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โ† Trials
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Liver Adiposity Effects on Pediatric Statin

RecruitingPhase 1Ages 8 Years - 21 YearsAllChildren's Mercy Hospital Kansas City
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In plain words

What the trial is, and whether it could suit you

Single center, open-label, prospective investigation to quantify the effects hepatocellular fat has on hepatic statin transport and response in children and adolescents in obese and non-obese children and adolescents 8-21 years of age with normal, wild-type SLCO1B1 c.521TT genotype that are dosed rosuvastatin

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
Inclusion Criteria: * 8-21 years * LDL cholesterol \>130mg/dl (\>95% percentile) * SLCO1B1 c.521TT genotype * Provide informed permission-assent(\<18 yrs.) or consent (โ‰ฅ18 yrs.) * Fasting overnight (\~8 hrs.) * Enrolled in Cardiology Pharmacogenomic Repository Exclusion Criteria: * Pregnancy * Non-fasting * Non-removable metal in body or MRI unsafe * Currently on statin therapy and unwilling to wash out of statin therapy for at least 4 weeks prior to Visit 1 and throughout the duration of the study. * Underlying unrepaired congenital or acquired cardiovascular defects or repaired congenital or acquired cardiovascular defects with hemodynamically significant residual disease. * History of underlying or laboratory evidence of underlying intestinal, metabolic, autoimmune, renal disease that can alter rosuvastatin disposition\* (absorption, metabolism, distribution, or clearance) * Pharmacotherapy that interacts with statins (OATP1B1 inducers/inhibitors) \* * Inability to swallow a tablet * \>5x the age-specific upper limit of normal for AST, ALT, total and conjugated bilirubin * Diarrhea in the last 24 hours * Anything that would exclude a participant from completing an MRI, such as pacemakers, claustrophobia, or body habitus (e.g., weight greater than 350 lbs.)
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What it tests

  • Rosuvastatin 10mg
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Where

1 site
Children's Mercy Hospital
Kansas City, United States
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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