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

Phase 3

Completed

• Conditions: Essential Hypertension; Primary Hypercholesterolemia
• Interventions: Drug: Fimasartan; Drug: Ezetimibe/Atorvastatin; Drug: Ezetimibe/Atorvastatin Placebo; Drug: Fimasartan Placebo

• Registration Number: NCT05930028
• Lead Sponsor: Boryung Pharmaceutical Co., Ltd

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-06-26
• Study First Submitted QC: 2023-06-26
• Study First Posted: 2023-07-05
• Study Start: 2023-07-13
• Primary Completion: 2024-09-05
• Study Completion: 2024-09-05
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-17
• Last Update Posted: 2024-10-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 148

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Fimasartan/Ezetimibe/Atorvastatin	Ezetimibe/Atorvastatin	BR1017A+BR1017B(Experimental Group)
Fimasartan	Ezetimibe/Atorvastatin Placebo	BR1017A(Control Group 2)
Ezetimibe/Atorvastatin	Ezetimibe/Atorvastatin	BR1017B(Control Group 1)
Ezetimibe/Atorvastatin	Fimasartan Placebo	BR1017B(Control Group 1)
Fimasartan	Fimasartan	BR1017A(Control Group 2)
Fimasartan/Ezetimibe/Atorvastatin	Fimasartan	BR1017A+BR1017B(Experimental Group)

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Severance Hospital; 🇰🇷 Seoul, Korea, Republic of