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 @ 4:02 PM
Ignite Modification Date:
2025-12-24 @ 4:02 PM
NCT ID:
NCT06810466
Eligibility Criteria:
Inclusion Criteria:
* Prevention of cardiovascular disease
* Low cardiovascular risk (\< 5%)
* Sub-optimal serum levels of LDL-C (130-136 mg/dl; 3.37-4.14 mmol/l) and/or non-HDL-C (160-190 mg/dl; 4.14-4.92 mmol/l) at T-2
* Signature of informed consent.
Exclusion Criteria:
* Patients with cardiovascular disease (in secondary prevention) or at risk of cardiovascular disease after 10 years (cardiovascular risk \>/= 5)
* diabetes mellitus
* Taking hypolipemiants, supplements or drugs that may involve lipid metabolism
* Hypertension treatment not stabilized for at least 3 months
* History of ongoing kidney, thyroid, gastrointestinal, muscle or liver disease
* Any medical-surgical treatment that may limit adherence to the study protocol
* Pregnant and/or breastfeeding women
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
69 Years
Study:
NCT06810466
Study Brief:
Protocol Section:
NCT06810466