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OpenTrials
Completed

NCT Number: NCT07445542

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

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Key information

Conditions

Hypercholesterolemia Dyslipidemias Hyperlipidemias Lipid Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

19 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Seoul Metropolitan Government Seoul National University Boramae Medical Center

Seoul, South Korea

About this study

A Multi-center, Open-label, Observational Study

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

JW Pharmaceutical

Industry

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2025
Study completion
2025
First posted
Mar 3, 2026
Registry last updated
Mar 3, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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