Fixed-dose pitavastatin plus ezetimibe for lowering cholesterol
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
This will try a single pill combining pitavastatin and ezetimibe to lower cholesterol in adults who have been stable on atorvastatin or rosuvastatin.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 4500 (estimated) |
| Ages | 19 Years and up |
| Sex | All |
| Sponsor | Ahn-Gook Pharmaceuticals Co.,Ltd Industry-sponsored |
| Locations | 1 site (Yongin-si) |
| Trial ID | NCT07083206 on ClinicalTrials.gov |
What this trial studies
This observational study follows adults aged 19 and older who are being switched by their clinician from atorvastatin or rosuvastatin monotherapy to a fixed-dose combination of pitavastatin and ezetimibe. Investigators will use existing and follow-up laboratory data (TC, TG, HDL-C, LDL-C, AST, ALT, Cr/eGFR) to document changes in lipid levels and monitor safety. No experimental intervention beyond the clinically decided medication switch is imposed; outcomes are collected from routine care. The study is sponsored by Ahn-Gook Pharmaceuticals and conducted at Yongin Severance Hospital.
Who should consider this trial
Good fit: Adults 19 years or older with hypercholesterolemia who have been on stable atorvastatin or rosuvastatin monotherapy for at least 3 months and are clinically being switched to pitavastatin/ezetimibe with available recent lab results are ideal candidates.
Not a fit: Patients with known allergy to component drugs, active or severe liver disease, severe hepatic impairment, or those not being switched from the specified statins are unlikely to benefit from this observational switch.
Why it matters
Potential benefit: If successful, this could offer improved LDL cholesterol lowering and a simpler regimen that may increase adherence for some patients.
How similar studies have performed: Combining a statin with ezetimibe has been shown in multiple trials to lower LDL cholesterol more than statin alone, while fixed-dose pitavastatin/ezetimibe specifically has had more limited but promising data.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Yongin-si
- Yongin Severance Hospital — Yongin-si, South Korea (Recruiting)
Study contacts
- Principal investigator: Deok Kyu Cho — Severance Hospital
- Study coordinator: Hyunji Kim
- Email: hyunji.kim@ahn-gook.com
- Phone: +82-2-3289-4215
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.