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
| Registry | NCT07083206, acronym PIVOTAL |
|---|---|
| Status | Recruiting |
| Study type | Observational |
| Enrollment | 4500 (Estimated) |
| Sponsor | Ahn-Gook Pharmaceuticals Co.,Ltd (Industry) |
| Conditions | Hypercholesterolemia, Dyslipidemias |
| Dates | start 2025-07-29, primary completion 2028-07-01 (estimated), completion 2029-01-01 (estimated), first posted 2025-07-24, last updated 2025-08-07 |
| Locations | 1 site in South Korea |
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The objective of this study is to evaluate the effectiveness and safety of Pitavastatin/Ezetimibe FDC in patients with hypercholesterolemia.
Sex: All, ages: 19 Years to any
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
| Facility | City | Country | Status |
|---|---|---|---|
| Yongin Severance Hospital | Yongin-si | South Korea | Recruiting |