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

Recruiting

• Conditions: Primary Hypercholesterolemia; Mixed Dyslipidemia

• Registration Number: NCT06314919
• Lead Sponsor: Boryung Pharmaceutical Co., Ltd

Brief Summary

The purpose of this study is to evaluate the efficacy and safety of fixed-Dose combination of Pitavastatin/Ezetimibe under the real-world condition

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-03-11
• Study First Submitted QC: 2024-03-11
• Study Start: 2024-03-15
• Study First Posted: 2024-03-18
• Status Verified: 2025-09
• Last Update Submitted: 2025-09-10
• Last Update Posted: 2025-09-12
• Primary Completion: 2026-06
• Study Completion: 2026-06-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 8606

Inclusion Criteria

• Those who taking statins or statins and ezetimibe in addition to dietary and exercise therapy for primary hypercholesterolemia or mixed hyperlipidemia
• Those who are judged to need administration of a fixed-dose combination of pitavastatin/ezetimibe for change of statin's formulation or change of statin's dose, addition of ezetimibe

Exclusion Criteria

• Those who are taking a fixed-dose combination of pitavastatin/ezetimibe at study enrollment
• Those with hypersensitivity reactions or relevant medical history to pitavastatin or ezetimibe
• Those who have been administered an investigational product within 12 weeks of the enrollment date or are planning to participate in another clinical trial during this study participation period.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Rate of reaching the target LDL Cholesterol level	12 weeks after administration

Trial Locations

Locations (1)

Ewha Womans University Seoul Hospital; 🇰🇷 Seoul, South Korea