Ignite Creation Date:
2024-05-05 @ 4:47 PM
Last Modification Date:
2024-10-26 @ 9:24 AM
Study NCT ID:
NCT00316329
Status:
COMPLETED
Last Update Posted:
2008-04-22
First Post:
2006-04-18
Brief Title:
ATAQ EASY Artesunate Amodiaquine Fixed Dose Combination in the Treatment of Uncomplicated Plasmodium Falciparum Malaria
Sponsor:
Sanofi
Organization:
Sanofi
Study Overview
Official Title:
Multinational Randomized Comparative Study of the Efficacy and Safety of Three Therapeutic Regimens Coarsucam Artesunate Amodiaquine Fixed-Dose Combination Administered in 1 or 2 Intakes Per Day Versus Coartem Artemether Lumefantrine in the Treatment of Uncomplicated Plasmodium Falciparum Malaria
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:
None
Brief Summary:
Primary Objective
To demonstrate the non-inferiority in terms of clinical and parasitological efficacy on D28 of administration of Coarsucam artesunateamodiaquine fixed-dose combination as a single daily dose in comparison with administration of Coartem artemetherlumefantrine
Secondary Objectives
To compare the 3 treatment groups in terms of
clinical and parasitological efficacy on D14 and D28 on the global population and on the subpopulation consisting of children aged under 5 years and that for patients aged 5 years and over
clinical and laboratory safety
time to parasite clearance
time to clearance of fever
changes in gametocytaemia
impact on anaemia
To demonstrate the non-inferiority in terms of clinical and parasitological efficacy on D28 of administration of Coarsucam artesunateamodiaquine fixed-dose combination as a single daily dose in comparison with administration of Coartem artemetherlumefantrine
Secondary Objectives
To compare the 3 treatment groups in terms of
clinical and parasitological efficacy on D14 and D28 on the global population and on the subpopulation consisting of children aged under 5 years and that for patients aged 5 years and over
clinical and laboratory safety
time to parasite clearance
time to clearance of fever
changes in gametocytaemia
impact on anaemia
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