Efficacy and Safety of Pitavastatin/Ezetimibe in Dyslipidemia Patients With Metabolic Syndrome: An Observational Study

NCT07523971 | Recruiting

• 1 other identifier: JW25403
• Study Type: observational
• Target: 10,000
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to evaluate the efficacy and safety of Pitavastatin/Ezetimibe tablets (a fixed-dose combination of Pitavastatin and Ezetimibe) in patients with dyslipidemia who also have metabolic syndrome in a real-world clinical setting. As this is an observational study, participants will be treated according to the investigator's medical judgment and routine clinical practice. The study aims to observe the changes in low-density lipoprotein cholesterol (LDL-C) levels from baseline to 24 weeks and 48 weeks of treatment. Safety will also be assessed by monitoring any adverse events occurring during the 48-week observation period.

Conditions

Dyslipidemias

Keywords

Metabolic Syndrome

Outcome Measures

Primary Outcomes (1)

• Percentage change

  Percentage change in LDL-C levels from baseline

  24 weeks

Study Arms (1)

Pitavastatin/Ezetimibe Group

Patients with dyslipidemia and metabolic syndrome who are prescribed a fixed-dose combination of Pitavastatin and 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

Dyslipidemia Who Also Have Metabolic Syndrome

You may qualify if:

• Age 19 years old at the time of written informed consent
• Subjects diagnosed with dyslipidemia and metabolic syndrome
• Subjects who had no treatment history with lipid regulators within 4 weeks prior to Visit1 or who had insufficient therapeutic effects from 8 weeks of treatment with lipid regulators using the same dosage and administration
• Subjects who meet the following LDL-C levels according to the classification of cardiovascular disease risk groups\* at Visit 1 or who are planned to be treated with Pitavastatin/Ezetimibe Tablets based on the judgment of the investigator
• Subjects who voluntarily sign the informed consent form for study participation

You may not qualify if:

• Individuals for whom Pitavastatin/Ezetimibe Tablets is contraindicated as specified in the label's Precautions for Use
• Individuals who were treated with other investigational products (IP) or investigational devices within 4 weeks prior to participation in the present study or who are expected to have such treatment during the present study
• Individuals who are considered to have difficulty participating in the study for other reasons based on the judgment of the investigator

Sponsors & Collaborators

• JW Pharmaceutical: lead

Study Sites (1)

Chungnam National University Hospita

Daejeon, South Korea

RECRUITING

MeSH Terms

Conditions

Dyslipidemias; Metabolic Syndrome

Condition Hierarchy (Ancestors)

Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Insulin Resistance; Hyperinsulinism; Glucose Metabolism Disorders

Central Study Contacts

EUNJU KIM

CONTACT

82-2-840-6983; kej@jwhealthcare.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Year
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 5, 2026
• First Posted: April 13, 2026
• Study Start: June 25, 2025
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): June 1, 2027
• Last Updated: April 13, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)