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

NCT07083206 — Recruiting, 4500 participants, Ahn-Gook Pharmaceuticals Co.,Ltd

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A Multi-center, Prospective, Non-intervention, Observational Study to Evaluate the Effectiveness and Safety of Switching to Pevarozet Tablet in Patients With Hypercholesterolemia Previously Treated With Atorvastatin or Rosuvastatin Monotherapy

RegistryNCT07083206, acronym PIVOTAL
StatusRecruiting
Study typeObservational
Enrollment4500 (Estimated)
SponsorAhn-Gook Pharmaceuticals Co.,Ltd (Industry)
ConditionsHypercholesterolemia, Dyslipidemias
Datesstart 2025-07-29, primary completion 2028-07-01 (estimated), completion 2029-01-01 (estimated), first posted 2025-07-24, last updated 2025-08-07
Locations1 site in South Korea

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-Summary

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

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+Outcome measures

Primary outcomes

  • Rate of reaching the target LDL-C level [12 months after administration]

+Eligibility

Sex: All, ages: 19 Years to any

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

+Locations (1)

FacilityCityCountryStatus
Yongin Severance HospitalYongin-siSouth KoreaRecruiting

+Investigators

My Notes