Ignite Creation Date:
2025-12-25 @ 2:03 AM
Ignite Modification Date:
2026-03-15 @ 3:25 AM
Study NCT ID:
NCT00526760
Status:
COMPLETED
Last Update Posted:
2015-06-30
First Post:
2007-09-05
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Long-term Clinical Study Evaluating the Safety and Efficacy of Dexmedetomidine in ICU Subjects
Sponsor:
Hospira, now a wholly owned subsidiary of Pfizer
Organization:
Study Overview
Official Title:
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
Status Verified Date:
2015-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: