A Study to Evaluate the Effectiveness and Safety of Fixed-Dose Combination of Pitavastatin/ Ezetimibe
Recruiting now
Conditions studied: Hypercholesterolemia, Dyslipidemias
In brief
The objective of this study is to evaluate the effectiveness and safety of Pitavastatin/Ezetimibe FDC in patients with hypercholesterolemia.
Key facts
- Study ID
- NCT07083206
- Run by
- Ahn-Gook Pharmaceuticals Co.,Ltd
- People needed
- 4500
- Starts
- 2025-07-29
- Expected to finish
- 2029-01-01
- Last updated by the study team
- 2025-08-07
Who can join
Age: 19 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- Yongin Severance Hospital — Yongin-si, South Korea (enrolling)
Full record on ClinicalTrials.gov
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