Efficacy and Safety of Pitavastatin/Ezetimibe After Switching From Statin Monotherapy to Pitavastatin/Ezetimibe in Patients With Hypercholesterolemia

NCT07445542 | Completed

• 1 other identifier: JW21402
• Study Type: observational
• Target: 6,927
• Locations: 1 country
• Sites: 1

Brief Summary

A Multi-center, Open-label, Observational Study to evaluate the Efficacy and Safety of Pitavastatin/Ezetimibe after switching from Statin Monotherapy to Pitavastatin/Ezetimibe in patients with Hypercholesterolemia

Conditions

Hypercholesterolemia

Keywords

Hypercholesterolemia; Dyslipidemia; Statin Monotherapy; LDL Cholesterol; Pitavastatin and Ezetimibe Combination; Observational Study; Switching Study

Outcome Measures

Primary Outcomes (1)

• LDL-C level

  Percent change from baseline in LDL-C level at Week 24

  From enrollment to the end of treatment at 24 weeks

Study Arms (1)

switching to a fixed-dose combination of pitavastatin and ezetimibe

Patients with hypercholesterolemia who have been treated with a stable dose of statin monotherapy for at least 8 weeks and are switching to Pitavastatin/Ezetimibe

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study population includes adult patients (≥19 years) with hypercholesterolemia who are receiving routine clinical care at multiple centers in South Korea. The participants are those who have maintained a stable dose of statin monotherapy for at least 8 weeks and are switching to Pitavastatin/Ezetimibe as determined by the investigator. This observational study aims to reflect real-world clinical outcomes in patients undergoing this medication switch, provided they meet all eligibility criteria and provide written informed consent.

You may qualify if:

• Adults (≥19 years) with hypercholesterolemia.
• On a stable dose of statin monotherapy for at least 8 weeks.
• Scheduled to switch to Pitavastatin/Ezetimibe per investigator's decision.
• Provided voluntary written informed consent.

You may not qualify if:

• Use of other lipid-lowering therapies within 4 weeks before screening.
• History of clinically significant laboratory abnormalities within 1 year.
• Participation in other clinical trials within 4 weeks.
• Contraindications to Pitavastatin/Ezetimibe

Sponsors & Collaborators

• JW Pharmaceutical: lead

Study Sites (1)

Seoul Metropolitan Government Seoul National University Boramae Medical Center

Seoul, South Korea

Location

MeSH Terms

Conditions

Hypercholesterolemia; Dyslipidemias

Condition Hierarchy (Ancestors)

Hyperlipidemias; Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 25, 2026
• First Posted: March 3, 2026
• Study Start: December 18, 2021
• Primary Completion: May 13, 2025
• Study Completion: May 13, 2025
• Last Updated: March 3, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)