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Clinical Trial Summary

Primary Objective:

To assess the antiparasitic activity of intramuscular (IM) SAR97276A based on parasite reduction ratio at 72 hours in pediatric patients with uncomplicated malaria

Secondary Objectives:

- To assess the evolution of clinical signs and symptoms (including the need for a rescue therapy) in pediatric patients with uncomplicated malaria receiving SAR97276A with reference to Artemisinin-Based Combination Therapy (ACTs)

- To assess the pharmacokinetics profile of SAR97276A in pediatric patients with uncomplicated malaria

- To assess the safety profile of SAR97276A in pediatric patients with uncomplicated malaria

- To assess the pharmacokinetic-pharmacodynamic relationship of SAR97276A


Clinical Trial Description

The total duration per patients will last approximately 28 ± 2 days broken down as follows:

- A screening phase up to 12-hours

- A 28 ± 2 days study period ;


Study Design

Allocation: Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


NCT number NCT01445938
Study type Interventional
Source Sanofi
Contact
Status Terminated
Phase Phase 2
Start date October 2011
Completion date January 2012

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