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Safety, Tolerability, Pharmacokinetics and Efficacy of ARCO

Malaria, Falciparum Clinical Trial

Official title:
Safety, Tolerability, Pharmacokinetics and Efficacy, Phase Iv, Open Label Study of Fixed Arco® and Eurartesim® Therapies in Adults and Children With Uncomplicated P. Falciparum Malaria in Tanzania

Clinical Trial Summary

Phase IV, single center, 2 arms randomized controlled, open label study. Study will be conducted over a period of 42 days to determine the safety, tolerability, pharmacokinetics and efficacy of ARCO.

Clinical Trial Description

Evaluation of safety and tolerability of the administration of ARCO and Eurartesim in terms of blood biochemistry, full blood count, ECG assessments, vital signs and adverse events profile in patients with uncomplicated P. falciparum malaria. Dihydroartemisinin/piperaquine will be used as comparator. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT01930331
Study type Interventional
Source Ifakara Health Institute
Contact
Status Completed
Phase Phase 4
Start date January 7, 2014
Completion date June 1, 2015
View Details
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