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RECRUITING

Pharmacokinetics, Pharmacodynamics, and Safety Profile of Understudied Drugs Administered to Children Per Standard of Care (POPS)

NCT04278404 · View on ClinicalTrials.gov ↗

Study Summary

The study investigators are interested in learning more about how drugs, that are given to children by their health care provider, act in the bodies of children and young adults in hopes to find the most safe and effective dose for children. The primary objective of this study is to evaluate the PK of understudied drugs currently being administered to children per SOC as prescribed by their treating provider.

Interventions

  • DRUG The POP02 study is collecting bodily fluid samples (i.e., whole blood, effluent samples) of children prescribed the following drugs of interest per standard of care:

Study Locations (20)

California

  • University of California, Los Angeles Medical Center — Los Angeles
  • Lucile Packard Children's Hospital — Palo Alto

Colorado

  • Colorado University Denver — Aurora
  • The Children's Hospital Colorado — Aurora

Illinois

  • Ann and Robert H. Lurie Childrens Hospital of Chicago — Chicago
  • Ann and Robert H. Lurie Childrens Hospital of Chicago — Chicago

Louisiana

  • Tulane University Health Science Center — New Orleans
  • Ochsner Baptist Clinical Trials Unit — New Orleans

Massachusetts

  • Boston Children's Hospital — Boston
  • Massachusetts General Hospital — Lexington

Arizona

  • Phoenix Children's Hospital — Phoenix

Arkansas

  • Arkansas Children's Hospital Research Institute — Little Rock

Delaware

  • Alfred I. DuPont Hospital for Children — Wilmington

Trial Details

FieldValue
Enrollment Target 5,000 participants
Start Date 2020-03-05
Est. Completion 2027-09

Sponsor

Duke University

1,129 total trials

Interested in This Trial?

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT04278404

The ClinicalTrials.gov registry entry for NCT04278404 describes a study currently listed as recruiting. It is categorized as an unspecified phase, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 5,000 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Duke University, which has 1,129 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 10 conditions, with Hypertension appearing as the primary indexed condition, and to 1 intervention — of which The POP02 study is collecting bodily fluid samples (i.e., whole blood, effluent samples) of children prescribed the following drugs of interest per standard of care: is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT04278404 reports 20 study locations spanning 15 distinct geographic areas — top geographies include California, Colorado, Illinois. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT04278404 about?

NCT04278404 is a clinical study titled "Pharmacokinetics, Pharmacodynamics, and Safety Profile of Understudied Drugs Administered to Children Per Standard of Care (POPS)". The study investigators are interested in learning more about how drugs, that are given to children by their health care provider, act in the bodies of children and young adults in hopes to find the most safe and effective dose for children. The primary objective of this study is to evaluate the PK ...

What is the current status of trial NCT04278404?

This trial is currently recruiting. The enrollment target is 5,000 participants. The study started on 2020-03-05. Estimated completion is 2027-09.

What conditions does trial NCT04278404 study?

This clinical trial studies the following conditions: Hypertension, Heart Failure, Pain, Pulmonary Arterial Hypertension, Edema. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT04278404?

The interventions under investigation include: The POP02 study is collecting bodily fluid samples (i.e., whole blood, effluent samples) of children prescribed the following drugs of interest per standard of care: (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT04278404?

This trial is sponsored by Duke University, which has 1,129 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT04278404 being conducted?

This trial has 20 study locations across Arizona, Arkansas, California, Colorado, Delaware. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial