A Study to Evaluate the Efficacy and Safety of BR1019A and BR1019B Combination Therapy

NCT06220773 | Recruiting Phase 3

• 1 other identifier: BR-FDC-CT-301
• Study Type: interventional
• Target: 276
• Locations: 1 country
• Sites: 2

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

Conditions

Essential Hypertension; Type 2 Diabetes Mellitus

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (4)

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

Interventions

BR1019A DRUG

Subjects take the investigational products once a day for 12 weeks.

BR1019A + BR1019B + BR1019C-1; BR1019A + BR1019B-1 + BR1019C-1

BR1019B DRUG

Subjects take the investigational products once a day for 12 weeks.

BR1019A + BR1019B + BR1019C-1; BR1019A-1 + BR1019B + BR1019C; BR1019A-1 + BR1019B + BR1019C-1

BR1019C DRUG

Subjects take the investigational products once a day for 12 weeks.

BR1019A-1 + BR1019B + BR1019C

BR1019A-1 DRUG

Subjects take the investigational products once a day for 12 weeks.

BR1019A-1 + BR1019B + BR1019C; BR1019A-1 + BR1019B + BR1019C-1

BR1019B-1 DRUG

Subjects take the investigational products once a day for 12 weeks.

BR1019A + BR1019B-1 + BR1019C-1

BR1019C-1 DRUG

Subjects take the investigational products once a day for 12 weeks.

BR1019A + BR1019B + BR1019C-1; BR1019A + BR1019B-1 + BR1019C-1; BR1019A-1 + BR1019B + BR1019C-1

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Boryung Pharmaceutical Co., Ltd: lead

Study Sites (2)

Severance Hospital

Seoul, South Korea

RECRUITING

Severance Hospital

Seoul, South Korea

RECRUITING

MeSH Terms

Conditions

Essential Hypertension; Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Hypertension; Vascular Diseases; Cardiovascular Diseases; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Central Study Contacts

Shin-young Oh

CONTACT

+82-2-708-8000; syoh@boryung.co.kr

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 14, 2024
• First Posted: January 24, 2024
• Study Start: May 21, 2024
• Primary Completion: April 1, 2025
• Study Completion: April 1, 2025
• Last Updated: May 22, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

KR (2)