About this trial
The purpose of this study is to evaluate the efficacy and safety of Pitavastatin/Ezetimibe tablets (a fixed-dose combination of Pitavastatin and Ezetimibe) in patients with dyslipidemia who also have metabolic syndrome in a real-world clinical setting.
As this is an observational study, participants will be treated according to the investigator's medical judgment and routine clinical practice. The study aims to observe the changes in low-density lipoprotein cholesterol (LDL-C) levels from baseline to 24 weeks and 48 weeks of treatment. Safety will also be assessed by monitoring any adverse events occurring during the 48-week observation period.
Eligibility criteria
Qualifiers
Age 19 years old at the time of written informed consent
Subjects diagnosed with dyslipidemia and metabolic syndrome
Subjects who had no treatment history with lipid regulators within 4 weeks prior to Visit1 or who had insufficient therapeutic effects from 8 weeks of treatment with lipid regulators using the same dosage and administration
Subjects who meet the following LDL-C levels according to the classification of cardiovascular disease risk groups* at Visit 1 or who are planned to be treated with Pitavastatin/Ezetimibe Tablets based on the judgment of the investigator
Disqualifiers
Individuals for whom Pitavastatin/Ezetimibe Tablets is contraindicated as specified in the label's Precautions for Use
Individuals who were treated with other investigational products (IP) or investigational devices within 4 weeks prior to participation in the present study or who are expected to have such treatment during the present study
Individuals who are considered to have difficulty participating in the study for other reasons based on the judgment of the investigator
Trial design
Treatments tested in this trial
- Not listed
Trial groups
Locations
1Sponsors and collaborators
JW Pharmaceutical
Lead sponsor