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 @ 2:39 AM
Ignite Modification Date:
2025-12-25 @ 2:39 AM
NCT ID:
NCT02947334
Eligibility Criteria:
Inclusion Criteria:
* Males and females at the age or over 18 years of age.
* With primary hyperlipidemia or mixed dyslipidemia.
* Treated with stable daily dose of statins
* At high or very high risk of incurring a CV event
* Fasting LDL-C \>=70 mg/dL (1.81 mmol/L) for subjects on the highest approved dose of statins; Fasting LDL C \>=77 mg/dL (1.99 mmol/L) for subjects not on highest approved dose.
* Fasting TG ≤400 mg/dL (4.51 mmol/L)
Exclusion Criteria:
* Prior exposure to bococizumab or other investigational PCSK9 inhibitor
* NYHA class IV, or Left Ventricular Ejection Fraction \<25%
* Poorly controlled hypertension
* History of hemorrhagic stroke or lacunar infarction resulting in a stroke
* Untreated hyperthyroidism or TSH \>1 × ULN
* Undergoing apheresis or have planned start of apheresis.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT02947334
Study Brief:
Protocol Section:
NCT02947334