An OS to Evaluate the Safety & Efficacy of Fixed Dose Combination Therapy With Atorvastatin and Ezetimibe
- Conditions
- Primary Hypercholesterolemia
- Registration Number
- NCT05559606
- Lead Sponsor
- Boryung Pharmaceutical Co., Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 2700
Inclusion Criteria:<br><br> 1. Those who are briefed about the clinical trial objectives and methods, and express<br> their consent to participate in the trial by signing a written consent on the use of<br> their personal information.<br><br> 2. Any male/female subjects 19 years old or older.<br><br> 3. Those who will be given for the first time a fixed dose combination therapy with<br> atorvastatin and ezetimibe to treat primary hypercholesterolemia.<br><br> 4. Those with levels of total cholesterol, LDL-C, HDL-C, non-HDL-C and TG confirmed<br> within 2 weeks prior to the registration.<br><br> 5. Those who failed to reach to the target LDL-C level per risk group based on the risk<br> group classification specified in the therapeutic guideline for dyslipidemia (2018).<br><br> [Risk Group, Target LDL-C (mg/dL) Level]<br><br> - Very High Risk <70<br><br> - Coronary artery disease<br><br> - Atherosclerotic ischemic stroke and transient cerebral ischemic attack<br><br> - Peripheral arterial disease<br><br> - High Risk <100<br><br> - Carotid disease (When significant carotid artery stenosis is diagnosed)<br><br> - Abdominal aneurysm<br><br> - Diabetes (For patients with major risk factors such as damage to target<br> organs or cardiovascular diseases, the target level may be lowered based<br> on the patient conditions)<br><br> - Moderate Risk <130<br><br> - 2 or more major risk factors(May include age (45 years old for male<br> subjects and 55 years old for female subjects), family history of initial<br> coronary artery disease stage, hypertension, smoking, low HDL-C)<br><br> - Low Risk <160<br><br> - 1 or less major risk factors(May include age (45 years old for male<br> subjects and 55 years old for female subjects), family history of initial<br> coronary artery disease stage, hypertension, smoking, low HDL-C)<br><br> 6. Those who fully understand the clinical trial, are cooperative throughout the trial<br> and capable of participating in the trial until it ends.<br><br>Exclusion Criteria:<br><br> 1. Those who are hypersensitive to major ingredients or other ingredients of the<br> investigational drug.<br><br> 2. Hypertriglyceridemia patients whose triglyceride level is 400mg/dL or higher under<br> fasting conditions.<br><br> 3. Patients with serious hepatopathy (whose ALT or AST level is more than twice the<br> upper limit of normal (ULN)).<br><br> 4. Patients with serious nephropathy.<br><br> 5. Those who have medical history of myopathy and rhabdomyolysis.<br><br> 6. Female patients who are pregnant, suspected to be pregnant or breastfeeding.<br><br> 7. Those who are administrating glecaprevir and pibrentasvir.<br><br> 8. The drug contains lactose, thus those who have genetic problems, including galactose<br> intolerance, Lapp lactase deficiency and glucose-galactose malabsorption.<br><br> 9. Those who are currently participating in other clinical trials (any trials with<br> drugs or medical devices) or who have been administered with investigational drugs<br> of other clinical trials within 4 weeks from the baseline. However, those<br> participating in non-interventional trials or being observed after the drug<br> administration is complete may take part in the trial.<br><br> 10. Those who are currently hospitalized or are expected to be hospitalized.<br><br> 11. Those who are suffering from severe or unstable medical and mental illnesses that<br> may impact the trial as assessed by the investigators.
Not provided
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Rate of reaching the target LDL-C level
- Secondary Outcome Measures
Name Time Method Rate of reaching the target LDL-C level;Rate of change compared to the baseline when it comes to the level of TC, TG, LDL-C, HDL-C and non-HDL-C