Essential Hypertension, Primary Hypercholesterolemia
Conditions
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.
Interventions
None listed
Sponsors
Boryung Pharmaceutical Co., Ltd
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The proportion of patients with positive urine dipstick albuminuria | Week 12 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in UACR from baseline to Weeks 12 and 24 | Week 12, Week 24 | UACR is defined as the urine albumin-to-creatinine ratio |
| Proportion of participants achieving a ≥30% reduction in UACR from baseline at Weeks 12 and 24 | Week 12, Week 24 | UACR is defined as the urine albumin-to-creatinine ratio |
| Change in UPCR from baseline to Weeks 12 and 24 | Week 12, Week 24 | UPCR is defined as the urine protein-to-creatinine ratio |
| Proportion of participants achieving a ≥30% reduction in UPCR from baseline at Weeks 12 and 24 | Week 12, Week 24 | UPCR is defined as the urine protein-to-creatinine ratio |
| Change in eGFR from baseline to Weeks 12 and 24 | Week 12, Week 24 | eGFR is defined as the estimated glomerular filtration rate |
| Proportion of participants with a ≥50% decline in eGFR from baseline at Weeks 12 and 24 | Week 12, Week 24 | eGFR is defined as the estimated glomerular filtration rate |
| Change in blood pressure from baseline at Weeks 12 and 24 | Week 12, Week 24 | — |
| Proportion of participants achieving the target blood pressure at Weeks 12 and 24 | Week 12, Week 24 | — |
| Change in lipid profile (TC, HDL-C, TG, and LDL-C) from baseline at Weeks 12 and 24 | 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) |
| Proportion of participants achieving the target LDL-C level at Weeks 12 and 24 | Week 12, Week 24 | — |
| Proportion of participants achieving both the target blood pressure and target LDL-C level at Weeks 12 and 24 | Week 12, Week 24 | — |
Contacts
CONTACTMyungSook Hong
Outcome results
None listed