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Pharmacokinetics of Rosuvastatin and Atorvastatin in Pediatric Dyslipidemia Patients

Children's Mercy Hospital Kansas City · 2014
ClinicalTrials.gov · Datasets · License: Public Domain · 2014
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dyslipidemia
This will be a single center, open label, randomized, cross-over study in patients with dyslipidemia comparing the pharmacokinetics of rosuvastatin and atorvastatin in patients with greater than or equal to one variant allele in the SLCO1B1 gene (-11187 and/or c.521) to patients with the wild-type/wild-type genotype. The studies goal is to establish the role of genetic variation and development in key transporters on the dose-exposure relationship of two commonly used statin drugs in children. This study is the first step in a series of investigations aimed to determining the mechanisms behind variations in physiologic response, clinical efficacy and significant adverse effect risk that surround the statin drugs in children and adolescents.
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