Actively Recruiting
Observational Study on Effectiveness and Safety of Switching to Pevarozet Tablet in Adults With Hypercholesterolemia Previously Treated With Atorvastatin or Rosuvastatin
Led by Ahn-Gook Pharmaceuticals Co.,Ltd · Updated on 2025-08-07
4500
Participants Needed
1
Research Sites
26 weeks
Total Duration
AI-Summary
What this Trial Is About
Researchers are evaluating the effectiveness and safety of a fixed-dose combination of Pitavastatin and Ezetimibe in adults with hypercholesterolemia. This observational study specifically looks at patients who have previously been treated with either atorvastatin or rosuvastatin monotherapy and have been switched to the combination tablet. The goal is to understand how well this combination helps patients reach target LDL cholesterol levels over time. Participants in this study will be patients who have already been stably treated with atorvastatin or rosuvastatin for at least three months and have clinical decisions to switch to the fixed-dose combination pill of PitavastatinEzetimibe. The study will observe these patients prospectively, without any intervention from the researchers, to monitor their response to the new medication under normal clinical practice. During the study, patients will be monitored for lipid levels and safety through clinical laboratory tests, including total cholesterol, triglycerides, HDL cholesterol, LDL cholesterol, liver enzymes, and kidney function tests. The primary outcome is the rate of patients achieving their target LDL cholesterol level 12 months after starting the fixed-dose combination. Participants will be followed over this period to assess effectiveness and safety, ensuring their usual care continues alongside study observations.
CONDITIONS
Brief Title
A Study to Evaluate the Effectiveness and Safety of Fixed-Dose Combination of Pitavastatin/ Ezetimibe
Research Team
H
Hyunji Kim
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