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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

4500 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-07-29

Study Completion Date

2029-01-31

Brief Summary

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

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Detailed Description

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Conditions

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Hypercholesterolemia Dyslipidemias

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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

Minimum Eligible Age

19 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No