Efficacy and Safety of the Pediatric Formulation of Artemether- Lumefantrine in Children With Uncomplicated P. Falciparum Malaria.
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|ClinicalTrials.gov Identifier: NCT00386763|
Recruitment Status : Completed
First Posted : October 12, 2006
Last Update Posted : March 12, 2009
|Condition or disease||Intervention/treatment||Phase|
|Malaria Falciparum||Drug: Artemether-lumefantrine||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Enrollment :||890 participants|
|Intervention Model:||Parallel Assignment|
|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.|
|Study Start Date :||August 2006|
|Study Completion Date :||March 2007|
- Proportion of patients free of parasites at day 28.
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00386763
|Study Chair:||Novartis Pharmaceuticals||Novartis Pharmaceuticals|