Fixed-dose pitavastatin plus ezetimibe for lowering cholesterol

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study follows adults aged 19 and older who are being switched by their clinician from atorvastatin or rosuvastatin monotherapy to a fixed-dose combination of pitavastatin and ezetimibe. Investigators will use existing and follow-up laboratory data (TC, TG, HDL-C, LDL-C, AST, ALT, Cr/eGFR) to document changes in lipid levels and monitor safety. No experimental intervention beyond the clinically decided medication switch is imposed; outcomes are collected from routine care. The study is sponsored by Ahn-Gook Pharmaceuticals and conducted at Yongin Severance Hospital.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Adults aged 19 years or older
* Patients diagnosed with hypercholesterolemia who have been stably treated with atorvastatin or rosuvastatin monotherapy for at least 3 months, and for whom switching to fixed-dose combination pitavastatin/ezetimibe has been clinically decided
* Patients with available clinical laboratory test results related to efficacy and safety (TC, TG, HDL-C, LDL-C, AST, ALT, Cr/eGFR) within 12 months prior to switching to fixed-dose combination pitavastatin/ezetimibe (no changes in statin regimen or dosage during that period)
* Individuals (or their legally authorized representatives) who voluntarily provide written informed consent to participate in the study

Exclusion Criteria:

* Known hypersensitivity or history of hypersensitivity to any component of the investigational product
* Patients with active liver disease or persistent, unexplained elevations of aminotransferase levels
* Patients with severe hepatic impairment, biliary obstruction, or cholestasis
* Patients currently receiving cyclosporine treatment
* Patients diagnosed with myopathy
* Pregnant or breastfeeding women, or women who may be pregnant
* Patients with genetic disorders such as galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption
* Any patient who, in the opinion of the investigator, is deemed unsuitable for study participation

Where it's running

• Yongin Severance Hospital
  Yongin-si, South Korea Recruiting

Study contacts

• Principal investigator: Deok Kyu Cho — Severance Hospital
• Study coordinator: Hyunji Kim
• Email: hyunji.kim@ahn-gook.com
• Phone: +82-2-3289-4215

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.