About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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 population
Patients diagnosed with essential hypertension and primary hypercholesterolemia
Trial design
Cohort
Prospective
Treatments tested in this trial
Not listed
Trial groups
Trial outcomes
Primary outcomes
The proportion of patients with positive urine dipstick albuminuria
Secondary outcomes
Change in UACR from baseline to Weeks 12 and 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
UACR is defined as the urine albumin-to-creatinine ratio
Change in UPCR from baseline to Weeks 12 and 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
UPCR is defined as the urine protein-to-creatinine ratio
Locations
Sponsors and contacts
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This trial is not recruiting at the moment. You can still explore other options: