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:
2025-12-24 @ 7:24 PM
Ignite Modification Date:
2025-12-24 @ 7:24 PM
NCT ID:
NCT01414803
Eligibility Criteria:
Inclusion Criteria:
* mixed hyperlipidemia: total cholesterol levels higher than 220 mg/dL, triglyceride (TG) levels between 200 and 500 mg/dL, and low-density lipoprotein (LDL)-cholesterol levels higher than 130 mg/dL after 6-week diet/life style change
* Men and women who were between 20 and 70 years of age
* Having at least one history of: coronary artery disease, cerebrovascular disease or transient ischemic attack, peripheral vascular disease, or diabetes mellitus.
* Having risk factors at least two of: age ≥45 years in male or ≥55 years in female, elevated blood pressure (systolic blood pressure ≥130 mmHg or diastolic blood pressure ≥85 mmHg, or treatment of previously diagnosed hypertension), high-density lipoprotein (HDL)-cholesterol \<40 mg/dL, family history of coronary artery disease at age \<55 years in male or \<65 years in female, central obesity (waist circumference ≥90 cm for male or ≥80 cm for female), fasting plasma glucose ≥110 mg/dL, or left ventricular hypertrophy on electrocardiogram
* Written informed consent.
Exclusion Criteria:
* pregnant or breast-feeding
* uncontrolled hypertension
* uncontrolled diabetes mellitus
* thyroid dysfunction
* serum transaminase level \>2 times the upper limit of normal
* history of gall bladder disease
* chronic alcoholic
* serum creatinine level \>1.5 mg/dL
* history of myopathy
* history of acute myocardial infarction or acute stroke within 3 months before the study began
* acute or chronic infection or inflammation
* history of cancer
* history of adverse events associated with test drugs.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
20 Years
Maximum Age:
70 Years
Study:
NCT01414803
Study Brief:
Protocol Section:
NCT01414803