Skip to main content
TrialFinder
TrialFinder is for informational purposes only and does not provide medical advice. Always talk to your doctor about whether a trial is right for you.
RECRUITINGOBSERVATIONAL

A Study to Evaluate the Effectiveness and Safety of Fixed-Dose Combination of Pitavastatin/ Ezetimibe

A Multi-center, Prospective, Non-intervention, Observational Study to Evaluate the Effectiveness and Safety of Switching to Pevarozet Tablet in Patients With Hypercholesterolemia Previously Treated With Atorvastatin or Rosuvastatin Monotherapy

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

The objective of this study is to evaluate the effectiveness and safety of Pitavastatin/Ezetimibe FDC in patients with hypercholesterolemia.

Who May Be Eligible (Plain English)

Who May Qualify: - 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 willing to sign a consent form to participate in the study Who Should NOT Join This Trial: - 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 - Patients diagnosed with myopathy - Pregnant or breastfeeding women, or women who may be pregnant - Patients with genetic disorders such as galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption - Any patient who, in the opinion of the investigator, is deemed unsuitable for study participation Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
Inclusion Criteria: * 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 Exclusion Criteria: * 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 * Patients diagnosed with myopathy * Pregnant or breastfeeding women, or women who may be pregnant * Patients with genetic disorders such as galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption * Any patient who, in the opinion of the investigator, is deemed unsuitable for study participation

Locations (1)

Yongin Severance Hospital
Yongin-si, South Korea