RecruitingPhase 3NCT06220773

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


Sponsor

Boryung Pharmaceutical Co., Ltd

Enrollment

276 participants

Start Date

May 21, 2024

Study Type

INTERVENTIONAL

Conditions

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


Eligibility

Min Age: 19 Years

Plain Language Summary

Simplified for easier understanding

This trial is testing a new combination treatment (BR1019A and BR1019B) that targets both type 2 diabetes and high blood pressure in patients who have both conditions. The study aims to evaluate the safety and effectiveness of this combined therapy compared to individual treatments. **You may be eligible if...** - You have both type 2 diabetes and essential (primary) high blood pressure - You are willing to stop your current blood pressure and/or diabetes medications (except metformin) during the trial, under medical supervision - Your doctor agrees this temporary change is safe for you **You may NOT be eligible if...** - You have secondary high blood pressure (caused by a specific identifiable condition) - You have symptomatic low blood pressure when standing - You have type 1 diabetes, diabetic coma, severe diabetic complications, or ketoacidosis - You have diabetic kidney disease and are taking ACE inhibitors - You have moderate to severe kidney impairment and are on renin inhibitors - You have uncontrolled severe diabetic complications affecting blood vessels, nerves, or kidneys Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGBR1019A

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

DRUGBR1019B

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

DRUGBR1019C

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

DRUGBR1019A-1

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

DRUGBR1019B-1

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

DRUGBR1019C-1

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


Locations(2)

Severance Hospital

Seoul, South Korea

Severance Hospital

Seoul, South Korea

View Full Details on ClinicalTrials.gov

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NCT06220773


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