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 @ 3:53 PM
Ignite Modification Date:
2025-12-24 @ 3:53 PM
NCT ID:
NCT03882892
Eligibility Criteria:
Inclusion Criteria:
* Has successfully completed the 12-week double-blind, efficacy and safety parent study (P00692).
* If female, has a negative pregnancy test prior to study entry and, if of childbearing potential, agrees to practice an effective barrier method of birth control for the duration of the study and for 30 days after the last statin dose.
* If postmenopausal female receiving hormone therapy, a stable estrogen (ERT), estrogen/progestin (HRT) or raloxifene regimen must be maintained during the study period.
* Is willing to continue to follow their prescribed National Cholesterol Education Program (NCEP) Step 1 diet for the duration of the study.
Exclusion Criteria:
* Has discontinued from the parent study (P00692) prior to study completion.
* Is in a situation, or has any condition which, in the opinion of the investigator may interfere with optimal participation.
* Is a pregnant or lactating female.
* Is human immunodeficiency virus (HIV) positive.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
86 Years
Study:
NCT03882892
Study Brief:
Protocol Section:
NCT03882892