A Study to Evaluate the Efficacy and Safety of Fixed-Dose Combination of Pitavastatin/Ezetimib

Launched by BORYUNG PHARMACEUTICAL CO., LTD · Mar 11, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a combination medication made up of two drugs, Pitavastatin and Ezetimibe, to see how well it works and how safe it is for people with high cholesterol levels, specifically those with primary hypercholesterolemia or mixed dyslipidemia. The goal is to evaluate this treatment in real-life situations to understand its effectiveness better.

To be eligible for this study, participants should currently be taking statins, either alone or with Ezetimibe, and should be following a healthy diet and exercise plan. They also need to feel that they would benefit from switching to or adding this fixed-dose combination. However, individuals who are already taking this specific combination or have certain allergies or medical histories related to these medications cannot participate. If you join the study, you can expect regular check-ins and support as researchers gather information on how the treatment affects you. Overall, this trial aims to provide important insights that could help many people manage their cholesterol levels more effectively.

Gender

ALL

Eligibility 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.