Actively Recruiting
A Multi-center Observational Study to Evaluate the Effectiveness and Safety of Switching to Pevarozet Tablet in Patients 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
On this page
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 Pitavastatin/Ezetimibe. 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
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 19 years or older
- Diagnosed with hypercholesterolemia and stably treated with atorvastatin or rosuvastatin monotherapy for at least 3 months
- Clinical decision to switch to fixed-dose combination Pitavastatin/Ezetimibe
- Available clinical laboratory test results related to efficacy and safety within 12 months prior to switching
- Voluntary written informed consent provided
You will not qualify if you...
- Known hypersensitivity to any component of the study medication
- Active liver disease or unexplained persistent elevated liver enzymes
- Severe hepatic impairment, biliary obstruction, or cholestasis
- Current cyclosporine treatment
- Diagnosis of myopathy
- Pregnant or breastfeeding women, or women who may be pregnant
- Genetic disorders such as galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption
- Any condition deemed unsuitable for participation by the investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - 12 months
Participants who switch to the fixed-dose combination of Pitavastatin/Ezetimibe are observed for effectiveness and safety.
Trial Site Locations
Total: 1 location
1
Yongin Severance Hospital
Yongin-si, South Korea
Actively Recruiting
Research Team
H
Hyunji Kim
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
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