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:
2025-12-25 @ 2:13 AM
Ignite Modification Date:
2025-12-25 @ 2:13 AM
NCT ID:
NCT02098460
Eligibility Criteria:
Inclusion Criteria:
1. The subject whose voluntary written informed consent is obtained for participation in this study;
2. 18≤age≤70；
3. The subject with low-density lipoprotein cholesterol (LDL-C) ≥ 4.66 mmol/L (180 mg/dL) (the highest level either pre-treatment or on treatment);
4. The subject with ATT≥9mm.
Exclusion Criteria:
1. The subject with homozygous familial hyperlipidemia;
2. The subject who took Probucol within 6 months before the screening test;
3. The subject who took Cilostazol within 1 month before the screening test;
4. The subject who took Ezetimibe within 1 month before the screening test;
5. The subject who hoped to treat with Ezetimibe within this study period;
6. The subject being treated with Cyclosporine;
7. The subject with a history of hypersensitivity to Probucol and Cilostazol;
8. The subject with a triglyceride (TG) level greater than 4.52 mmol/L (400 mg/dL);
9. The subject with diabetes: HbA1c level greater than 8.4% (NGSP);
10. The subject with New York Heart Association (NYHA) classification: Class III and IV;
11. The subject with a QTc interval greater than 450 msec (male) or 470 msec (female);
12. The subject with serious ventricular arrythmias (frequent episodes of multifocal ventricular extrasystole);
13. The subject with atrial fibrillation (including paroxysmal atrial fibrillation);
14. The subject with congestive cardiac failure or unstable angina;
15. The subject with liver and renal functions that satisfy the following criteria within 28 days prior to start of the investigational medicinal product (IMP) administration.
* AST ≥100 IU/L, ALT≥100 IU/L
* Serum creatinine ≥1.5 mg/dL (133 µmol/L)
16. The subject who are participating in another clinical trial;
17. Woman during pregnancy or potential pregnancy, and breastfeeding;
18. Women of childbearing potential who are not agree to use an appropriate method of contraception;
19. The subject who are not considered by the Investigators to be appropriate to participate in this study for any other reasons.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
70 Years
Study:
NCT02098460
Study Brief:
Protocol Section:
NCT02098460