NCT07523971 Efficacy and Safety of Pitavastatin/Ezetimibe in Dyslipidemia Patients With Metabolic Syndrome: An Observational Study
| NCT ID | NCT07523971 |
| Status | Recruiting |
| Phase | — |
| Sponsor | JW Pharmaceutical |
| Condition | Dyslipidemias |
| Study Type | OBSERVATIONAL |
| Enrollment | 10,000 participants |
| Start Date | 2025-06-25 |
| Primary Completion | 2026-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 10,000 participants in total. It began in 2025-06-25 with a primary completion date of 2026-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07523971 clinical trial?
This trial is open to participants of all sexes, aged 19 Years or older, studying Dyslipidemias. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07523971 currently recruiting?
Yes, NCT07523971 is actively recruiting participants. Contact the research team at kej@jwhealthcare.com for enrollment information.
Where is the NCT07523971 trial being conducted?
This trial is being conducted at Daejeon, South Korea.
Who is sponsoring the NCT07523971 clinical trial?
NCT07523971 is sponsored by JW Pharmaceutical. The trial plans to enroll 10,000 participants.