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

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

Recruiting
19 years and older
All
Phase N/A

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Overview

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

Eligibility

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

Study details
    Hypercholesterolemia
    Dyslipidemias

NCT07083206

Ahn-Gook Pharmaceuticals Co.,Ltd

16 August 2025

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FAQs

Learn more about clinical trials

What is a clinical trial?

A clinical trial is a study designed to test specific interventions or treatments' effectiveness and safety, paving the way for new, innovative healthcare solutions.

Why should I take part in a clinical trial?

Participating in a clinical trial provides early access to potentially effective treatments and directly contributes to the healthcare advancements that benefit us all.

How long does a clinical trial take place?

The duration of clinical trials varies. Some trials last weeks, some years, depending on the phase and intention of the trial.

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Clinical trials follow strict ethical guidelines and protocols to safeguard participants' health. They are closely monitored and safety reviewed regularly.
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