Ignite Creation Date:
2024-05-05 @ 6:56 PM
Last Modification Date:
2024-10-26 @ 9:38 AM
Study NCT ID:
NCT00575094
Status:
COMPLETED
Last Update Posted:
2011-06-03
First Post:
2007-12-13
Brief Title:
Study Evaluating the Safety and Efficacy of Intravenous Tigecycline to Treat Hospitalized Japanese Subjects
Sponsor:
Wyeth is now a wholly owned subsidiary of Pfizer
Organization:
Wyeth is now a wholly owned subsidiary of Pfizer
Study Overview
Official Title:
A Phase 3 Multicenter Open-label Study Evaluating the Safety and Efficacy of Intravenous Tigecycline to Treat Hospitalized Japanese Subjects With Community-acquired Pneumonia
Status:
COMPLETED
Status Verified Date:
2011-06
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:
To purpose of this study is to assess the safety and tolerability of intravenous IV tigecycline in hospitalized subjects of Japanese descent with community-acquired pneumonia CAP
Detailed Description:
This is a multicenter open-label study evaluating the safety and efficacy of tigecycline in the treatment of Japanese subjects with CAP Subjects with clinical signs and symptoms of CAP who meet the eligibility requirements will be considered for enrollment Qualifying subjects will be assigned to receive tigecycline via IV administration for 7 to 14 consecutive days The exact duration of administration of the study drug will be at the discretion of the investigator based on the subjects condition Subjects will be followed for safety until the test-of-cure TOC assessment 10 to 21 days after the last dose of therapy and for efficacy until TOC assessment
Study Oversight
Has Oversight DMC:
None
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?:
None