Evaluating the effectiveness and safety of a combination medication for cholesterol management
Official title: A Multicenter, Prospective, Cohort Study to Evaluate the Efficacy and Safety of Fixed-Dose Combination of Pitavastatin/Ezetimibe Under the Real-World Condition
Run by Boryung Pharmaceutical Co., Ltd · NCT06314919 · Data updated 2026-11-12
This study is testing a new combination medication for cholesterol management to see if it works better and is safe for people who need a change in their current cholesterol treatment.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 19 Years and up |
| Sex | All |
| Enrollment | 8606 (estimated) |
| Sponsor | Boryung Pharmaceutical Co., Ltd Industry-sponsored |
| Locations | 1 site (Seoul) |
| Status | Recruiting |
| Started | March 15, 2024 |
| Main results expected | June 2026 |
| Study ends | June 2026 |
| Registry record updated | September 12, 2025 |
| Trial ID | NCT06314919 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are individuals currently on statin therapy or a combination of statins and Ezetimibe who need a change in their treatment.
✕Probably not a fit
Patients who are already taking a fixed-dose combination of Pitavastatin and Ezetimibe at the time of enrollment will not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This study aims to assess the efficacy and safety of a fixed-dose combination of Pitavastatin and Ezetimibe in patients with primary hypercholesterolemia or mixed dyslipidemia under real-world conditions. Participants will be those currently taking statins or a combination of statins and Ezetimibe, who require a change in their medication regimen. The study will observe the outcomes of this combination therapy to determine its effectiveness in managing cholesterol levels.
Why it matters
Potential benefit: If successful, this study could provide a more effective treatment option for patients struggling with high cholesterol levels.
How similar studies have gone: Other studies have shown success with similar fixed-dose combination approaches for cholesterol management, indicating potential for positive outcomes.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Those who taking statins or statins and ezetimibe in addition to dietary and exercise therapy for primary hypercholesterolemia or mixed hyperlipidemia * Those who are judged to need administration of a fixed-dose combination of pitavastatin/ezetimibe for change of statin's formulation or change of statin's dose, addition of ezetimibe Exclusion Criteria: * Those who are taking a fixed-dose combination of pitavastatin/ezetimibe at study enrollment * Those with hypersensitivity reactions or relevant medical history to pitavastatin or ezetimibe * Those who have been administered an investigational product within 12 weeks of the enrollment date or are planning to participate in another clinical trial during this study participation period.
Where it's running
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Ewha Womans University Seoul Hospital
Seoul, South Korea Recruiting
Study contacts
- Study coordinator: Shin-young Oh
- Email: syoh@boryung.co.kr
- Phone: +82-2-708-8000
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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MWX203: a medicine for mixed dyslipidemia given alone or with Inclisiran
This phase 2 study tests MWX203 alone or with Inclisiran in adults with mixed dyslipidemia who don’t reach lipid goals on statins.
-
Obicetrapib vs. bempedoic acid for high-risk high cholesterol patients
This phase 3 study tests whether obicetrapib can lower LDL-C more than bempedoic acid in adults with primary non-familial hypercholesterolemia or mixed dyslipidemia who still have high LDL-C despite maximum tolerated therapy.
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Bempedoic Acid With Ezetiimibe in Adults with High Cholesterol or Mixed Dyslipidemia
This study tests bempedoic acid alone or with ezetimibe in real-world adults with primary hypercholesterolemia or mixed dyslipidemia to see how safe and effective it is in routine care.
-
Comparing the effects of two medications on healthy individuals
This study tests how two medications work in healthy people to see if one is safer or more effective than the other.
-
Evaluating HST101 for lowering cholesterol in Chinese patients
This study is testing if a new drug called HST101 can lower cholesterol levels in Chinese patients who have high cholesterol and are at risk for heart disease.
-
Evaluating the effectiveness and safety of AD-218 for mixed dyslipidemia
This study is testing if a new drug called AD-218 can help people with mixed dyslipidemia improve their cholesterol levels and overall health.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.