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 @ 4:12 PM
Ignite Modification Date:
2025-12-24 @ 4:12 PM
NCT ID:
NCT03947866
Eligibility Criteria:
Inclusion Criteria:
* Adult patients who have voluntarily consented to participate in the study.
* Adult patients who are already on treatment with the stable combination of ezetimibe-rosuvastatin (Lipopen), at the discretion of the treating physician.
* Adult patient adequately controlled with rosuvastatin and ezetimibe according to ESC / EAS 2019 guidelines.
Exclusion Criteria:
* Patients who have not fully understood the study procedures and have not signed the consent form.
* Patients who are contraindicated for taking the drug according to the Summary of Product Characteristics (MSF) of the study drug.
Hypersensitivity to the active substances or to any of the excipients of Lipopen.
* Pregnancy and breastfeeding.
* Active liver disease involving unexplained, persistent increases in serum transaminases and any increase in serum transaminases that exceeds 3 times the normal upper limit (ULN) or unexplained persistent increases in serum transaminases.
* Patient with severe renal impairment (creatinine clearance \<30 ml / min).
* Patient with myopathy
* Patient receiving concomitant treatment with cyclosporine
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
90 Years
Study:
NCT03947866
Study Brief:
Protocol Section:
NCT03947866