Essential HypertensionNCT07685054
To Evaluate the Renal Protective Effects and Safety of 'Fimasartan and Atorvastatin' or 'Fimasartan, Atorvastatin and Ezetimibe'.
An observational study of Essential Hypertension and Primary Hypercholesterolemia, run by Boryung Pharmaceutical Co., Ltd.
Trial 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. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Essential Hypertension, Primary Hypercholesterolemia
- How many people
- 12,700 participants
- Where
- No sites listed yet
- Study dates
- 1 Aug 2026to 15 Aug 2029
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients diagnosed with essential hypertension and primary hypercholesterolemia
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official 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.
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.
- Medical subject headings
- Essential Hypertension
What is being measured
The primary outcome is the main question the study is designed to answer.
The proportion of patients with positive urine dipstick albuminuria
Measured: Week 12
Secondary outcomes (11)
Change in UACR from baseline to Weeks 12 and 24
UACR is defined as the urine albumin-to-creatinine ratio
Measured: 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
Measured: Week 12, Week 24
Change in UPCR from baseline to Weeks 12 and 24
UPCR is defined as the urine protein-to-creatinine ratio
Measured: 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
Measured: Week 12, Week 24
Change in eGFR from baseline to Weeks 12 and 24
eGFR is defined as the estimated glomerular filtration rate
Measured: 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
Measured: Week 12, Week 24
Change in blood pressure from baseline at Weeks 12 and 24
Measured: Week 12, Week 24
Proportion of participants achieving the target blood pressure at Weeks 12 and 24
Measured: 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)
Measured: Week 12, Week 24
Proportion of participants achieving the target LDL-C level at Weeks 12 and 24
Measured: Week 12, Week 24
Proportion of participants achieving both the target blood pressure and target LDL-C level at Weeks 12 and 24
Measured: Week 12, Week 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jul 2026
- Study start1 Aug 2026 (estimated)
- Primary completion15 Aug 2029 (estimated)
- Study completion15 Aug 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Essential HypertensionStudies of the same condition, open and under way.
- More trials run by Boryung Pharmaceutical Co., LtdThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 12,700 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Boryung Pharmaceutical Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07685054
- Sponsor's protocol ID
- BR-FAEC-OS-401
- Status last verified
- Jun 2026
- First submitted
- 28 Jun 2026
- Last updated
- 6 Jul 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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.
- ClinicalTrials.gov ID
- NCT07685054
- Acronym / sponsor ID
- BR-FAEC-OS-401
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 12,700 participants (estimated)
- Lead sponsor
- Boryung Pharmaceutical Co., LtdIndustry (pharma, biotech, devices)
- Study start
- 1 Aug 2026 (estimated)
- Primary completion
- 15 Aug 2029 (estimated)
- Study completion
- 15 Aug 2029 (estimated)
- First posted
- 6 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients diagnosed with essential hypertension and primary hypercholesterolemia
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
The proportion of patients with positive urine dipstick albuminuria
Time frame: Week 12
11 secondary outcomes
Change in UACR from baseline to Weeks 12 and 24
Time frame: Week 12, Week 24
Proportion of participants achieving a ≥30% reduction in UACR from baseline at Weeks 12 and 24
Time frame: Week 12, Week 24
Change in UPCR from baseline to Weeks 12 and 24
Time frame: Week 12, Week 24
Proportion of participants achieving a ≥30% reduction in UPCR from baseline at Weeks 12 and 24
Time frame: Week 12, Week 24
Change in eGFR from baseline to Weeks 12 and 24
Time frame: Week 12, Week 24
Proportion of participants with a ≥50% decline in eGFR from baseline at Weeks 12 and 24
Time frame: Week 12, Week 24
Change in blood pressure from baseline at Weeks 12 and 24
Time frame: Week 12, Week 24
Proportion of participants achieving the target blood pressure at Weeks 12 and 24
Time frame: Week 12, Week 24
Change in lipid profile (TC, HDL-C, TG, and LDL-C) from baseline at Weeks 12 and 24
Time frame: Week 12, Week 24
Proportion of participants achieving the target LDL-C level at Weeks 12 and 24
Time frame: Week 12, Week 24
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jul 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
An observational study of Essential Hypertension and Primary Hypercholesterolemia, run by Boryung Pharmaceutical Co., Ltd.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 6 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact MyungSook Hong (8227088238, mshong@boryung.co.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The proportion of patients with positive urine dipstick albuminuria (time frame: Week 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jul 2026.