drugset

drugset / Trial / NCT00709969

Evaluation of Safety and Efficacy of Artemether-Lumefantrine Tablets in African Infants and Children With Uncomplicated P. Falciparum Malaria

NCT00709969 ↗

Phase 3 Completed 310 enrolled Novartis Avenue Appia 20 · collab CH - 1211 Geneva 27 · collab Switzerland · collab World Health Organization · collab

NaSingle-groupOpen-labelTreatment

Summary

This study will assess the safety and efficacy of artemether-lumefantrine tablets (6-dose regimen) in African infants / children with acute uncomplicated falciparum malaria.

Timeline

Start: 2002-07
Primary completion: —
Completion: 2003-02

Publications

Falade CO, Ogunkunle OO, Dada-Adegbola HO, Falade AG, de Palacios PI, Hunt P, Virtanen M, Oduola AM, Salako LA. Evaluation of the efficacy and safety of artemether-lumefantrine in the treatment of acute uncomplicated Plasmodium falciparum malaria in Nigerian infants and children. Malar J. 2008 Nov 27;7:246. doi: 10.1186/1475-2875-7-246.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Artemether	Small molecule	20 mg	—
Subject	lumefantrine	Small molecule	120 mg	—

Indications