Efficacy and Safety of Pitavastatin/Ezetimibe After Switc... | NCT07445542

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

NCT07445542

Sponsor

JW Pharmaceutical

Status

Completed

Last Update Posted

Mar 3, 2026Actual

Enrollment

6,927Actual

Phase

Not provided

Conditions

Hypercholesterolemia

Interventions

Not provided

Countries

South Korea

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2026

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 18, 2021Actual

Primary Completion Date

May 13, 2025Actual

Completion Date

May 13, 2025Actual

First Submitted Date

Feb 25, 2026

First Submission Date that Met QC Criteria

Feb 25, 2026

First Posted Date

Mar 3, 2026Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 25, 2026

Last Update Posted Date

Mar 3, 2026Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Detailed Description

A Multi-center, Open-label, Observational Study

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

6,927Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Interventions

Not provided

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

19 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

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.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Seoul Metropolitan Government Seoul National University Boramae Medical Center		Seoul			South Korea

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D006937	Hypercholesterolemia
D050171	Dyslipidemias

Ancestor Terms

ID	Term
D006949	Hyperlipidemias
D052439	Lipid Metabolism Disorders
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided