Ignite Creation Date:
2024-05-05 @ 5:06 PM
Last Modification Date:
2024-10-26 @ 9:28 AM
Study NCT ID:
NCT00386763
Status:
COMPLETED
Last Update Posted:
2009-03-12
First Post:
2006-10-11
Brief Title:
Efficacy and Safety of the Pediatric Formulation of Artemether- Lumefantrine in Children With Uncomplicated P Falciparum Malaria
Sponsor:
Novartis
Organization:
Novartis
Study Overview
Official Title:
A Randomized Investigator-Blinded Multicenter Parallel-Group Study to Compare Efficacy Safety and Tolerability of Arthemeter Lumefantrine Dispersible Tablet Formulation vs Artemether Lumefantrine 6-Dose Crushed Tablet in the Treatment of Acute Uncomplicated Plasmodium Falciparum Malaria in Infants and Children
Status:
COMPLETED
Status Verified Date:
2009-03
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:
This study will evaluate the safety and efficacy of artemether-lumefantrine against uncomplicated malaria caused P falciparum in children of 5-35 kg bodyweight
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