Long-term Comparison of Pitavastatin/Ezetimibe and Pitavastatin in Patients With Hypercholesterolemia and Elevated Triglycerides

February 24, 2026 updated by: JW Pharmaceutical

A Multicenter Study to Evaluate Efficacy and Safety

A multicenter, randomized, double-blind, phase Ⅳ study to evaluate the long-term efficacy and safety of Pitavastatin/Ezetimibe and Pitavastatin in patients with hypercholesterolemia with elevated triglycerides

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

A multicenter study to evaluate efficacy and safety

Study Type

Interventional

Enrollment (Actual)

88

Phase

  • Phase 4

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
        • The Catholic University of Korea, Yeouido St. Mary's Hospital

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

Description

Inclusion Criteria:

  • Patients with hypercholesterolemia
  • Patients diagnosed with metabolic syndrome or type 2 diabetes mellitus, and presenting with elevated LDL-C

Exclusion Criteria:

  • New-onset acute cardio-cerebrovascular disease
  • Severe hepatic impairment
  • Active liver disease

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

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Pitavastatin/Ezetimibe Combination
FDC of Pitavastatin/Ezetimibe
Drug: Pitavastatin 4mg
Administered as a fixed-dose combination tablet (Pitavastatin/Ezetimibe 4/10 mg) orally once daily for 52 weeks.
Drug: Ezetimibe 10 mg
Administered as a fixed-dose combination tablet (Pitavastatin/Ezetimibe 4/10 mg) orally once daily for 52 weeks.
Drug: Placebo (for Pitavastatin)
Administered as a matching placebo tablet identical in appearance to Pitavastatin 4 mg monotherapy, orally once daily for 52 weeks.
Active Comparator: Pitavastatin Monotherapy
Pitavastatin
Drug: Pitavastatin 4mg
Administered as a fixed-dose combination tablet (Pitavastatin/Ezetimibe 4/10 mg) orally once daily for 52 weeks.
Drug: Placebo (for Pitavastatin/Ezetimibe)
Administered as a matching placebo tablet identical in appearance to the Pitavastatin/Ezetimibe 4/10 mg fixed-dose combination, orally once daily for 52 weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage change from baseline in LDL Cholesterol at Week 8 after the first dose of study treatment
Time Frame: Baseline to week 8
The unit of measure is percentage (%). The percentage change is calculated as: [(Value at Week 8 - Value at Baseline) / Value at Baseline] * 100
Baseline to week 8

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from baseline in HDL Cholesterol at Weeks 8, 24, and 52 after the first dose of study treatment
Time Frame: Baseline to week 8, 24, 52
Change = (Value at Week 8, 24, or 52) - (Value at Baseline), Unit of measure: mg/dL
Baseline to week 8, 24, 52
Change from baseline in Triglycerides at Weeks 8, 24, and 52 after the first dose of study treatment
Time Frame: Baseline to week 8, 24, 52
Change = (Value at Week 8, 24, or 52) - (Value at Baseline), Unit of measure: mg/dL
Baseline to week 8, 24, 52
Change from baseline in LDL Cholesterol at Weeks 8, 24, and 52 after the first dose of study treatment
Time Frame: Baseline to week 8, 24, 52
Change = (Value at Week 8, 24, or 52) - (Value at Baseline), Unit of measure: mg/dL
Baseline to week 8, 24, 52
Change from baseline in Non-alcoholic Fatty Liver Disease Liver Fat Score (NLFS) at Weeks 24 and 52
Time Frame: Baseline to week 24, 52
The NLFS is a calculated score used to estimate liver fat content. The change is calculated as (Value at Week 24 or 52) - (Value at Baseline).
Baseline to week 24, 52

Collaborators and Investigators

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

Sponsor

JW Pharmaceutical

Investigators

  • Principal Investigator: Hyuk Sang Kwon, The Catholic University of Korea, Yeouido St. Mary's Hospital, Principal Investigator

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)

August 21, 2023

Primary Completion (Actual)

January 22, 2026

Study Completion (Estimated)

November 30, 2026

Study Registration Dates

First Submitted

February 18, 2026

First Submitted That Met QC Criteria

February 24, 2026

First Posted (Actual)

March 2, 2026

Study Record Updates

Last Update Posted (Actual)

March 2, 2026

Last Update Submitted That Met QC Criteria

February 24, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • JW22401

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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