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

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

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

Study Overview

• Status: Completed
• Conditions: Essential Hypertension; Primary Hypercholesterolemia
• Intervention / Treatment: Drug: Fimasartan; Drug: Ezetimibe/Atorvastatin; Drug: Ezetimibe/Atorvastatin Placebo; Drug: Fimasartan Placebo

• Study Type: Interventional
• Enrollment (Actual): 148
• Phase: Phase 3

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of, 120-752
    • Severance Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

<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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Fimasartan/Ezetimibe/Atorvastatin; BR1017A+BR1017B(Experimental Group)	Drug: Fimasartan; Subjects take the investigational products once a day for 8 weeks.; Other Names: BR1017A; Drug: Ezetimibe/Atorvastatin; Subjects take the investigational products once a day for 8 weeks.; Other Names: BR1017B
Active Comparator: Fimasartan; BR1017A(Control Group 2)	Drug: Fimasartan; Subjects take the investigational products once a day for 8 weeks.; Other Names: BR1017A; Drug: Ezetimibe/Atorvastatin Placebo; Subjects take the investigational products once a day for 8 weeks.; Other Names: BR1017B-1
Active Comparator: Ezetimibe/Atorvastatin; BR1017B(Control Group 1)	Drug: Ezetimibe/Atorvastatin; Subjects take the investigational products once a day for 8 weeks.; Other Names: BR1017B; Drug: Fimasartan Placebo; Subjects take the investigational products once a day for 8 weeks.; Other Names: BR1017A-1

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean sitting systolic blood pressure	The change of mean sitting systolic blood pressure from baseline in BR1017A+BR1017B at Week 8 compared to BR1017B	8weeks from Baseline Visit
LDL-C	The percent of change in LDL-C from baseline in BR1017A+BR1017B at Week 8 compared to BR1017A	8weeks from Baseline Visit

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
LDL-C	The percent of change in LDL-C from baseline in BR1017A+BR1017B at Week 8 compared to BR1017B	8weeks from Baseline Visit
Mean sitting systolic blood pressure	The change of mean sitting systolic blood pressure from baseline in BR1017A+BR1017B at Week 8 compared to BR1017A	8weeks from Baseline Visit

Collaborators and Investigators

• Sponsor: Boryung Pharmaceutical Co., Ltd

Study record dates

Study Major Dates

• Study Start (Actual): July 13, 2023
• Primary Completion (Actual): September 5, 2024
• Study Completion (Actual): September 5, 2024

Study Registration Dates

• First Submitted: June 26, 2023
• First Submitted That Met QC Criteria: June 26, 2023
• First Posted (Actual): July 5, 2023

Study Record Updates

• Last Update Posted (Actual): October 18, 2024
• Last Update Submitted That Met QC Criteria: October 17, 2024
• Last Verified: October 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Metabolic Diseases; Lipid Metabolism Disorders; Hyperlipidemias; Dyslipidemias; Hypertension; Hypercholesterolemia; Essential Hypertension; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antimetabolites; Anticholesteremic Agents; Hypolipidemic Agents; Lipid Regulating Agents; Hydroxymethylglutaryl-CoA Reductase Inhibitors; Atorvastatin; Ezetimibe
• Other Study ID Numbers: BR-FAEC-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