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 @ 2:11 AM
Ignite Modification Date:
2025-12-25 @ 2:11 AM
NCT ID:
NCT01912560
Eligibility Criteria:
Inclusion Criteria:
* Between 18 and 69 years at Screening
* Hypertriglyceridemia (TG ≥ 200 mg/dL and \< 500 mg/dL and non-HDL-C ≥ 100 mg/dL and \< 220 mg/dL) OR
* Hypercholesterolemia (LDL-C ≥ 100 mg/dL and \< 190 mg/dL and TG value \< 200 mg/dL) plus a stable dose of statin for at least 4 weeks prior to Screening.
* Body mass index (BMI) ≤ 45 kg/m2
Exclusion Criteria:
* History of any major cardiovascular event within 6 months of Screening
* Type I diabetes mellitus
* Any condition that may predispose the patient to secondary hyperlipidemia, such as uncontrolled hypothyroidism
* Any statin at the highest approved dose
* Non-statin lipid-altering drugs other than cholesterol absorption inhibitors.
* Active peptic ulcer disease or a history of muscle disease or myopathy
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
69 Years
Study:
NCT01912560
Study Brief:
Protocol Section:
NCT01912560