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 @ 11:34 PM
Ignite Modification Date:
2025-12-24 @ 11:34 PM
NCT ID:
NCT02275156
Eligibility Criteria:
Inclusion Criteria:
* Body mass index (BMI) of ≥ 18 and ≤ 35 kg/m² at screening.
* Subjects will have low-density lipoprotein cholesterol (LDL-C) of 70-190 mg/dL (inclusive) and on statin therapy.
* Other inclusion criteria may apply.
Exclusion Criteria:
* Subject with current or prior history of statin intolerance
* Subject has previously received Evolocumab (AMG 145) or any other investigational therapy directed against PCSK9
* Known substance abuse (eg, alcohol, licit or illicit drugs) within 12 months of day -1
* Testing positive for alcohol and/or drugs-of-abuse at screening, day -1, or day 1 (alcohol only)
* History of hypersensitivity or allergic reaction to mammalian-derived drug preparations
* Known sensitivity to any of the active substances or their excipients to be administered during dosing, eg, carboxymethylcellulose
* Other exclusion criteria may apply.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
70 Years
Study:
NCT02275156
Study Brief:
Protocol Section:
NCT02275156