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

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age19+
SponsorBoryung Pharmaceutical Co., Ltd

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 volunteers

Qualifiers

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

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

No trial groups listed

Trial outcomes

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

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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This trial is not recruiting at the moment. You can still explore other options: