Pharmacokinetics of Rosuvastatin and Atorvastatin in Pediatric Dyslipidemia Patients
Status:
Completed
Trial end date:
2017-12-27
Target enrollment:
Participant gender:
Summary
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.