NCT07083206 A Study to Evaluate the Effectiveness and Safety of Fixed-Dose Combination of Pitavastatin/ Ezetimibe
| NCT ID | NCT07083206 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Ahn-Gook Pharmaceuticals Co.,Ltd |
| Condition | Hypercholesterolemia |
| Study Type | OBSERVATIONAL |
| Enrollment | 4,500 participants |
| Start Date | 2025-07-29 |
| Primary Completion | 2028-07 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 4,500 participants in total. It began in 2025-07-29 with a primary completion date of 2028-07.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The objective of this study is to evaluate the effectiveness and safety of Pitavastatin/Ezetimibe FDC in patients with hypercholesterolemia.
Eligibility Criteria
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
Contact & Investigator
Deok Kyu Cho
PRINCIPAL INVESTIGATOR
Severance Hospital
Frequently Asked Questions
Who can join the NCT07083206 clinical trial?
This trial is open to participants of all sexes, aged 19 Years or older, studying Hypercholesterolemia. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07083206 currently recruiting?
Yes, NCT07083206 is actively recruiting participants. Contact the research team at hyunji.kim@ahn-gook.com for enrollment information.
Where is the NCT07083206 trial being conducted?
This trial is being conducted at Yongin-si, South Korea.
Who is sponsoring the NCT07083206 clinical trial?
NCT07083206 is sponsored by Ahn-Gook Pharmaceuticals Co.,Ltd. The principal investigator is Deok Kyu Cho at Severance Hospital. The trial plans to enroll 4,500 participants.