A Multicenter, Prospective, Cohort Study to Evaluate the Efficacy and Safety of Fixed-Dose Combination of Pitavastatin/Ezetimibe Under the Real-World Condition

What this Trial Is About

Researchers are evaluating the effectiveness and safety of a fixed-dose combination of Pitavastatin and Ezetimibe in people with primary hypercholesterolemia or mixed dyslipidemia. This observational study is conducted under real-world conditions to better understand how this combination works outside of typical clinical trial settings. It is sponsored by Boryung Pharmaceutical Co., Ltd and focuses on patients who need changes in their statin treatment or additional cholesterol-lowering therapy. The study involves patients who are already taking statins or a combination of statins and ezetimibe along with diet and exercise. These participants are assessed when they start using the fixed-dose combination of Pitavastatin and Ezetimibe, which may involve changing their statin formulation or dose or adding ezetimibe. Participants are observed over a period to monitor how well they reach their target LDL cholesterol levels 12 weeks after starting the combination therapy. During the study, participants will have their LDL cholesterol levels checked at 12 weeks to see if they meet the target goals. The study also monitors safety and any side effects while participants use the medication in real-life conditions. The study started in March 2024 and plans to continue until June 2026. Participants can expect regular follow-ups and assessments as part of the study to track treatment outcomes and safety.

A Study to Evaluate the Efficacy and Safety of Fixed-Dose Combination of Pitavastatin/Ezetimib