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Completed Phase 1 Interventional Accepts healthy volunteers

Pharmacokinetics of Rosuvastatin and Atorvastatin in Pediatric Dyslipidemia Patients

ClinicalTrials.gov ID: NCT02364258

Public ClinicalTrials.gov record NCT02364258. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

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Official title

Pharmacokinetics of Rosuvastatin and Atorvastatin in Pediatric Dyslipidemia Patients: Clinical Impact of Genetic Variation in Statin Disposition

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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.

Study identification

NCT ID
NCT02364258
Recruitment status
Completed
Study type
Interventional
Phase
Phase 1
Enrollment
28 participants

Conditions and interventions

Conditions

Interventions

Drug

Eligibility (public fields only)

Age range
8 Years to 21 Years
Sex
All
Healthy volunteers
Accepts healthy volunteers

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Jul 2014 (Type not available)
Primary completion
Dec 27, 2017 (Actual)
Completion
Dec 27, 2017 (Actual)
Last update posted
Jan 31, 2019

2014 – 2017

United States locations

U.S. sites
1
U.S. states
1
U.S. cities
1
Facility City State ZIP Site status
Children's Mercy Hospital Kansas City Missouri 64108 —

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT02364258, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Jan 31, 2019 · Synced Nov 9, 2026

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Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT02364258 live on ClinicalTrials.gov.

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