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Sponsored by: |
Sanofi-Aventis |
---|---|
Information provided by: | Sanofi-Aventis |
ClinicalTrials.gov Identifier: | NCT00563914 |
The primary objective is to assess the safety of different doses of ferroquine with artesunate (AS) in adult African patients with uncomplicated malaria.
The secondary objectives are to assess activity in reducing parasitemia and the pharmacokinetics of ferroquine and its metabolites.
Condition | Intervention | Phase |
---|---|---|
Malaria |
Drug: ferroquine (SSR97193) Drug: amodiaquine |
Phase I Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | An Open Label, 4 Escalating Dose, Randomized Multicentre Study Evaluating the Safety and Activity of Ferroquine Associated With Artesunate Versus a Positive Calibrator (Amodiaquine Associated With Artesunate) in African Adult Patients With Uncomplicated Malaria |
Estimated Enrollment: | 72 |
Study Start Date: | October 2007 |
Study Completion Date: | November 2008 |
Primary Completion Date: | November 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
1: Experimental |
Drug: ferroquine (SSR97193)
associated with artesunate
|
2: Active Comparator |
Drug: amodiaquine
associated with artesunate
|
The study duration is 30 days including a 2 day screening period, a 3 day treatment period with a follow-up period of 25 days. Patients remain hospitalized 4 days.
Ages Eligible for Study: | 18 Years to 65 Years |
Genders Eligible for Study: | Male |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Gabon | |
Sanofi- Aventis Administrative Office | |
Lambaréné, Gabon | |
Kenya | |
Sanofi-Aventis Administrative Office | |
Nairobi, Kenya |
Principal Investigator: | Christian Supan, MD | URM (Unité de Recherches Médicales), Hôpital Albert Schweitzer, BP 118 Lambaréné, Gabon |
Responsible Party: | sanofi-aventis ( ICD Study Director ) |
Study ID Numbers: | ACT10420, SSR97193 |
Study First Received: | November 22, 2007 |
Last Updated: | December 11, 2008 |
ClinicalTrials.gov Identifier: | NCT00563914 |
Health Authority: | Gabon : Comité d'Ethique |
Malaria |
Artesunate Protozoan Infections Amodiaquine Parasitic Diseases Malaria |
Anti-Infective Agents Antimalarials Antiparasitic Agents Antiprotozoal Agents |
Coccidiosis Therapeutic Uses Amebicides Pharmacologic Actions |