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

Recruiting · NCT07083206 · Observational (researchers observe without assigning treatment) · Lead sponsor: Ahn-Gook Pharmaceuticals Co.,Ltd

What this trial is about

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

Age range

19 Years and older

Sex

All (male and female)

Healthy volunteers

No - a diagnosis or condition is required

Phase

Not specified

Study type

Observational (researchers observe without assigning treatment)

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

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

1 location listed.