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 @ 9:57 PM
Ignite Modification Date:
2025-12-24 @ 9:57 PM
NCT ID:
NCT06789432
Eligibility Criteria:
Inclusion Criteria:
* Men and women aged \>18 years.
* Patients with a confirmed diagnosis of elevated LDL-C levels necessitating medical management.
* Patients in the low to moderate cardiovascular disease (CVD) risk category according to ESC guidelines (2019)
* Low-risk: Increased LDL-C level without any co-morbidities
* Moderate-risk: Young patients (T1DM \<35 years; T2DM \<50 years) with DM duration \<10 years, without other risk factors.
Exclusion Criteria:
* History of hypersensitivity to any study drugs.
* Clinically significant hepatic impairment (ALT, AST level \> 2xULN) and/or renal impairment (Serum creatinine level ≥2xULN).
* Patients with hepatitis B virus (HBV) or hepatitis C virus (HCV) with cirrhosis, end-stage liver disease, cancer, psychiatric instability, HIV + status, intestinal malabsorption.
* Pregnant or lactating females.
* The presence of a condition that, in the opinion of the investigator, would place the subject at increased risk from study participation.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT06789432
Study Brief:
Protocol Section:
NCT06789432