NCT06220773RecruitingPhase 3
A Study to Evaluate the Efficacy and Safety of BR1019A and BR1019B Combination Therapy
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
Source: ClinicalTrials.gov · Last updated 16 Oct 2026
Brief summary (registry, in English)
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
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 276 (estimated)
- First submitted
- 14 Jan 2024
- Start date
- 21 May 2024
- Primary completion date
- Dec 2026
- Lead sponsor
- Boryung Pharmaceutical Co., Ltd
- Diseases
- High blood pressure, Type 2 diabetes
- NCT number
- NCT06220773
What you commit to
- Study type: Interventional · Phase 3
- Planned participants: 276
- From 21 May 2024 to the primary completion date, Dec 2026
- 2 sites in 2 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- 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
Who the study is looking for
- 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
Age in the registry: 19 years to - · Sex: All · Does not accept healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Rumah Sakit Jantung dan Pembuluh Darah Harapan Kita (RSJPD) Coordinator of this site? Confirm its status | Jakarta | Indonesia | Recruiting |
| Severance hospital Coordinator of this site? Confirm its status | Seoul | South Korea | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.