MedTrace Logo

Pharmacokinetics of Rosuvastatin and Atorvastatin in Pediatric Dyslipidemia Patients

NCT02364258 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 28

Last updated 2019-01-31

No results posted yet for this study

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.

Conditions

Interventions

DRUG

Rosuvastatin

Rosuvastatin 10mg tablet (ages 8-21 years); 1 time dose given per oral at the start of the study day.

DRUG

Atorvastatin

Atorvastatin 10mg tablet (ages 8-21 years); 1 time dose given per oral at the start of the study day.

Sponsors & Collaborators

  • Children's Mercy Hospital Kansas City

    lead OTHER

Principal Investigators

  • Jon B Wagner, DO · Children's Mercy Hospital Kansas City

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
8 Years
Max Age
21 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2014-07-31
Primary Completion
2017-12-27
Completion
2017-12-27

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02364258 on ClinicalTrials.gov