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A Safety and Efficacy Study of Dexmedetomidine in ICU Patients Requiring Continuous Sedation

NCT00216190 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 420

Last updated 2015-07-23

No results posted yet for this study

Summary

The purpose of this study is to evaluate the safety and efficacy of dexmedetomidine in ICU subjects who are initially intubated, mechanically ventilated and require sedation for beyond 24 hours.

Conditions

  • Mechanically Ventilated and Intubated Subjects

Interventions

DRUG

Dexmedetomidine HCL Injection

DRUG

Midazolam Injection

Sponsors & Collaborators

  • Hospira, now a wholly owned subsidiary of Pfizer

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2005-03-31
Completion
2007-08-31

Countries

  • United States
  • Argentina
  • Australia
  • Brazil
  • New Zealand

Study Locations

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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 NCT00216190 on ClinicalTrials.gov