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
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