Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE1
50 participants
INTERVENTIONAL
2021-04-01
2026-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Baseline Mevalonate and MRI Imaging
No interventions assigned to this group
Mevalonate Change After Rosuvastatin
Rosuvastatin 10mg
Rosuvastatin will be administered to all participants on Study Day #2
Interventions
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Rosuvastatin 10mg
Rosuvastatin will be administered to all participants on Study Day #2
Eligibility Criteria
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Inclusion Criteria
* LDL cholesterol \>130mg/dl (\>95% percentile)
* SLCO1B1 c.521TT genotype
* Provide informed permission-assent(\<18 yrs.) or consent (≥18 yrs.)
* Fasting overnight (\~8 hrs.)
* Enrolled in Cardiology Pharmacogenomic Repository
Exclusion Criteria
* 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.)
8 Years
21 Years
ALL
Yes
Sponsors
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Children's Mercy Hospital Kansas City
OTHER
Responsible Party
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Jon Wagner
Principal Investigator
Locations
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Children's Mercy Hospital
Kansas City, Missouri, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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STUDY00001550
Identifier Type: -
Identifier Source: org_study_id
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