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NCT00652028 · ClinicalTrials.gov registry record · Phase 2

Pharmacokinetics and Pharmacodynamics of Dexmedetomidine in Pediatrics Subjects

A Phase 2 study of Intubated and Mechanically Ventilated Pediatric Subjects, sponsored by Hospira, now a wholly owned subsidiary of Pfizer.

Completed
Registry status
Phase 2
Development phase
69
Enrollment target
9
Study locations

NCT00652028: Completed Phase 2 study of Intubated and Mechanically Ventilated Pediatric Subjects, sponsored by Hospira, now a wholly owned subsidiary of Pfizer.

NCT00652028 is a Phase 2 study of Intubated and Mechanically Ventilated Pediatric Subjects that has completed, run by Hospira, now a wholly owned subsidiary of Pfizer. The registered enrollment target is 69 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (48% lower). The trial reports 9 study locations across 8 states. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00652028, a Phase 2 study of Intubated and Mechanically Ventilated Pediatric Subjects, has completed, sponsored by Hospira, now a wholly owned subsidiary of Pfizer.

COMPLETED
Registry status
Phase 2
Development phase
69 participants
Enrollment target
9
Study locations

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.

Primary Outcome

Area under the concentration-time curve from time zero to the time of the last measurable concentration (AUC0-t) for Dexmedetomidine

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

What the finished NCT00652028 record still lists

NCT00652028 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 69 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (48% lower).

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.

NCT00652028 lists 9 locations in 8 states (Pennsylvania, Florida, Kentucky).

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.

What interventions are being tested in trial NCT00652028?

The interventions under investigation include: Dexmedetomidine, midazolam; fentanyl (DRUG).

Who is sponsoring clinical trial NCT00652028?

This trial is sponsored by Hospira, now a wholly owned subsidiary of Pfizer, which has 15 total clinical trials registered on ClinicalTrials.gov.

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.

How this trial's enrollment target compares

Where NCT00652028's enrollment target sits among peer trials

69 965th of 2000 higher than 1,034 of 2,000 other Phase 2 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT00652028, the US trial registry maintained by the National Library of Medicine. NCT00652028 (small enrollment · multi site footprint · completed) retrieved and formatted by PlainTrial, see methodology.