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

May 21, 2024 updated by: Boryung Pharmaceutical Co., Ltd

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

276

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Korea, Republic of
      • Seoul, Korea, Republic of
        • Recruiting
        • Severance Hospital
        • Contact:
          • Bong-Soo Cha, M.D., Ph.D.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: BR1019A + BR1019B + BR1019C-1
Drug: BR1019A
Subjects take the investigational products once a day for 12 weeks.
Drug: BR1019B
Subjects take the investigational products once a day for 12 weeks.
Drug: BR1019C-1
Subjects take the investigational products once a day for 12 weeks.
Active Comparator: BR1019A + BR1019B-1 + BR1019C-1
Drug: BR1019A
Subjects take the investigational products once a day for 12 weeks.
Drug: BR1019C-1
Subjects take the investigational products once a day for 12 weeks.
Drug: BR1019B-1
Subjects take the investigational products once a day for 12 weeks.
Active Comparator: BR1019A-1 + BR1019B + BR1019C-1
Drug: BR1019B
Subjects take the investigational products once a day for 12 weeks.
Drug: BR1019C-1
Subjects take the investigational products once a day for 12 weeks.
Drug: BR1019A-1
Subjects take the investigational products once a day for 12 weeks.
Other: BR1019A-1 + BR1019B + BR1019C
Drug: BR1019B
Subjects take the investigational products once a day for 12 weeks.
Drug: BR1019A-1
Subjects take the investigational products once a day for 12 weeks.
Drug: BR1019C
Subjects take the investigational products once a day for 12 weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
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
12 weeks from Baseline Visit

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Boryung Pharmaceutical Co., Ltd

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 21, 2024

Primary Completion (Estimated)

April 1, 2025

Study Completion (Estimated)

April 1, 2025

Study Registration Dates

First Submitted

January 14, 2024

First Submitted That Met QC Criteria

January 14, 2024

First Posted (Actual)

January 24, 2024

Study Record Updates

Last Update Posted (Actual)

May 22, 2024

Last Update Submitted That Met QC Criteria

May 21, 2024

Last Verified

May 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BR-FDC-CT-301

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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