Ignite Creation Date:
2024-05-05 @ 5:23 PM
Last Modification Date:
2024-10-26 @ 9:31 AM
Study NCT ID:
NCT00445796
Status:
COMPLETED
Last Update Posted:
2008-04-10
First Post:
2007-03-08
Brief Title:
Arsucam Artesunate Amiodaquine Efficacy and TOLerance
Sponsor:
Sanofi
Organization:
Sanofi
Study Overview
Official Title:
Randomised Comparative Study of the Efficacy and Safety of Arsucam Administered as a Single Daily Intake Versus Two Daily Intakes in the Treatment of Plasmodium Falciparum Malaria Attack
Status:
COMPLETED
Status Verified Date:
2008-04
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:
ATOL
Brief Summary:
Primary Objective
To demonstrate the non-inferiority in terms of clinical and parasitological efficacy on Day 14 of administration of Arsucam as a single daily intake versus two daily intakes
Secondary Objective
To compare the clinical safety of the two treatment regimens
To demonstrate the non-inferiority in terms of clinical and parasitological efficacy on Day 14 of administration of Arsucam as a single daily intake versus two daily intakes
Secondary Objective
To compare the clinical safety of the two treatment regimens
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