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

NCT07685054 | Not Yet Recruiting

• 1 other identifier: BR-FAEC-OS-401
• Study Type: observational
• Target: 12,700
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Essential Hypertension; Primary Hypercholesterolemia

Outcome Measures

Primary Outcomes (1)

• The proportion of patients with positive urine dipstick albuminuria

  Week 12

Secondary Outcomes (11)

• Change in UACR from baseline to Weeks 12 and 24

  Week 12, Week 24

• Proportion of participants achieving a ≥30% reduction in UACR from baseline at Weeks 12 and 24

  Week 12, Week 24

• Change in UPCR from baseline to Weeks 12 and 24

  Week 12, Week 24

• Proportion of participants achieving a ≥30% reduction in UPCR from baseline at Weeks 12 and 24

  Week 12, Week 24

• Change in eGFR from baseline to Weeks 12 and 24

  Week 12, Week 24

Eligibility Criteria

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

Study Population

Patients diagnosed with essential hypertension and primary hypercholesterolemia

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Boryung Pharmaceutical Co., Ltd: lead

MeSH Terms

Conditions

Essential Hypertension

Condition Hierarchy (Ancestors)

Hypertension; Vascular Diseases; Cardiovascular Diseases

Central Study Contacts

MyungSook Hong

CONTACT

8227088238; mshong@boryung.co.kr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 28, 2026
• First Posted: July 6, 2026
• Study Start: August 1, 2026
• Primary Completion (Estimated): August 15, 2029
• Study Completion (Estimated): August 15, 2029
• Last Updated: July 6, 2026

Record last verified: 2026-06