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NCT02364258 · ClinicalTrials.gov registry record · Phase 1
Pharmacokinetics of Rosuvastatin and Atorvastatin in Pediatric Dyslipidemia Patients
A Phase 1 study, sponsored by Children's Mercy Hospital Kansas City.
- Completed
- Registry status
- Phase 1
- Development phase
- 28
- Enrollment target
NCT02364258 is a Phase 1 study that has completed, run by Children's Mercy Hospital Kansas City. The registered enrollment target is 28 participants.
The verdict
NCT02364258, a Phase 1 study, has completed, sponsored by Children's Mercy Hospital Kansas City.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 28 participants
- Enrollment target
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.
Interventions
- DRUG Rosuvastatin
- DRUG Atorvastatin
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 28 participants |
| Start Date | 2014-07 |
| Est. Completion | 2017-12-27 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02364258
The ClinicalTrials.gov registry entry for NCT02364258 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 28 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Children's Mercy Hospital Kansas City, which has 184 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Rosuvastatin is the first listed.
NCT02364258 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02364258 about?
NCT02364258 is a clinical study titled "Pharmacokinetics of Rosuvastatin and Atorvastatin in Pediatric Dyslipidemia Patients". 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/w...
What is the current status of trial NCT02364258?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 28 participants. The study started on 2014-07. Estimated completion is 2017-12-27.
What interventions are being tested in trial NCT02364258?
The interventions under investigation include: Rosuvastatin (DRUG), Atorvastatin (DRUG).
Who is sponsoring clinical trial NCT02364258?
This trial is sponsored by Children's Mercy Hospital Kansas City, which has 184 total clinical trials registered on ClinicalTrials.gov.
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