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A Study to Evaluate the Efficacy and Safety of BR1017A and BR1017B Combination Therapy in Essential Hypertension Patients With Primary Hypercholesterolemia

Primary Purpose

Essential Hypertension, Primary Hypercholesterolemia

Status
Recruiting
Phase
Phase 3
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Fimasartan
Ezetimibe/Atorvastatin
Fimasartan Placebo
Ezetimibe/Atorvastatin Placebo
Sponsored by
Boryung Pharmaceutical Co., Ltd
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Essential Hypertension

Eligibility Criteria

19 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

<Inclusion Criteria> Screening Patients with essential hypertension and primary hypercholesterolemia If patients are being treated with antihypertensive/antihyperlipidemic drugs at screening (V1), they should be determined to be medically reasonable by investigator about discontinuing existing antihypertensive/antihyperlipidemic drugs during the clinical trial Patients who have an fasting triglyceride (TG) < 400 mg/dL and LDL-C ≤ 250 mg/dL at Screening (V1) Voluntarily provided a written consent to participate in this clinical study Able to understand this study, be cooperative in the execution of the study, and participate in the study until its completion Randomization Patients who meet the following criteria of blood pressure measured in selected reference arm before randomization at baseline(V3) 140 mmHg ≤ MSSBP < 180 mmHg MSDBP < 110 mmHg Patients who meet the criteria of fasting serum lipid levels and risk factors at pre-baseline (V2) after undergoing the therapeutic lifestyle change (TLC) Patients who have an fasting triglyceride (TG) < 400 mg/dL and LDL-C ≤ 250 mg/dL after undergoing the therapeutic lifestyle change (TLC) for at least 4 weeks before pre-baseline (V2) <Exclusion Criteria> Patients with blood pressure results showing MSSBP ≥ 180 mmHg or MSDBP ≥ 110 mmHg in the selected reference arm at screening(V1) or Baseline(V3) Patients with a difference of MSSBP ≥ 20 mmHg and MSDBP ≥ 10 mmHg in blood pressure measured three times on both arms at screening(V1) Patients with past history and comorbidities at screening(V1) under the following criteria: Patients with secondary hypertension: Secondary hypertension is not limited to the following diseases; (e.g., coarctation of the aorta, hyperaldosteronism, renal artery stenosis, Cushing's syndrome, pheochromocytoma and polycystic kidney disease, etc.) Patients with secondary hyperlipidemia: Secondary hyperlipidemia is not limited to the following diseases; (e.g., Chronic renal failure, nephrotic syndrome, obstructive liver disease, hypothyroidism, dysproteinemia, etc.) Patients with orthostatic hypotension accompanied by symptoms

Sites / Locations

  • Severance HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Active Comparator

Arm Label

Fimasartan/Ezetimibe/Atorvastatin

Fimasartan

Ezetimibe/Atorvastatin

Arm Description

BR1017A+BR1017B(Experimental Group)

BR1017A(Control Group 2)

BR1017B(Control Group 1)

Outcomes

Primary Outcome Measures

Mean sitting systolic blood pressure
The change of mean sitting systolic blood pressure from baseline in BR1017A+BR1017B at Week 8 compared to BR1017B
LDL-C
The percent of change in LDL-C from baseline in BR1017A+BR1017B at Week 8 compared to BR1017A

Secondary Outcome Measures

LDL-C
The percent of change in LDL-C from baseline in BR1017A+BR1017B at Week 8 compared to BR1017B
Mean sitting systolic blood pressure
The change of mean sitting systolic blood pressure from baseline in BR1017A+BR1017B at Week 8 compared to BR1017A

Full Information

First Posted
June 26, 2023
Last Updated
July 16, 2023
Sponsor
Boryung Pharmaceutical Co., Ltd
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1. Study Identification

Unique Protocol Identification Number
NCT05930028
Brief Title
A Study to Evaluate the Efficacy and Safety of BR1017A and BR1017B Combination Therapy in Essential Hypertension Patients With Primary Hypercholesterolemia
Official Title
A Randomized, Double-blind, Multi-center, Phase III Trial to Evaluate the Efficacy and Safety of BR1017A and BR1017B Combination Therapy in Essential Hypertension Patients With Primary Hypercholesterolemia
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 13, 2023 (Actual)
Primary Completion Date
June 2024 (Anticipated)
Study Completion Date
June 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Boryung Pharmaceutical Co., Ltd

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The objective of this clinical study is to evaluate the efficacy and safety by comparing BR1017A+BR1017B treatment group to BR1017A treatment group and BR1017B treatment group respectively at Week 8 in essential hypertension patients with primary hypercholesterolemia

