Ignite Creation Date:
2024-05-05 @ 5:15 PM
Last Modification Date:
2024-10-26 @ 9:30 AM
Study NCT ID:
NCT00423267
Status:
COMPLETED
Last Update Posted:
2017-04-11
First Post:
2007-01-17
Brief Title:
POS vs FLU for First Line Treatment of Coccidioidomycosis Study P04558Am1COMPLETED
Sponsor:
Merck Sharp Dohme LLC
Organization:
Merck Sharp Dohme LLC
Study Overview
Official Title:
A Multicenter Randomized Controlled Double-Blind Double-Dummy Two-Arm Study of Posaconazole vs Fluconazole in the Treatment of Coccidioidomycosis
Status:
COMPLETED
Status Verified Date:
2017-03
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 evaluate the safety of posaconazole POS in the treatment of coccidioidomycosis Period A consisted of 2 blinded arms posaconazole and fluconazole Recruitment was stopped and participants in Period A may have been eligible to roll over to an open-label non-comparitive Period B During Period B participants received posaconazole for a treatment duration not to exceed 12 months
Detailed Description:
None
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