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NCT01431326 · ClinicalTrials.gov registry record
Pharmacokinetics of Understudied Drugs Administered to Children Per Standard of Care
A clinical trial, sponsored by Daniel Benjamin.
- Completed
- Registry status
- 3,520
- Enrollment target
NCT01431326 is a clinical trial that has completed, run by Daniel Benjamin. The registered enrollment target is 3,520 participants.
The verdict
NCT01431326 has completed, sponsored by Daniel Benjamin.
- COMPLETED
- Registry status
- 3,520 participants
- Enrollment target
Study Summary
Understudied drugs will be administered to children per standard of care as prescribed by their treating caregiver and only biological sample collection during the time of drug administration will be involved. A total of approximately 7000 children aged \<21 years who are receiving these drugs for standard of care will be enrolled and will be followed for up a maximum of 90 days. The goal of this study is to characterize the pharmacokinetics of understudied drugs for which specific dosing recommendations and safety data are lacking. The prescribing of drugs to children will not be part of this protocol. Taking advantage of procedures done as part of routine medical care (i.e. blood draws) this study will serve as a tool to better understand drug exposure in children receiving these drugs per standard of care. The data collected through this initiative will also provide valuable pharmacokinetic and dosing information of drugs in different pediatric age groups as well as special pediatric populations (i.e. obese).
Interventions
- DRUG The POPS study is collecting PK data on children prescribed the following drugs of interest per standard of care:
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 3,520 participants |
| Start Date | 2011-11 |
| Est. Completion | 2019-11 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01431326
The ClinicalTrials.gov registry entry for NCT01431326 describes a study currently listed as completed, categorized as an unspecified phase. The registered enrollment target is 3,520 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Daniel Benjamin, which has 5 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which The POPS study is collecting PK data on children prescribed the following drugs of interest per standard of care: is the first listed.
NCT01431326 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01431326 about?
NCT01431326 is a clinical study titled "Pharmacokinetics of Understudied Drugs Administered to Children Per Standard of Care". Understudied drugs will be administered to children per standard of care as prescribed by their treating caregiver and only biological sample collection during the time of drug administration will be involved. A total of approximately 7000 children aged \<21 years who are receiving these drugs for s...
What is the current status of trial NCT01431326?
This trial is currently completed. The enrollment target is 3,520 participants. The study started on 2011-11. Estimated completion is 2019-11.
What interventions are being tested in trial NCT01431326?
The interventions under investigation include: The POPS study is collecting PK data on children prescribed the following drugs of interest per standard of care: (DRUG).
Who is sponsoring clinical trial NCT01431326?
This trial is sponsored by Daniel Benjamin, which has 5 total clinical trials registered on ClinicalTrials.gov.
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