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

NCT05930028 | Completed Phase 3

• 1 other identifier: BR-FAEC-CT-301
• Study Type: interventional
• Target: 148
• Locations: 1 country
• Sites: 1

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

Conditions

Essential Hypertension; Primary Hypercholesterolemia

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• LDL-C

  8weeks from Baseline Visit

• Mean sitting systolic blood pressure

  8weeks from Baseline Visit

Study Arms (3)

Fimasartan/Ezetimibe/Atorvastatin

EXPERIMENTAL

BR1017A+BR1017B(Experimental Group)

Drug: Fimasartan; Drug: Ezetimibe/Atorvastatin

Fimasartan

ACTIVE COMPARATOR

BR1017A(Control Group 2)

Drug: Fimasartan; Drug: Ezetimibe/Atorvastatin Placebo

Ezetimibe/Atorvastatin

ACTIVE COMPARATOR

BR1017B(Control Group 1)

Drug: Ezetimibe/Atorvastatin; Drug: Fimasartan Placebo

Interventions

Fimasartan DRUG

Subjects take the investigational products once a day for 8 weeks.

Also known as: BR1017A

Fimasartan; Fimasartan/Ezetimibe/Atorvastatin

Ezetimibe/Atorvastatin DRUG

Subjects take the investigational products once a day for 8 weeks.

Also known as: BR1017B

Ezetimibe/Atorvastatin; Fimasartan/Ezetimibe/Atorvastatin

Fimasartan Placebo DRUG

Subjects take the investigational products once a day for 8 weeks.

Also known as: BR1017A-1

Ezetimibe/Atorvastatin

Ezetimibe/Atorvastatin Placebo DRUG

Subjects take the investigational products once a day for 8 weeks.

Also known as: BR1017B-1

Fimasartan

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)
• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Boryung Pharmaceutical Co., Ltd: lead

Study Sites (1)

Severance Hospital

Seoul, 120-752, South Korea

Location

MeSH Terms

Conditions

Essential Hypertension

Interventions

fimasartan; Ezetimibe; Atorvastatin

Condition Hierarchy (Ancestors)

Hypertension; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Azetidines; Azetines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Pyrroles; Azoles; Heptanoic Acids; Fatty Acids; Lipids

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 26, 2023
• First Posted: July 5, 2023
• Study Start: July 13, 2023
• Primary Completion: September 5, 2024
• Study Completion: September 5, 2024
• Last Updated: October 18, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)