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

February 25, 2026 updated by: JW Pharmaceutical

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

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

Study Overview

Status

Completed

Conditions

Detailed Description

A Multi-center, Open-label, Observational Study

Study Type

Observational

Enrollment (Actual)

6927

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • South Korea
      • Seoul, South Korea
        • Seoul Metropolitan Government Seoul National University Boramae Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

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.

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
LDL-C level
Time Frame: From enrollment to the end of treatment at 24 weeks
Percent change from baseline in LDL-C level at Week 24
From enrollment to the end of treatment at 24 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

JW Pharmaceutical

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 18, 2021

Primary Completion (Actual)

May 13, 2025

Study Completion (Actual)

May 13, 2025

Study Registration Dates

First Submitted

February 25, 2026

First Submitted That Met QC Criteria

February 25, 2026

First Posted (Actual)

March 3, 2026

Study Record Updates

Last Update Posted (Actual)

March 3, 2026

Last Update Submitted That Met QC Criteria

February 25, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • JW21402

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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