A Study to Evaluate the Effectiveness and Safety of Fixed-Dose Combination of Pitavastatin/ Ezetimibe
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Hypercholesterolemia, Dyslipidemias. Basic parameters: from 19 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- South Korea
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
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
Overview
The objective of this study is to evaluate the effectiveness and safety of Pitavastatin/Ezetimibe FDC in patients with hypercholesterolemia.
Primary outcome measures
- Rate of reaching the target LDL-C level [Time frame: 12 months after administration]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
South Korea · 1 center
- Yongin Severance Hospital — Yongin-si
Identifiers
NCT: NCT07083206 · Pitaeze_OS