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NCT Number: NCT07685054

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

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.

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Key information

Conditions

Essential Hypertension Cardiovascular Diseases Hypertension Primary Hypercholesterolemia Vascular Diseases

Age range

19 year and older

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. The proportion of patients with positive urine dipstick albuminuria

    Time frame: Week 12

Secondary outcomes

  1. Change in UACR from baseline to Weeks 12 and 24

    Time frame: Week 12, Week 24

    UACR is defined as the urine albumin-to-creatinine ratio

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

    Time frame: Week 12, Week 24

    UACR is defined as the urine albumin-to-creatinine ratio

  3. Change in UPCR from baseline to Weeks 12 and 24

    Time frame: Week 12, Week 24

    UPCR is defined as the urine protein-to-creatinine ratio

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

    Time frame: Week 12, Week 24

    UPCR is defined as the urine protein-to-creatinine ratio

  5. Change in eGFR from baseline to Weeks 12 and 24

    Time frame: Week 12, Week 24

    eGFR is defined as the estimated glomerular filtration rate

  6. Proportion of participants with a ≥50% decline in eGFR from baseline at Weeks 12 and 24

    Time frame: Week 12, Week 24

    eGFR is defined as the estimated glomerular filtration rate

  7. Change in blood pressure from baseline at Weeks 12 and 24

    Time frame: Week 12, Week 24

  8. Proportion of participants achieving the target blood pressure at Weeks 12 and 24

    Time frame: Week 12, Week 24

  9. Change in lipid profile (TC, HDL-C, TG, and LDL-C) from baseline at Weeks 12 and 24

    Time frame: Week 12, Week 24

    Lipid proflie was defined that Total cholesterol (TC); High-density lipoprotein cholesterol (HDL-C);Triglycerides (TG); Low-density lipoprotein cholesterol (LDL-C)

  10. Proportion of participants achieving the target LDL-C level at Weeks 12 and 24

    Time frame: Week 12, Week 24

  11. Proportion of participants achieving both the target blood pressure and target LDL-C level at Weeks 12 and 24

    Time frame: Week 12, Week 24

Study contacts

Contact information is provided by the study sponsor or research team.

MyungSook Hong

CONTACT

[email protected]

8227088238

Sponsors and collaborators

Lead sponsor

Boryung Pharmaceutical Co., Ltd

Industry

Registry information

Official study title

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.

Important dates

Study start
2026
Primary completion
2029
Study completion
2029
First posted
Jul 6, 2026
Registry last updated
Jul 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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