Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00709969 | Evaluation of Safety and Efficacy of Artemether-Lumefantrine Tablets in African Infants and Children With Uncomplicated P. Falciparum Malaria | PHASE3 | COMPLETED | 310 | — | — | Jul 1, 2002 | Feb 1, 2003 | Jul 3, 2008 | 3 | Kenya, Nigeria +1 |
| Arm | Type | Description |
|---|---|---|
| 1 | EXPERIMENTAL | Artemether-lumefantrine |
| Name | Type | Description |
|---|---|---|
| Artemether-lumefantrine | DRUG | 20mg artemether and 120 mg lumefantrine, tablet, dose based on body weight, 3 days treatment 5 - \< 10kg (BWG 1) = 6 doses of 1 tablet / 10 - \< 15kg (BWG 2) = 6 doses of 1 tablet / 15 - ≤ 25kg (BWG 3) = 6 doses of 2 tablets |
Inclusion Criteria: * male or female weighing ≥ 5kg and ≤ 25kg * P. falciparum parasitemia between 1,000 and 100,000 parasites/mm3 * with confirmed diagnosis of uncomplicated malaria caused P. falciparum parasite Exclusion Criteria: * complicated malaria * ingestion of various antimalarial drugs,...