Trials / Completed
CompletedNCT00386763
Efficacy and Safety of the Pediatric Formulation of Artemether- Lumefantrine in Children With Uncomplicated P. Falciparum Malaria.
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
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 890 (planned)
- Sponsor
- Novartis · Industry
- Sex
- All
- Age
- 12 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Artemether-lumefantrine |
Timeline
- Start date
- 2006-08-01
- Completion
- 2007-03-01
- First posted
- 2006-10-12
- Last updated
- 2009-03-12
Locations
5 sites across 5 countries: Benin, Kenya, Mali, Mozambique, Tanzania
Source: ClinicalTrials.gov record NCT00386763. Inclusion in this directory is not an endorsement.