To Evaluate the Renal Protective Effects and Safety of 'Fimasartan and Atorvastatin' or 'Fimasartan, Atorvastatin and Ezetimibe'.

A Multicenter, Prospective Observational Study to Evaluate the Renal Protective Effects and Safety of 'Fimasartan and Atorvastatin' or 'Fimasartan, Atorvastatin and Ezetimibe' in Patients With Essential Hypertension and Primary Hypercholesterolemia.

This prospective study aims to observe changes in renal function and related parameters in patients with essential hypertension and primary hypercholesterolemia receiving either the combination of fimasartan and atorvastatin or the combination of fimasartan, atorvastatin, and ezetimibe.

Study Overview

• Status: Not yet recruiting
• Conditions: Essential Hypertension; Primary Hypercholesterolemia

• Study Type: Observational
• Enrollment (Estimated): 12700

Contacts and Locations

• Study Contact: Name: MyungSook Hong; Phone Number: 8227088238; Email: mshong@boryung.co.kr

Participation Criteria

Eligibility Criteria

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

• Sampling Method: Non-Probability Sample

Study Population

Patients diagnosed with essential hypertension and primary hypercholesterolemia

Description

Inclusion Criteria:

• Those who are briefed about the clinical trial objectives and methods, and express their consent to participate in the trial by signing a written consent on the use of their personal information.
• Patients diagnosed with essential hypertension and primary hypercholesterolemia.
• Patients scheduled to receive either fimasartan plus atorvastatin or fimasartan plus atorvastatin plus ezetimibe.

Exclusion Criteria:

• Patients who received concomitant administration of fimasartan and atorvastatin within 4 weeks prior to baseline.
• Patients with any contraindication to fimasartan, atorvastatin, or ezetimibe as specified in the approved product labeling.
• Patients who have received investigational or study drugs from another clinical trial or research study within 12 weeks prior to baseline. However, participation in non-interventional observational studies is permitted.
• Patients considered unsuitable for study participation at the discretion of the principal investigator or sub-investigator.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
The proportion of patients with positive urine dipstick albuminuria	Week 12

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in UACR from baseline to Weeks 12 and 24	UACR is defined as the urine albumin-to-creatinine ratio	Week 12, Week 24
Proportion of participants achieving a ≥30% reduction in UACR from baseline at Weeks 12 and 24	UACR is defined as the urine albumin-to-creatinine ratio	Week 12, Week 24
Change in UPCR from baseline to Weeks 12 and 24	UPCR is defined as the urine protein-to-creatinine ratio	Week 12, Week 24
Proportion of participants achieving a ≥30% reduction in UPCR from baseline at Weeks 12 and 24	UPCR is defined as the urine protein-to-creatinine ratio	Week 12, Week 24
Change in eGFR from baseline to Weeks 12 and 24	eGFR is defined as the estimated glomerular filtration rate	Week 12, Week 24
Proportion of participants with a ≥50% decline in eGFR from baseline at Weeks 12 and 24	eGFR is defined as the estimated glomerular filtration rate	Week 12, Week 24
Change in blood pressure from baseline at Weeks 12 and 24		Week 12, Week 24
Proportion of participants achieving the target blood pressure at Weeks 12 and 24		Week 12, Week 24
Change in lipid profile (TC, HDL-C, TG, and LDL-C) from baseline at Weeks 12 and 24	Lipid proflie was defined that Total cholesterol (TC); High-density lipoprotein cholesterol (HDL-C);Triglycerides (TG); Low-density lipoprotein cholesterol (LDL-C)	Week 12, Week 24
Proportion of participants achieving the target LDL-C level at Weeks 12 and 24		Week 12, Week 24
Proportion of participants achieving both the target blood pressure and target LDL-C level at Weeks 12 and 24		Week 12, Week 24

Collaborators and Investigators

• Sponsor: Boryung Pharmaceutical Co., Ltd

Study record dates

Study Major Dates

• Study Start (Estimated): August 1, 2026
• Primary Completion (Estimated): August 15, 2029
• Study Completion (Estimated): August 15, 2029

Study Registration Dates

• First Submitted: June 28, 2026
• First Submitted That Met QC Criteria: June 28, 2026
• First Posted (Actual): July 6, 2026

Study Record Updates

• Last Update Posted (Actual): July 6, 2026
• Last Update Submitted That Met QC Criteria: June 28, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Hypertension; Essential Hypertension
• Other Study ID Numbers: BR-FAEC-OS-401

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No