Actively Recruiting

Phase 3
Age: 19Years +
All Genders
NCT06220773

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

Led by Boryung Pharmaceutical Co., Ltd · Updated on 2024-05-22

276

Participants Needed

2

Research Sites

45 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Official Title

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

Who Can Participate

Age: 19Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Have both type 2 diabetes mellitus and essential hypertension
  • Agree to stop current antihypertensive and/or oral diabetes medications during the study
  • Medically able to discontinue current antihypertensive and/or oral diabetes medications except Metformin during the study
Not Eligible

You will not qualify if you...

  • History or suspicion of secondary hypertension including conditions like renovascular disease, adrenal hyperfunctions, aortic coarctation, primary hyperaldosteronism, renal artery stenosis, Cushing's syndrome, pheochromocytoma, or polycystic kidney disease
  • Presence of clinically significant orthostatic hypotension with symptoms
  • Diabetes patients taking renin inhibitors (Aliskiren) or with moderate to severe kidney impairment
  • Diabetic nephropathy patients taking ACE inhibitors
  • Type 1 diabetes, secondary diabetes, severe insulin-dependent diabetes, diabetic ketoacidosis, or lactic acidosis
  • Uncontrolled or severe diabetic complications including microvascular or macrovascular issues
  • History of diabetic coma or pre-coma

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

1
2
3
+1

Trial Site Locations

Total: 2 locations

1

Severance Hospital

Seoul, South Korea

Actively Recruiting

2

Severance Hospital

Seoul, South Korea

Actively Recruiting

Loading map...

Research Team

S

Shin-young Oh

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

4

Not the Right Trial for You?

Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.

Already have an account? Log in here