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โ† Trials
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Efficacy and Safety of Pitavastatin/Ezetimibe in Dyslipidemia Patients With Metabolic Syndrome: An Observational Study

Recruitingn/aAges 19 Years - anyAllJW Pharmaceutical
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In plain words

What the trial is, and whether it could suit you

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.

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๐Ÿ“‹ Eligibility rules (as published)
Inclusion Criteria: 1. Age 19 years old at the time of written informed consent 2. Subjects diagnosed with dyslipidemia and metabolic syndrome 3. 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 4. 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 5. Subjects who voluntarily sign the informed consent form for study participation Exclusion Criteria: 1. Individuals for whom Pitavastatin/Ezetimibe Tablets is contraindicated as specified in the label's Precautions for Use 2. 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 3. Individuals who are considered to have difficulty participating in the study for other reasons based on the judgment of the investigator
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What it tests

  • Not listed
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Where

1 site
Chungnam National University Hospita
Daejeon, South Korea
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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