MedTrace Logo

Phase II Pharmacokinetic and Pharmacodynamic Study of DEX in Subjects Aged 12 Months Through <24 Months

NCT01378988 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 5

Last updated 2015-07-24

Study results available
· View outcomes & findings →

Summary

The purpose of this study is to investigate the pharmacokinetic, pharmacodynamic, and safety of dexmedetomidine at 2 different dose levels in pediatric subjects, aged 12 months through \<24 months, administered as an intravenous loading dose followed by continuous infusion for a minimum of 6 hours and up to 24 hours in an intensive care setting.

Conditions

Interventions

DRUG

Dexmedetomidine

For sedation according to protocol

Sponsors & Collaborators

  • Hospira, now a wholly owned subsidiary of Pfizer

    lead INDUSTRY

Principal Investigators

  • Constantinos Chrysostomou, MD · Children's Hospital of Pittusburgh of UPMC

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
12 Months
Max Age
23 Months
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-06-30
Primary Completion
2011-08-31
Completion
2011-08-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01378988 on ClinicalTrials.gov