Arsucam® (Artesunate + Amiodaquine) Efficacy and TOLerance (ATOL)
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|ClinicalTrials.gov Identifier: NCT00445796|
Recruitment Status : Completed
First Posted : March 9, 2007
Last Update Posted : April 10, 2008
To demonstrate the non-inferiority, in terms of clinical and parasitological efficacy on Day 14, of administration of Arsucam® as a single daily intake versus two daily intakes.
To compare the clinical safety of the two treatment regimens.
|Condition or disease||Intervention/treatment||Phase|
|Malaria||Drug: Artesunate Drug: Amodiaquine||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||300 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Randomised, Comparative Study of the Efficacy and Safety of Arsucam® Administered as a Single Daily Intake Versus Two Daily Intakes in the Treatment of Plasmodium Falciparum Malaria Attack|
|Study Start Date :||June 2005|
- clinical and parasitological cure on Day 14
- Secondary: incidence and severity of adverse events
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00445796
|Study Director:||Valérie Lameyre||Sanofi|