Observes patients with high cholesterol switching to a pitavastatin and ezetimibe tablet
Observes adults with high cholesterol moved from atorvastatin or rosuvastatin to a combined tablet.
Plain-language title generated from the registry record
Registry title: A Study to Evaluate the Effectiveness and Safety of Fixed-Dose Combination of Pitavastatin/ Ezetimibe
Key facts
- Where
- Yongin-si, South KoreaSee the site
Where in South Korea
- Yongin Severance HospitalYongin-si, South KoreaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Ahn-Gook Pharmaceuticals Co.,Ltd
- Trial code
- NCT07083206
- Record updated
- 27 October 2026
- Original description
The objective of this study is to evaluate the effectiveness and safety of Pitavastatin/Ezetimibe FDC in patients with hypercholesterolemia.Read full original descriptionShow less
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
The objective of this study is to evaluate the effectiveness and safety of Pitavastatin/Ezetimibe FDC in patients with hypercholesterolemia.
Inclusion: 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: Known hypersensitivity or history of hypersensitivity to any component of the investigational product; Patients currently receiving cyclosporine treatment; Patients with active liver disease or persistent, unexplained elevations of aminotransferase levels; Patients with severe hepatic impairment, biliary obstruction, or cholestasis; Patients with genetic disorders such as galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption; Patients diagnosed with myopathy; Pregnant or breastfeeding women, or women who may be pregnant; Any patient who, in the opinion of the investigator, is deemed unsuitable for study participation.