Recruiting NCT06314919
A Study to Evaluate the Efficacy and Safety of Fixed-Dose Combination of Pitavastatin/Ezetimib
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: Primary Hypercholesterolemia, Mixed Dyslipidemia. 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 Multicenter, Prospective, Cohort Study to Evaluate the Efficacy and Safety of Fixed-Dose Combination of Pitavastatin/Ezetimibe Under the Real-World Condition
Overview
The purpose of this study is to evaluate the efficacy and safety of fixed-Dose combination of Pitavastatin/Ezetimibe under the real-world condition
Primary outcome measures
- Rate of reaching the target LDL Cholesterol level [Time frame: 12 weeks after administration]
Eligibility criteria
Inclusion criteria
- Those who taking statins or statins and ezetimibe in addition to dietary and exercise therapy for primary hypercholesterolemia or mixed hyperlipidemia
- Those who are judged to need administration of a fixed-dose combination of pitavastatin/ezetimibe for change of statin's formulation or change of statin's dose, addition of ezetimibe
Exclusion criteria
- Those who are taking a fixed-dose combination of pitavastatin/ezetimibe at study enrollment
- Those with hypersensitivity reactions or relevant medical history to pitavastatin or ezetimibe
- Those who have been administered an investigational product within 12 weeks of the enrollment date or are planning to participate in another clinical trial during this study participation period.
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
- Ewha Womans University Seoul Hospital — Seoul
Identifiers
NCT: NCT06314919 · BR-PEC-OS-401