NCT07523971

Efficacy and Safety of Pitavastatin/Ezetimibe in Dyslipidemia Patients With Metabolic Syndrome: An Observational Study

A Multi-center, Open-label, Observational Study to Evaluate the Efficacy and Safety of Pitavastatin/Ezetimibe Tablets in Patients With Dyslipidemia Who Also Have Metabolic Syndrome

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 10,000 (estimated)
• Sponsor: JW Pharmaceutical · Industry
• Sex: All
• Age: 19 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate the efficacy and safety of Pitavastatin/Ezetimibe tablets (a fixed-dose combination of Pitavastatin and Ezetimibe) in patients with dyslipidemia who also have metabolic syndrome in a real-world clinical setting. As this is an observational study, participants will be treated according to the investigator's medical judgment and routine clinical practice. The study aims to observe the changes in low-density lipoprotein cholesterol (LDL-C) levels from baseline to 24 weeks and 48 weeks of treatment. Safety will also be assessed by monitoring any adverse events occurring during the 48-week observation period.

Detailed description

This is a multi-center, open-label, prospective observational study designed to collect real-world evidence on the efficacy and safety of Pitavastatin/Ezetimibe tablets (2/10 mg and 4/10 mg). The study population consists of adult patients with dyslipidemia who satisfy the criteria for metabolic syndrome. Key study procedures and objectives include: Treatment: Participants who are prescribed Pitavastatin/Ezetimibe tablets as part of their routine care will be enrolled. No experimental intervention or forced treatment allocation will be performed. Efficacy Evaluation: The primary endpoint is the percentage change in LDL-C levels from baseline (Visit 1) to 24 weeks (Visit 2). Secondary endpoints include changes in other lipid parameters (Total Cholesterol, Triglycerides, HDL-C, non-HDL-C, Apo B) and the percentage of patients reaching their target LDL-C levels at 24 and 48 weeks. Safety Evaluation: All adverse events (AEs) and serious adverse events (SAEs) will be recorded and analyzed to assess the safety profile of the study drug in this specific patient population. Duration: Each participant will be observed for a total of 48 weeks, with visits occurring at baseline, 24 weeks, and 48 weeks. The results of this study are expected to provide clinical insights into the long-term management of dyslipidemia in patients with multiple metabolic risk factors using a pitavastatin/ezetimibe combination.

Conditions

• Dyslipidemias

Timeline

• Start date: 2025-06-25
• Primary completion: 2026-12-01
• Completion: 2027-06-01
• First posted: 2026-04-13
• Last updated: 2026-04-13

Locations

1 site across 1 country: South Korea