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 @ 3:54 PM
Ignite Modification Date:
2025-12-24 @ 3:54 PM
NCT ID:
NCT05399992
Eligibility Criteria:
Inclusion Criteria:
1. Participants who are 18 years or older
2. Participants with hypercholesterolemia having a diagnosis of ASCVD, ASCVD RE or HeFH
3. Participants who are not at LDL-C goal as per their CV risk according to respective clinical guidelines
4. Participants who per physician's criteria need to optimize their LLT
5. Participants who provide written informed consent to participate in the study
6. Participants who initiate inclisiran under conditions per local label and have LDL-C values available at baseline or within 3 months before treatment initiation.
Exclusion Criteria:
1. Participants that have received inclisiran previously
2. Participants participating in a clinical trial with investigational product 3 Participants switching from previous PCSK9 mab treatment (within 90 days prior to Index date)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
100 Years
Study:
NCT05399992
Study Brief:
Protocol Section:
NCT05399992