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:
2025-12-25 @ 2:18 AM
Ignite Modification Date:
2025-12-25 @ 2:18 AM
NCT ID:
NCT01321034
Eligibility Criteria:
Inclusion Criteria:
1. Age \>18 and \< 80 years
2. LDL cholesterol between 70 and 190 mg/dL
3. Triglycerides \< 500 mg/dL
4. At least 2 Lp(a) determinations previous to the beginning of the study without differences \>20% or \> 20 mg/dL.
5. No lipid lowering therapy or on stable doses in the last 3 months
Exclusion Criteria:
1. Liver disease or liver enzymes \>2 times higher than reference values
2. Creatinine \> 2 mg/dL
3. Active peptic ulcer
4. Clinical gout in the last year
5. Uncontrolled diabetes (HbA1c \>8%)
6. Enrolment in other drug clinical trial in the previous 3 months.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT01321034
Study Brief:
Protocol Section:
NCT01321034