Ignite Creation Date:
2024-05-05 @ 11:52 AM
Last Modification Date:
2024-10-26 @ 9:14 AM
Study NCT ID:
NCT00150319
Status:
TERMINATED
Last Update Posted:
2008-09-29
First Post:
2005-09-06
Brief Title:
An Open-Label Study To Assess The Pharmacokinetics Safety And Toleration Of Vfend Following Multiple Dosing With Vfend
Sponsor:
Pfizer
Organization:
Pfizer
Study Overview
Official Title:
An Open-Label Study To Assess The Pharmacokinetics Safety And Toleration Of Vfend Iv Containing Sbecd As An Excipient Following Multiple Dosing With Vfend IV In Subjects With Moderately Impaired Renal Function
Status:
TERMINATED
Status Verified Date:
2008-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
See Detailed Description
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This is a study to investigate the pharmacokinetics safety and tolerability of intravenous voriconazole and SBECD in patients with moderate renal insufficiency
Detailed Description:
The study was put on hold after the first subject was enrolled and experienced a serious adverse event SAE of renal failure chronic after receiving his IV dose on Day 1 The study was taken off hold after the subject recovered and an independent consultant had deemed the SAE as not treatment related however the site was unwilling to enroll additional subjects Another site based in New Orleans was damaged by hurricane Katrina and was unable to enroll any subjects A decision was made by the sponsor to terminate the study on 11 Apr 2006 due to poor study enrollment There were no safety or efficacy concerns regarding the study in the decision to terminate the trial
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