A Comparative Safety and Activity Study With Ferroquine Associated With Artesunate Versus Amodiaquine Associated With Artesunate in African Adult Patients With Uncomplicated Malaria
NCT00563914 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 72
Last updated 2009-12-21
Summary
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.
Conditions
Interventions
- DRUG
-
ferroquine (SSR97193)
associated with artesunate
- DRUG
-
amodiaquine
associated with artesunate
Sponsors & Collaborators
- lead INDUSTRY
Principal Investigators
-
Christian Supan, MD · URM (Unité de Recherches Médicales), Hôpital Albert Schweitzer, BP 118 Lambaréné, Gabon
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 65 Years
- Sex
- MALE
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2007-10-31
- Primary Completion
- 2008-11-30
- Completion
- 2008-11-30
Countries
- Gabon
- Kenya
Study Locations
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