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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
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

Full criteria on ClinicalTrials.gov

Sites (2)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Rumah Sakit Jantung dan Pembuluh Darah Harapan Kita (RSJPD)
Coordinator of this site? Confirm its status
JakartaIndonesiaRecruiting
Severance hospital
Coordinator of this site? Confirm its status
SeoulSouth KoreaRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.