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 @ 10:57 AM
Ignite Modification Date:
2025-12-26 @ 10:57 AM
NCT ID:
NCT03337308
Eligibility Criteria:
Inclusion Criteria:
* Require lipid-modifying therapy for primary or secondary prevention of cardiovascular disease
* Fasting LDL-C ≥ 130 mg/dL for primary prevention or LDL-C ≥ 100 mg/dL for secondary prevention (history of HeFH and/or ASCVD)
* Treated with maximally tolerated statin therapy at stable dose for at least 4 weeks prior to screening
Exclusion Criteria:
* Total Fasting Triglyceride ≥ 400 mg/dL
* Renal Dysfunction or nephrotic syndrome or history of nephritis
* Significant cardiovascular disease or cardiovascular event within the past 3 months
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT03337308
Study Brief:
Protocol Section:
NCT03337308