Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-26 @ 1:18 PM
Ignite Modification Date:
2025-12-26 @ 1:18 PM
NCT ID:
NCT05559606
Eligibility Criteria:
Inclusion Criteria:
1. Those who are briefed about the clinical trial objectives and methods, and express their consent to participate in the trial by signing a written consent on the use of their personal information.
2. Any male/female subjects 19 years old or older.
3. Those who will be given for the first time a fixed dose combination therapy with atorvastatin and ezetimibe to treat primary hypercholesterolemia.
4. Those with levels of total cholesterol, LDL-C, HDL-C, non-HDL-C and TG confirmed within 2 weeks prior to the registration.
5. Those who failed to reach to the target LDL-C level per risk group based on the risk group classification specified in the therapeutic guideline for dyslipidemia (2018).
\[Risk Group, Target LDL-C (mg/dL) Level\]
* Very High Risk \<70
* Coronary artery disease
* Atherosclerotic ischemic stroke and transient cerebral ischemic attack
* Peripheral arterial disease
* High Risk \<100
* Carotid disease (When significant carotid artery stenosis is diagnosed)
* Abdominal aneurysm
* Diabetes (For patients with major risk factors such as damage to target organs or cardiovascular diseases, the target level may be lowered based on the patient conditions)
* Moderate Risk \<130
* 2 or more major risk factors(May include age (45 years old for male subjects and 55 years old for female subjects), family history of initial coronary artery disease stage, hypertension, smoking, low HDL-C)
* Low Risk \<160
* 1 or less major risk factors(May include age (45 years old for male subjects and 55 years old for female subjects), family history of initial coronary artery disease stage, hypertension, smoking, low HDL-C)
6. Those who fully understand the clinical trial, are cooperative throughout the trial and capable of participating in the trial until it ends.
Exclusion Criteria:
1. Those who are hypersensitive to major ingredients or other ingredients of the investigational drug.
2. Hypertriglyceridemia patients whose triglyceride level is 400mg/dL or higher under fasting conditions.
3. Patients with serious hepatopathy (whose ALT or AST level is more than twice the upper limit of normal (ULN)).
4. Patients with serious nephropathy.
5. Those who have medical history of myopathy and rhabdomyolysis.
6. Female patients who are pregnant, suspected to be pregnant or breastfeeding.
7. Those who are administrating glecaprevir and pibrentasvir.
8. The drug contains lactose, thus those who have genetic problems, including galactose intolerance, Lapp lactase deficiency and glucose-galactose malabsorption.
9. Those who are currently participating in other clinical trials (any trials with drugs or medical devices) or who have been administered with investigational drugs of other clinical trials within 4 weeks from the baseline. However, those participating in non-interventional trials or being observed after the drug administration is complete may take part in the trial.
10. Those who are currently hospitalized or are expected to be hospitalized.
11. Those who are suffering from severe or unstable medical and mental illnesses that may impact the trial as assessed by the investigators.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
19 Years
Study:
NCT05559606
Study Brief:
Protocol Section:
NCT05559606