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A Study to Evaluate the Effectiveness and Safety of Fixed-Dose Combination of Pitavastatin/ Ezetimibe

Recruitingn/aAges 19 Years - anyAllAhn-Gook Pharmaceuticals Co.,Ltd
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In plain words

What the trial is, and whether it could suit you

The objective of this study is to evaluate the effectiveness and safety of Pitavastatin/Ezetimibe FDC in patients with hypercholesterolemia.

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๐Ÿ“‹ Eligibility rules (as published)
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
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What it tests

  • Not listed
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Where

1 site
Yongin Severance Hospital
Yongin-si, South Korea
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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