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A Study to Evaluate the Efficacy and Safety of BR1019A and BR1019B Combination Therapy
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
ClinicalTrials.gov IDNCT06220773
PhasePHASE3
Enrollment276
SponsorBoryung Pharmaceutical Co., Ltd
Age19 Years and older
SexALL
Conditions studied
Essential Hypertension, Type 2 Diabetes Mellitus
About this study
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
- Drug: BR1019A — Subjects take the investigational products once a day for 12 weeks.
- Drug: BR1019B — Subjects take the investigational products once a day for 12 weeks.
- Drug: BR1019C — Subjects take the investigational products once a day for 12 weeks.
- Drug: BR1019A-1 — Subjects take the investigational products once a day for 12 weeks.
- Drug: BR1019B-1 — Subjects take the investigational products once a day for 12 weeks.
- Drug: BR1019C-1 — Subjects take the investigational products once a day for 12 weeks.
Primary outcomes
- 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)
Eligibility information
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
Study locations
- Rumah Sakit Jantung dan Pembuluh Darah Harapan Kita (RSJPD), Jakarta, DKI Jakarta 11420 Indonesia
- Severance Hospital, Seoul, South Korea
- Severance Hospital, Seoul, South Korea
Before you participate: Varda Clinical is an independent discovery tool, not the study sponsor or a medical provider. Eligibility can only be determined by the official study team. Discuss potential risks and benefits with a qualified healthcare professional.
Source: ClinicalTrials.gov. Record last refreshed by Varda Clinical: 2026-10-22.