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 @ 4:26 PM
Ignite Modification Date:
2025-12-24 @ 4:26 PM
NCT ID:
NCT02081066
Eligibility Criteria:
Inclusion Criteria:
* Signed informed consent prior to initiation of the study
* Men and women aged 18 or more years
* Patients displaying at least one abnormal plasma lipid parameter and/or receiving a lipid-lowering therapy unchanged for at least 3 months.
Exclusion Criteria:
* Current significant renal disease, including: nephrotic syndrome; chronic renal failure and/or serum creatinine \>1.7 x upper limit of the reference range (ULRR)
* Uncontrolled hypothyroidism defined as TSH \>2 x ULRR
* Active hepatobiliary disease, including chronic hepatitis B or hepatitis C infection (confirmed by serology); or an aspartate aminotransferase (AST/SGOT) or alanine aminotransferase (ALT/SGPT) \>3.0 x ULRR
* Any prior history of malignancy or current cancer
* Current chronic or acute inflammatory syndrome defined as CRP\>10 mg/l
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT02081066
Study Brief:
Protocol Section:
NCT02081066