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Sponsored by: |
Sanofi-Aventis |
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Information provided by: | Sanofi-Aventis |
ClinicalTrials.gov Identifier: | NCT00445796 |
Primary Objective:
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.
Secondary Objective:
To compare the clinical safety of the two treatment regimens.
Condition | Intervention | Phase |
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Malaria |
Drug: Artesunate Drug: Amodiaquine |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Dose Comparison, Parallel Assignment, Safety/Efficacy Study |
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 |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Study ID Numbers: | PM_L_0163 |
Study First Received: | March 8, 2007 |
Last Updated: | April 8, 2008 |
ClinicalTrials.gov Identifier: | NCT00445796 |
Health Authority: | Senegal: Ministere de la sante |
Artesunate Protozoan Infections Amodiaquine |
Parasitic Diseases Malaria Malaria, Falciparum |
Anti-Infective Agents Antimalarials Antiparasitic Agents Antiprotozoal Agents |
Coccidiosis Therapeutic Uses Amebicides Pharmacologic Actions |