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Not yet recruiting NCT07685054

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

— Observational Essential Hypertension Primary Hypercholesterolemia

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Essential Hypertension, Primary Hypercholesterolemia. Basic parameters: from 19 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

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.

Overview

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.

Primary outcome measures

  • The proportion of patients with positive urine dipstick albuminuria [Time frame: Week 12]
Secondary outcome measures (11)
  • 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]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07685054 · BR-FAEC-OS-401

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