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

Phase 3

Recruiting

• Conditions: Essential Hypertension; Type 2 Diabetes Mellitus
• Interventions: Drug: BR1019A; Drug: BR1019C; Drug: BR1019B; Drug: BR1019A-1; Drug: BR1019B-1; Drug: BR1019C-1

• Registration Number: NCT06220773
• Lead Sponsor: Boryung Pharmaceutical Co., Ltd

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-01-14
• Study First Submitted QC: 2024-01-14
• Study First Posted: 2024-01-24
• Status Verified: 2024-05
• Study Start: 2024-05-21
• Last Update Submitted: 2024-05-21
• Last Update Posted: 2024-05-22
• Primary Completion: 2025-04
• Study Completion: 2025-04

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 276

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
BR1019A + BR1019B + BR1019C-1	BR1019C-1	-
BR1019A-1 + BR1019B + BR1019C	BR1019C	-
BR1019A + BR1019B + BR1019C-1	BR1019B	-
BR1019A-1 + BR1019B + BR1019C-1	BR1019A-1	-
BR1019A-1 + BR1019B + BR1019C	BR1019A-1	-
BR1019A-1 + BR1019B + BR1019C	BR1019B	-
BR1019A + BR1019B-1 + BR1019C-1	BR1019C-1	-
BR1019A-1 + BR1019B + BR1019C-1	BR1019B	-
BR1019A-1 + BR1019B + BR1019C-1	BR1019C-1	-
BR1019A + BR1019B + BR1019C-1	BR1019A	-
BR1019A + BR1019B-1 + BR1019C-1	BR1019B-1	-
BR1019A + BR1019B-1 + BR1019C-1	BR1019A	-

Primary Outcome Measures

Name	Time	Method
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
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

Trial Locations

Locations (1)

Severance Hospital; 🇰🇷 Seoul, Korea, Republic of