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 @ 7:06 PM
Ignite Modification Date:
2025-12-24 @ 7:06 PM
NCT ID:
NCT02571257
Eligibility Criteria:
Inclusion Criteria:
* Males and Females
* 18 to 65 years of age
* Baseline LDL-C ≥ 130 mg/dL (3.4 mmol/L)
Exclusion Criteria:
* If female, postmenopausal or surgically menopausal
* Triglycerides (TG) \>400 mg/dL
* Creatine phosphokinase (CPK) \>3 × the upper limit of normal (ULN)
* Body Mass Index (BMI) \>35 kg/m2
* Uncontrolled diabetes mellitus (HbA1c \>10%)
* Renal dysfunction (blood urea nitrogen \[BUN\] or creatinine \>2 × ULN)
* Hepatic dysfunction (aspartate aminotransferase \[AST\] or alanine aminotransferase \[ALT\] \>2 × ULN)
* Myocardial infarction, severe or unstable angina pectoris, coronary angioplasty, coronary artery bypass graft, or any other major cardiovascular event resulting in hospitalization in previous month
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT02571257
Study Brief:
Protocol Section:
NCT02571257