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NCT00576381 · ClinicalTrials.gov registry record · Phase 1

Understanding Dexmedetomidine in Neonates After Open Heart Surgery

A Phase 1 study of Tetrology of Fallot and Heart Ventricle, sponsored by Athena Zuppa.

Completed
Registry status
Phase 1
Development phase
30
Enrollment target
1
Study location

NCT00576381 is a Phase 1 study of Tetrology of Fallot and Heart Ventricle that has completed, run by Athena Zuppa. The registered enrollment target is 30 participants, below the 82-participant average among 3 other Tetrology of Fallot trials with a reported enrollment target (63% lower). The trial reports 1 study location across 1 state.

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The verdict

NCT00576381, a Phase 1 study of Tetrology of Fallot and Heart Ventricle, has completed, sponsored by Athena Zuppa.

COMPLETED
Registry status
Phase 1
Development phase
30 participants
Enrollment target
1
Study location

Study Summary

The purpose of this study is to determine what happens to dexmedetomidine in the body after it has been given to a newborn after heart surgery. We want to learn how long the drug stays in the body, how the drug is metabolized by the body, and how well the medicine works at a particular dose or amount.

Interventions

  • DRUG Dexmedetomidine

Study Locations (1)

Pennsylvania

  • The Children's Hospital of Philadelphia - Philadelphia

Trial Details

FieldValue
Enrollment Target 30 participants
Start Date 2006-04
Est. Completion 2010-12
Phase Phase 1

Sponsor

Athena Zuppa

1 total trials

What the Registry Record Tells You About NCT00576381

The ClinicalTrials.gov registry entry for NCT00576381 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 30 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 82-participant average among 3 other Tetrology of Fallot trials with a reported enrollment target (63% lower). The listed sponsor is Athena Zuppa, which has 1 total studies on file at ClinicalTrials.gov.

The record links to 3 conditions, with Tetrology of Fallot appearing as the primary indexed condition, and to 1 intervention - of which Dexmedetomidine is the first listed.

NCT00576381 reports 1 study location spanning 1 distinct geographic area - top geographies include Pennsylvania.

Frequently Asked Questions

What is clinical trial NCT00576381 about?

NCT00576381 is a clinical study titled "Understanding Dexmedetomidine in Neonates After Open Heart Surgery". The purpose of this study is to determine what happens to dexmedetomidine in the body after it has been given to a newborn after heart surgery. We want to learn how long the drug stays in the body, how the drug is metabolized by the body, and how well the medicine works at a particular dose or amoun...

What is the current status of trial NCT00576381?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 30 participants. The study started on 2006-04. Estimated completion is 2010-12.

What conditions does trial NCT00576381 study?

This clinical trial studies the following conditions: Tetrology of Fallot, Heart Ventricle, Hypoplastic Left Heart.

What interventions are being tested in trial NCT00576381?

The interventions under investigation include: Dexmedetomidine (DRUG).

Who is sponsoring clinical trial NCT00576381?

This trial is sponsored by Athena Zuppa, which has 1 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT00576381 being conducted?

This trial has 1 study location across Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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

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