NCT00526760

Long-term Clinical Study Evaluating the Safety and Efficacy of Dexmedetomidine in ICU Subjects

A Phase 3, Open-Label Study Evaluating the Safety and Efficacy of Dexmedetomidine in ICU Subjects Requiring Greater Than 24 Hours of Continuous Sedation

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 80 (actual)
• Sponsor: Hospira, now a wholly owned subsidiary of Pfizer · Industry
• Sex: All
• Age: 20 Years
• Healthy volunteers: Not accepted

Summary

Evaluate efficacy and safety of dexmedetomidine long term administration in ICU patients who require more than 24 hours sedation.

Detailed description

According to the current dexmedetomidine indication, the duration of dexmedetomidine administration is limited within 24 hours. However, there is a strong demand from the medical specialists for continued administration of dexmedetomidine in excess of 24 hours in the medical practice because a large number of patients require sedation for more than 24 hours in ICU. To meet such clinical demand, it was planned to conduct a phase III long-term administration study of dexmedetomidine to obtain the approval on the infusion of dexmedetomidine for more than 24 hours.

Conditions

• Sedation

Interventions

Type	Name	Description
DRUG	Dexmedetomidine

Timeline

• Start date: 2007-10-01
• Primary completion: 2008-06-01
• Completion: 2008-06-01
• First posted: 2007-09-10
• Last updated: 2015-06-30

Locations

10 sites across 1 country: Japan