ClinicalTrials.gg
Not yet recruitingNCT07685054Updated Jul 6, 2026

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

An observational study in Essential Hypertension and Primary Hypercholesterolemia, sponsored by Boryung Pharmaceutical Co., Ltd. Not yet recruiting. Open to participants aged 19 Years and older. Per ClinicalTrials.gov, last updated 2026-07-06.

Sponsored by Boryung Pharmaceutical Co., Ltd · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
12,700
Ages
19 Years and older
Sex
All
01

Study 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.

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Conditions studied

  • Essential Hypertension
  • Primary Hypercholesterolemia
03

In context

Essential Hypertension

478 studies on the registry are indexed under Essential Hypertension; 74 are open to participants now.

This study's planned enrollment of 12,700 is above the median of 702 across 70 observational studies indexed under Essential Hypertension.

Browse Essential Hypertension studies →

Lead sponsor

Boryung Pharmaceutical Co., Ltd is the lead sponsor of 143 studies on the registry; 23 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
19 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Patients diagnosed with essential hypertension and primary hypercholesterolemia

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion Criteria:

  • Patients who received concomitant administration of fimasartan and atorvastatin within 4 weeks prior to baseline.
  • Patients with any to fimasartan, atorvastatin, or ezetimibe as specified in the approved product labeling.
  • Patients who have received 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.
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

Investigational drug or device

A drug or device being studied in a clinical trial.

It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.

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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
12,700 participants (estimated)
Patient registry
No
06

What researchers measure

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

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

    Time frame: Week 12, Week 24

  2. 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

    Time frame: Week 12, Week 24

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

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

    Time frame: Week 12, Week 24

  4. 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

    Time frame: Week 12, Week 24

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

    eGFR is defined as the estimated glomerular filtration rate

    Time frame: Week 12, Week 24

  6. 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

    Time frame: Week 12, Week 24

  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

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

    Time frame: Week 12, Week 24

  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

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Study locations

No study locations are listed for this record.

08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 6, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT07685054
Responsible party
Sponsor
First posted
Jul 6, 2026
Start date
Aug 1, 2026 (estimated)
Primary completion
Aug 15, 2029 (estimated)
Completion
Aug 15, 2029 (estimated)
Last update
Jul 6, 2026

Study contacts

MyungSook Hong
Contact
mshong@boryung.co.kr
8227088238

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Jun 2026. You cannot join it, but the record below documents what was studied.

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Discussion

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