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Sponsored by: |
Sanofi-Aventis |
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Information provided by: | Sanofi-Aventis |
ClinicalTrials.gov Identifier: | NCT00316329 |
Primary Objective:
Secondary Objectives:
To compare the 3 treatment groups in terms of:
Condition | Intervention | Phase |
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Malaria |
Drug: Artesunate + Amodiaquine |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Single Blind, Active Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Multinational, Randomized, Comparative Study of the Efficacy and Safety of Three Therapeutic Regimens: Coarsucam™ (Artesunate + Amodiaquine Fixed-Dose Combination) Administered in 1 or 2 Intakes Per Day Versus Coartem® (Artemether + Lumefantrine) in the Treatment of Uncomplicated Plasmodium Falciparum Malaria |
Estimated Enrollment: | 1032 |
Study Start Date: | March 2006 |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion criteria:
Exclusion criteria:
erythromycin, ketoconazole, itraconazole, cimetidine, HIV protease inhibitors)
The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Cameroon | |
CHU | |
Yaounde, Cameroon | |
Madagascar | |
Centre de santé | |
Tsiroanomandidy, Madagascar | |
Mali | |
Bancoumana, Mali | |
Senegal | |
Oussouye, Senegal | |
Keur Socé, Senegal |
Study Director: | Valérie Lameyre | Sanofi-Aventis |
Study ID Numbers: | PM_L_0164 |
Study First Received: | April 18, 2006 |
Last Updated: | April 21, 2008 |
ClinicalTrials.gov Identifier: | NCT00316329 History of Changes |
Health Authority: | Cameroon: Ministry of Public Health |
Benflumetol Artesunate Antimalarials Artemether-lumefantrine combination Protozoan Infections |
Amodiaquine Parasitic Diseases Malaria Artemether Malaria, Falciparum |
Artesunate Protozoan Infections Anti-Infective Agents Amodiaquine Antiprotozoal Agents Coccidiosis Malaria |
Pharmacologic Actions Malaria, Falciparum Antimalarials Antiparasitic Agents Therapeutic Uses Parasitic Diseases Amebicides |