NCT07083206Recruiting
A Study to Evaluate the Effectiveness and Safety of Fixed-Dose Combination of Pitavastatin/ Ezetimibe
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
Source: ClinicalTrials.gov · Last updated 27 Oct 2026
Brief summary (registry, in English)
The objective of this study is to evaluate the effectiveness and safety of Pitavastatin/Ezetimibe FDC in patients with hypercholesterolemia.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 4500 (estimated)
- First submitted
- 16 Jul 2025
- Start date
- 29 Jul 2025
- Primary completion date
- 31 Jul 2028
- Lead sponsor
- Ahn-Gook Pharmaceuticals Co.,Ltd
- Diseases
- Familial hypercholesterolaemia
- NCT number
- NCT07083206
What you commit to
- Study type: Observational
- Planned participants: 4500
- From 29 Jul 2025 to the primary completion date, 31 Jul 2028
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Known hypersensitivity or history of hypersensitivity to any component of the investigational product
- Patients currently receiving cyclosporine treatment
Other illness
- Patients with active liver disease or persistent, unexplained elevations of aminotransferase levels
- Patients with severe hepatic impairment, biliary obstruction, or cholestasis
Lab values
- Patients with genetic disorders such as galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption
Other
- Patients diagnosed with myopathy
- Pregnant or breastfeeding women, or women who may be pregnant
- Any patient who, in the opinion of the investigator, is deemed unsuitable for study participation
Who the study is looking for
- 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
Age in the registry: 19 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Yongin Severance Hospital Coordinator of this site? Confirm its status | Yongin-si | South Korea | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.