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

Last updated: August 3, 2025
Sponsor: Ahn-Gook Pharmaceuticals Co.,Ltd
Overall Status: Active - Recruiting

Phase

N/A

Condition

Hypercholesterolemia

Treatment

N/A

Clinical Study ID

NCT07083206
Pitaeze_OS
  • Ages > 19
  • All Genders

Study Summary

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

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Adults aged 19 years or older

  • Patients diagnosed with hypercholesterolemia who have been stably treated withatorvastatin or rosuvastatin monotherapy for at least 3 months, and for whomswitching to fixed-dose combination pitavastatin/ezetimibe has been clinicallydecided

  • Patients with available clinical laboratory test results related to efficacy andsafety (TC, TG, HDL-C, LDL-C, AST, ALT, Cr/eGFR) within 12 months prior to switchingto fixed-dose combination pitavastatin/ezetimibe (no changes in statin regimen ordosage during that period)

  • Individuals (or their legally authorized representatives) who voluntarily providewritten informed consent to participate in the study

Exclusion

Exclusion Criteria:

  • Known hypersensitivity or history of hypersensitivity to any component of theinvestigational product

  • Patients with active liver disease or persistent, unexplained elevations ofaminotransferase 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 lactasedeficiency, or glucose-galactose malabsorption

  • Any patient who, in the opinion of the investigator, is deemed unsuitable for studyparticipation

Study Design

Total Participants: 4500
Study Start date:
July 29, 2025
Estimated Completion Date:
January 31, 2029

Connect with a study center

  • Yongin Severance Hospital

    Yongin-si,
    Korea, Republic of

    Active - Recruiting

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