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A Multi-center, Open-label, Observational Study to Evaluate the Efficacy and Safety of Pitavastatin/Ezetimibe Tablets in Patients With Dyslipidemia Who Also Have Metabolic Syndrome

Status: Recruiting
Location: See location...
Study Type: Observational
SUMMARY

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
Participation Requirements
Sex: All
Minimum Age: 19
Healthy Volunteers: f
View:

• 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

• Subjects who voluntarily sign the informed consent form for study participation

Locations
Other Locations
Republic of Korea
Chungnam National University Hospita
RECRUITING
Daejeon
Contact Information
Primary
EUNJU KIM
kej@jwhealthcare.com
82-2-840-6983
Time Frame
Start Date: 2025-06-25
Estimated Completion Date: 2027-06
Participants
Target number of participants: 10000
Treatments
Pitavastatin/Ezetimibe Group
Patients with dyslipidemia and metabolic syndrome who are prescribed a fixed-dose combination of Pitavastatin and Ezetimibe
Related Therapeutic Areas
Sponsors
Leads: JW Pharmaceutical

This content was sourced from clinicaltrials.gov

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