Efficacy and Safety of the Pediatric Formulation of Artemether- Lumefantrine in Children With Uncomplicated P. Falciparum Malaria.
This study has been completed.
Information provided by:
First received: October 11, 2006
Last updated: March 11, 2009
Last verified: March 2009
This study will evaluate the safety and efficacy of artemether-lumefantrine against uncomplicated malaria caused P. falciparum in children of 5-35 kg bodyweight.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind
Primary Purpose: Treatment
|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.|
Resource links provided by NLM:
U.S. FDA Resources
Further study details as provided by Novartis:
Primary Outcome Measures:
- Proportion of patients free of parasites at day 28.
Secondary Outcome Measures:
- Proportion of patients free of parasites at 7 days and at 14 days
- Time to clearance from parasites
- Time to clearance of fever
- Hematology and biochemistry parameters
|Study Start Date:||August 2006|
|Estimated Study Completion Date:||March 2007|
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00386763
Sponsors and Collaborators
|Study Chair:||Novartis Pharmaceuticals||Novartis Pharmaceuticals|