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

Essential Hypertension Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05930028
• Other study ID #: BR-FAEC-CT-301
• Status: Recruiting
• Phase: Phase 3
• Start date: July 13, 2023
• Est. completion date: June 2024

Study information

• Verified date: December 2023
• Source: Boryung Pharmaceutical Co., Ltd
• Contact: shinyoung Oh
• Phone: +82-2-708-8000
• Email: syoh[@]boryung.co.kr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 156
• Est. completion date: June 2024
• Est. primary completion date: June 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

<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

Related Conditions & MeSH terms

• Essential Hypertension
• Hypercholesterolemia
• Hypertension
• Primary Hypercholesterolemia

Intervention

Drug:
• Fimasartan
Subjects take the investigational products once a day for 8 weeks.
• Ezetimibe/Atorvastatin
Subjects take the investigational products once a day for 8 weeks.
• Fimasartan Placebo
Subjects take the investigational products once a day for 8 weeks.
• Ezetimibe/Atorvastatin Placebo
Subjects take the investigational products once a day for 8 weeks.

Locations

Country	Name	City	State
Korea, Republic of	Severance Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Boryung Pharmaceutical Co., Ltd

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	LDL-C	The percent of change in LDL-C from baseline in BR1017A+BR1017B at Week 8 compared to BR1017B	8weeks from Baseline Visit
Secondary	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