Essential HypertensionPhase 3NCT06220773
A Study to Evaluate the Efficacy and Safety of BR1019A and BR1019B Combination Therapy
A Phase 3 study testing BR1019A, BR1019B and BR1019C in people with Essential Hypertension and Type 2 Diabetes Mellitus, run by Boryung Pharmaceutical Co., Ltd at 3 sites in 2 countries.
Trial 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 Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Essential Hypertension, Type 2 Diabetes Mellitus
- What is being tested?
- BR1019A, BR1019B and BR1019C
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 276 participants
- Where
- 3 sitesin 2 countries
- Study dates
- 21 May 2024to Dec 2026
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
3 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
3 sites in 2 countries
South Korea2 sites, 2 recruiting
- Recruiting
Severance Hospital
Seoul
Seok-min Kang, M.D., Ph.D.
- Recruiting
Severance Hospital
Seoul
Bong-Soo Cha, M.D., Ph.D.
Indonesia1 site, 1 recruiting
- Recruiting
Rumah Sakit Jantung dan Pembuluh Darah Harapan Kita (RSJPD)
Jakarta, DKI Jakarta, 11420
dr. Bambang Widyantoro, Sp.JP(K), PhD, (+62)21 1500034, cru@pjnhk.go.id
About this study
Official title: 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
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
- Essential Hypertension, Type 2 Diabetes Mellitus
- Being tested
- BR1019A, BR1019B, BR1019C, BR1019A-1, BR1019B-1
- Medical subject headings
- Essential Hypertension, Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BR1019ADrug
Subjects take the investigational products once a day for 12 weeks.
BR1019BDrug
Subjects take the investigational products once a day for 12 weeks.
BR1019CDrug
Subjects take the investigational products once a day for 12 weeks.
BR1019A-1Drug
Subjects take the investigational products once a day for 12 weeks.
BR1019B-1Drug
Subjects take the investigational products once a day for 12 weeks.
BR1019C-1Drug
Subjects take the investigational products once a day for 12 weeks.
| Study group | Role | What they receive |
|---|---|---|
| BR1019A + BR1019B + BR1019C-1 | Experimental | Not described Receives: Drug: BR1019A; Drug: BR1019B; Drug: BR1019C-1 |
| BR1019A + BR1019B-1 + BR1019C-1 | Active comparator | Not described Receives: Drug: BR1019A; Drug: BR1019B-1; Drug: BR1019C-1 |
| BR1019A-1 + BR1019B + BR1019C-1 | Active comparator | Not described Receives: Drug: BR1019B; Drug: BR1019A-1; Drug: BR1019C-1 |
| BR1019A-1 + BR1019B + BR1019C | Other | Not described Receives: Drug: BR1019B; Drug: BR1019C; Drug: BR1019A-1 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 12 weeks from Baseline Visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jan 2024
- Study start21 May 2024
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Essential HypertensionStudies of the same condition, open and under way.
- More trials run by Boryung Pharmaceutical Co., LtdThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 276 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Boryung Pharmaceutical Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06220773
- Sponsor's protocol ID
- BR-FDC-CT-301
- Status last verified
- Oct 2026
- First submitted
- 14 Jan 2024
- Last updated
- 16 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06220773
- Acronym / sponsor ID
- BR-FDC-CT-301
- Conditions
- Essential Hypertension, Type 2 Diabetes Mellitus
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 276 participants (estimated)
- Lead sponsor
- Boryung Pharmaceutical Co., LtdIndustry (pharma, biotech, devices)
- Study start
- 21 May 2024 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 24 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| BR1019A + BR1019B + BR1019C-1 | Experimental | Drug: BR1019A, Drug: BR1019B, Drug: BR1019C-1 |
| BR1019A + BR1019B-1 + BR1019C-1 | Active comparator | Drug: BR1019A, Drug: BR1019B-1, Drug: BR1019C-1 |
| BR1019A-1 + BR1019B + BR1019C-1 | Active comparator | Drug: BR1019B, Drug: BR1019A-1, Drug: BR1019C-1 |
| BR1019A-1 + BR1019B + BR1019C | Other | Drug: BR1019B, Drug: BR1019C, Drug: BR1019A-1 |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (8 listed)
- Those who meet the following criteria
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BR1019ASubjects take the investigational products once a day for 12 weeks. | Drug | BR1019A + BR1019B + BR1019C-1, BR1019A + BR1019B-1 + BR1019C-1 |
| BR1019BSubjects take the investigational products once a day for 12 weeks. | Drug | BR1019A + BR1019B + BR1019C-1, BR1019A-1 + BR1019B + BR1019C, BR1019A-1 + BR1019B + BR1019C-1 |
| BR1019CSubjects take the investigational products once a day for 12 weeks. | Drug | BR1019A-1 + BR1019B + BR1019C |
| BR1019A-1Subjects take the investigational products once a day for 12 weeks. | Drug | BR1019A-1 + BR1019B + BR1019C, BR1019A-1 + BR1019B + BR1019C-1 |
| BR1019B-1Subjects take the investigational products once a day for 12 weeks. | Drug | BR1019A + BR1019B-1 + BR1019C-1 |
| BR1019C-1Subjects take the investigational products once a day for 12 weeks. | Drug | BR1019A + BR1019B + BR1019C-1, BR1019A + BR1019B-1 + BR1019C-1, BR1019A-1 + BR1019B + BR1019C-1 |
Primary outcome
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
Time frame: 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
Time frame: 12 weeks from Baseline Visit
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
3 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing BR1019A, BR1019B and BR1019C in people with Essential Hypertension and Type 2 Diabetes Mellitus, run by Boryung Pharmaceutical Co., Ltd at 3 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 16 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in South Korea, Indonesia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Shin-young Oh (+82-2-708-8000, syoh@boryung.co.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 (time frame: 12 weeks from Baseline Visit). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Oct 2026.