Fixed-dose pitavastatin/ezetimibe for adults with dyslipidemia and metabolic syndrome

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a prospective, multicenter, open-label observational study enrolling adults diagnosed with dyslipidemia who meet criteria for metabolic syndrome and who are prescribed pitavastatin/ezetimibe (2/10 mg or 4/10 mg) as part of routine care. No treatment is assigned by the protocol; investigators will treat patients according to usual practice and the study will record outcomes at baseline, 24 weeks and 48 weeks. The primary outcome is percent change in LDL-C from baseline to 24 weeks, with secondary lipid endpoints and the proportion reaching LDL-C targets at 24 and 48 weeks. Safety will be monitored by recording adverse events and serious adverse events throughout the 48-week observation period.

Why it matters

Who can join: the full rules

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

Where it's running

• Chungnam National University Hospita
  Daejeon, South Korea Recruiting

Study contacts

• Study coordinator: Eunju Kim
• Email: kej@jwhealthcare.com
• Phone: 82-2-840-6983

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.