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Essential Hypertension, Primary Hypercholesterolemia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
150 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Fimasartan/Ezetimibe/Atorvastatin
Arm Type
Experimental
Arm Description
BR1017A+BR1017B(Experimental Group)
Arm Title
Fimasartan
Arm Type
Active Comparator
Arm Description
BR1017A(Control Group 2)
Arm Title
Ezetimibe/Atorvastatin
Arm Type
Active Comparator
Arm Description
BR1017B(Control Group 1)
Intervention Type
Drug
Intervention Name(s)
Fimasartan
Other Intervention Name(s)
BR1017A
Intervention Description
Subjects take the investigational products once a day for 8 weeks.
Intervention Type
Drug
Intervention Name(s)
Ezetimibe/Atorvastatin
Other Intervention Name(s)
BR1017B
Intervention Description
Subjects take the investigational products once a day for 8 weeks.
Intervention Type
Drug
Intervention Name(s)
Fimasartan Placebo
Other Intervention Name(s)
BR1017A-1
Intervention Description
Subjects take the investigational products once a day for 8 weeks.
Intervention Type
Drug
Intervention Name(s)
Ezetimibe/Atorvastatin Placebo
Other Intervention Name(s)
BR1017B-1
Intervention Description
Subjects take the investigational products once a day for 8 weeks.
Primary Outcome Measure Information:
Title
Mean sitting systolic blood pressure
Description
The change of mean sitting systolic blood pressure from baseline in BR1017A+BR1017B at Week 8 compared to BR1017B
Time Frame
8weeks from Baseline Visit
Title
LDL-C
Description
The percent of change in LDL-C from baseline in BR1017A+BR1017B at Week 8 compared to BR1017A
Time Frame
8weeks from Baseline Visit
Secondary Outcome Measure Information:
Title
LDL-C
Description
The percent of change in LDL-C from baseline in BR1017A+BR1017B at Week 8 compared to BR1017B
Time Frame
8weeks from Baseline Visit
Title
Mean sitting systolic blood pressure
Description
The change of mean sitting systolic blood pressure from baseline in BR1017A+BR1017B at Week 8 compared to BR1017A
Time Frame
8weeks from Baseline Visit

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
<Inclusion Criteria> Screening Patients with essential hypertension and primary hypercholesterolemia If patients are being treated with antihypertensive/antihyperlipidemic drugs at screening (V1), they should be determined to be medically reasonable by investigator about discontinuing existing antihypertensive/antihyperlipidemic drugs during the clinical trial Patients who have an fasting triglyceride (TG) < 400 mg/dL and LDL-C ≤ 250 mg/dL at Screening (V1) Voluntarily provided a written consent to participate in this clinical study Able to understand this study, be cooperative in the execution of the study, and participate in the study until its completion Randomization Patients who meet the following criteria of blood pressure measured in selected reference arm before randomization at baseline(V3) 140 mmHg ≤ MSSBP < 180 mmHg MSDBP < 110 mmHg Patients who meet the criteria of fasting serum lipid levels and risk factors at pre-baseline (V2) after undergoing the therapeutic lifestyle change (TLC) Patients who have an fasting triglyceride (TG) < 400 mg/dL and LDL-C ≤ 250 mg/dL after undergoing the therapeutic lifestyle change (TLC) for at least 4 weeks before pre-baseline (V2) <Exclusion Criteria> Patients with blood pressure results showing MSSBP ≥ 180 mmHg or MSDBP ≥ 110 mmHg in the selected reference arm at screening(V1) or Baseline(V3) Patients with a difference of MSSBP ≥ 20 mmHg and MSDBP ≥ 10 mmHg in blood pressure measured three times on both arms at screening(V1) Patients with past history and comorbidities at screening(V1) under the following criteria: Patients with secondary hypertension: Secondary hypertension is not limited to the following diseases; (e.g., coarctation of the aorta, hyperaldosteronism, renal artery stenosis, Cushing's syndrome, pheochromocytoma and polycystic kidney disease, etc.) Patients with secondary hyperlipidemia: Secondary hyperlipidemia is not limited to the following diseases; (e.g., Chronic renal failure, nephrotic syndrome, obstructive liver disease, hypothyroidism, dysproteinemia, etc.) Patients with orthostatic hypotension accompanied by symptoms
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
shinyoung Oh
Phone
+82-2-708-8000
Email
syoh@boryung.co.kr
Facility Information:
Facility Name
Severance Hospital
City
Seoul
ZIP/Postal Code
120-752
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jong Won Ha

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

A Study to Evaluate the Efficacy and Safety of BR1017A and BR1017B Combination Therapy in Essential Hypertension Patients With Primary Hypercholesterolemia

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