Phase
Condition
Hypercholesterolemia
Treatment
Atorvastatin, Probucol, Cilostazol
Clinical Study ID
Ages 18-70 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
The subject whose voluntary written informed consent is obtained for participationin this study;
18≤age≤70;
The subject with low-density lipoprotein cholesterol (LDL-C) ≥ 4.66 mmol/L (180mg/dL) (the highest level either pre-treatment or on treatment);
The subject with ATT≥9mm.
Exclusion
Exclusion Criteria:
The subject with homozygous familial hyperlipidemia;
The subject who took Probucol within 6 months before the screening test;
The subject who took Cilostazol within 1 month before the screening test;
The subject who took Ezetimibe within 1 month before the screening test;
The subject who hoped to treat with Ezetimibe within this study period;
The subject being treated with Cyclosporine;
The subject with a history of hypersensitivity to Probucol and Cilostazol;
The subject with a triglyceride (TG) level greater than 4.52 mmol/L (400 mg/dL);
The subject with diabetes: HbA1c level greater than 8.4% (NGSP);
The subject with New York Heart Association (NYHA) classification: Class III and IV;
The subject with a QTc interval greater than 450 msec (male) or 470 msec (female);
The subject with serious ventricular arrythmias (frequent episodes of multifocalventricular extrasystole);
The subject with atrial fibrillation (including paroxysmal atrial fibrillation);
The subject with congestive cardiac failure or unstable angina;
The subject with liver and renal functions that satisfy the following criteriawithin 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)
The subject who are participating in another clinical trial;
Woman during pregnancy or potential pregnancy, and breastfeeding;
Women of childbearing potential who are not agree to use an appropriate method ofcontraception;
The subject who are not considered by the Investigators to be appropriate toparticipate in this study for any other reasons.
Study Design
Study Description
Connect with a study center
Anzhen hospital
Beijing,
ChinaSite Not Available
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