 weeks.
DRUGBR1019B
Subjects take the investigational products once a day for 12 weeks.
DRUGBR1019C
Subjects take the investigational products once a day for 12 weeks.
DRUGBR1019A-1
Subjects take the investigational products once a day for 12 weeks.
DRUGBR1019B-1
Subjects take the investigational products once a day for 12 weeks.
DRUGBR1019C-1
Subjects take the investigational products once a day for 12 weeks.
Sponsors
Boryung Pharmaceutical Co., Ltd
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 | 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 | 12 weeks from Baseline Visit |
Countries
South Korea
Contacts
Primary ContactShin-young Oh
Outcome results
None listed