Clinical trial Recruiting at 1 site Observational Ages 19 and up

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 typeObservational
Ages19 Years and up
SexAll
Enrollment8606 (estimated)
SponsorBoryung Pharmaceutical Co., Ltd
Industry-sponsored
Locations1 site (Seoul)
StatusRecruiting
StartedMarch 15, 2024
Main results expectedJune 2026
Study endsJune 2026
Registry record updatedSeptember 12, 2025
Trial IDNCT06314919 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

  • Ewha Womans University Seoul Hospital
    Seoul, South Korea
    Recruiting

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.