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COMPLETED Phase 2

Pharmacokinetics and Pharmacodynamics of Dexmedetomidine in Pediatrics Subjects

NCT00652028 · View on ClinicalTrials.gov ↗

Study Summary

The objective of this study is to characterize the pharmacokinetic and pharmacodynamic profile of dexmedetomidine administered as an intravenous loading dose followed by a continuous intravenous infusion in pediatric subjects ages ≥2 through \<17 years old.

Interventions

  • DRUG Dexmedetomidine, midazolam; fentanyl

Study Locations (9)

Pennsylvania

  • Children's Hospital of Philadelphia — Philadelphia
  • Children's Hospital of Pittsburgh — Pittsburgh

Florida

  • Miami Children's Hospital — Miami

Kentucky

  • University of Louisville/Kosair Children's Hospital — Louisville

New York

  • Women and Children's Hospital of Buffalo — Buffalo

North Carolina

  • Duke University Medical Center — Durham

Ohio

  • University Hospitals Medical Center — Cleveland

Virginia

  • Virginia Commonwealth University — Richmond

Other

  • Unidad Cirugia Cardiovascular de Guatemala — Guatemala City

Trial Details

FieldValue
Enrollment Target 69 participants
Start Date 2008-11
Est. Completion 2010-04
Phase Phase 2

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT00652028

The ClinicalTrials.gov registry entry for NCT00652028 describes a study currently listed as completed. It is categorized as Phase 2, 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 69 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Hospira, now a wholly owned subsidiary of Pfizer, which has 3 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 1 condition, with Intubated and Mechanically Ventilated Pediatric Subjects appearing as the primary indexed condition, and to 1 intervention — of which Dexmedetomidine, midazolam; fentanyl 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: NCT00652028 reports 9 study locations spanning 8 distinct geographic areas — top geographies include Pennsylvania, Florida, Kentucky. 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 NCT00652028 about?

NCT00652028 is a clinical study titled "Pharmacokinetics and Pharmacodynamics of Dexmedetomidine in Pediatrics Subjects". The objective of this study is to characterize the pharmacokinetic and pharmacodynamic profile of dexmedetomidine administered as an intravenous loading dose followed by a continuous intravenous infusion in pediatric subjects ages ≥2 through \<17 years old.

What is the current status of trial NCT00652028?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 69 participants. The study started on 2008-11. Estimated completion is 2010-04.

What conditions does trial NCT00652028 study?

This clinical trial studies the following conditions: Intubated and Mechanically Ventilated Pediatric Subjects. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT00652028?

The interventions under investigation include: Dexmedetomidine, midazolam; fentanyl (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT00652028?

This trial is sponsored by Hospira, now a wholly owned subsidiary of Pfizer, which has 3 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT00652028 being conducted?

This trial has 9 study locations across Florida, Kentucky, New York, North Carolina, Ohio. 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