Actively Recruiting

Age: 19Years +
All Genders
NCT07083206

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

Led by Ahn-Gook Pharmaceuticals Co.,Ltd · Updated on 2025-08-07

4500

Participants Needed

1

Research Sites

178 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

CONDITIONS

Official Title

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

Who Can Participate

Age: 19Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Adults aged 19 years or older
  • Diagnosed with hypercholesterolemia and stably treated with atorvastatin or rosuvastatin monotherapy for at least 3 months
  • Clinical laboratory test results related to cholesterol and liver/kidney function available within 12 months before switching treatment
  • Provided written informed consent to participate
Not Eligible

You will not qualify if you...

  • Known hypersensitivity to any component of the investigational product
  • Active liver disease or unexplained persistent elevation of liver enzymes
  • Severe liver impairment, biliary obstruction, or cholestasis
  • Currently receiving cyclosporine treatment
  • Diagnosed with myopathy
  • Pregnant or breastfeeding women, or women who may be pregnant
  • Genetic disorders such as galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption
  • Deemed unsuitable for study participation by the investigator

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Yongin Severance Hospital

Yongin-si, South Korea

Actively Recruiting

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Research Team

H

Hyunji Kim

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

0

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