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 @ 12:18 AM
Ignite Modification Date:
2025-12-25 @ 12:18 AM
NCT ID:
NCT02364258
Eligibility Criteria:
Inclusion Criteria:
1. Children 8-21 years of age
2. LDL cholesterol \>130mg/dl (\>95% percentile)
3. Successfully genotyped for SLCO1B1
4. Willing to sign the assent/permission/consent form
Exclusion Criteria:
1. Underlying structural heart disease including congenital heart disease or acquired heart disease.
2. History or laboratory evidence of an underlying intestinal, metabolic, autoimmune, or renal disease that could alter the disposition of rosuvastatin or atorvastatin.
3. Underlying pathology of the gastrointestinal tract or recent surgery which would be expected to alter the rate and/or extent of drug absorption
4. Evidence of previous hypersensitivity to statin medications
5. Unwillingness or inability to have screening labs drawn
6. Refusal to participate in the study
7. Unwillingness or inability to participate in an overnight fast
8. Subjects taking drugs with interactions with statins (CYP3A4 inducers/inhibitors, OATP1B1 inducers/inhibitors) (Appendix 1)
9. Inability to swallow a tablet drug
10. For females, a positive urine beta-human chorionic gonadotropin pregnancy test result
11. Evidence of hepatic abnormality as determined by values \> 3 times the age-specific upper limit of normal for AST, ALT, total and conjugated bilirubin, serum albumin, Alkaline Phosphatase, and GGT.
12. Abnormal red blood cell morphology and/or a hemoglobin less than 9 gm/dl
13. Diarrhea in the last 24 hours
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
8 Years
Maximum Age:
21 Years
Study:
NCT02364258
Study Brief:
Protocol Section:
NCT02364258