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 @ 12:59 AM
Ignite Modification Date:
2025-12-25 @ 12:59 AM
NCT ID:
NCT00891293
Eligibility Criteria:
Subjects were men and women who had successfully completed the previous open-label extension study (LOV111860/OM5X) and had met all inclusion and exclusion criteria for the original double-blind study (LOV111859/OM5) and throughout LOV111860/OM5X, or who had a renewed waiver of a previously approved protocol deviation.
Eligibility for entry into this study was based on the inclusion/exclusion criteria described of the double-blind LOV111859/OM5 protocol.
Subjects were men and women who had successfully completed the previous open-label extension study (LOV111860/OM5X) and had met all inclusion and exclusion criteria for the original double-blind study (LOV111859/OM5) and throughout LOV111860/OM5X, or who had a renewed waiver of a previously approved protocol deviation. The main eligibility criteria for LOV111859/OM5 were,
* 18 to79 years of age (inclusive) at screening
* fasting serum TG levels ≥500 mg/dL and \<1300 mg/dL
* BMI ≥ 25 kg/m2 and ≤43 kg/m2.
Subjects enrolled directly from the end of LOV111860/OM5X into LOV111821/OM5XX.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
79 Years
Study:
NCT00891293
Study Brief:
Protocol Section:
NCT00891293