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

Ahn-Gook Pharmaceuticals

Status: Enrolling

Conditions: Dyslipidemias; Hypercholesterolemia

Study type: Observational

Funder types: Industry

Identifiers

NCT07083206

Pitaeze_OS

Details and patient eligibility

About

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

Enrollment: 4,500 estimated patients

Sex: All

Ages: 19+ years old

Volunteers: No Healthy Volunteers

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