Evaluating the effectiveness and safety of a combination medication for cholesterol management
A Multicenter, Prospective, Cohort Study to Evaluate the Efficacy and Safety of Fixed-Dose Combination of Pitavastatin/Ezetimibe Under the Real-World Condition
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 |
|---|---|
| Enrollment | 8606 (estimated) |
| Ages | 19 Years and up |
| Sex | All |
| Sponsor | Boryung Pharmaceutical Co., Ltd Industry-sponsored |
| Locations | 1 site (Seoul) |
| Trial ID | NCT06314919 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are individuals currently on statin therapy or a combination of statins and Ezetimibe who need a change in their treatment.
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.
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 performed: Other studies have shown success with similar fixed-dose combination approaches for cholesterol management, indicating potential for positive outcomes.
Eligibility criteria
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 this trial is running
Seoul
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.