A Study to Evaluate the Effectiveness and Safety of Fixed-Dose Combination of Pitavastatin/ Ezetimibe
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age19+
SponsorAhn-Gook Pharmaceuticals Co.,Ltd
About this trial
The objective of this study is to evaluate the effectiveness and safety of Pitavastatin/Ezetimibe FDC in patients with hypercholesterolemia.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Adults aged 19 years or older
Patients diagnosed with hypercholesterolemia who have been stably treated with atorvastatin or rosuvastatin monotherapy for at least 3 months, and for whom switching to fixed-dose combination pitavastatin/ezetimibe has been clinically decided
Patients with available clinical laboratory test results related to efficacy and safety (TC, TG, HDL-C, LDL-C, AST, ALT, Cr/eGFR) within 12 months prior to switching to fixed-dose combination pitavastatin/ezetimibe (no changes in statin regimen or dosage during that period)
Individuals (or their legally authorized representatives) who voluntarily provide written informed consent to participate in the study
Disqualifiers
Known hypersensitivity or history of hypersensitivity to any component of the investigational product
Patients with active liver disease or persistent, unexplained elevations of aminotransferase levels
Patients with severe hepatic impairment, biliary obstruction, or cholestasis
Patients currently receiving cyclosporine treatment
Trial population
Patients who require administration of a fixed-dose combination of pitavastatin/ezetimibe for the treatment of 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
Rate of reaching the target LDL-C level
Time frame
12 months after administrationSponsors and contacts
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Source ClinicalTrials.gov