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Last Updated: November 5, 2024

CLINICAL TRIALS PROFILE FOR ARTEMETHER; LUMEFANTRINE


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505(b)(2) Clinical Trials for ARTEMETHER; LUMEFANTRINE

This table shows clinical trials for potential 505(b)(2) applications. See the next table for all clinical trials
Trial Type Trial ID Title Status Sponsor Phase Start Date Summary
New Combination NCT00203801 ↗ Combination Antimalarials in Uncomplicated Malaria Completed Global Fund N/A 2002-01-01 The purpose of this study is to study the efficacy of sulfadoxine-pyrimethamine on its own and compare this with efficacy of a new combination antimalarial therapy, either sulphadoxine-pyrimethamine plus artesunate or artemether-lumefantrine.
New Combination NCT00203801 ↗ Combination Antimalarials in Uncomplicated Malaria Completed Medical Research Council, South Africa N/A 2002-01-01 The purpose of this study is to study the efficacy of sulfadoxine-pyrimethamine on its own and compare this with efficacy of a new combination antimalarial therapy, either sulphadoxine-pyrimethamine plus artesunate or artemether-lumefantrine.
New Combination NCT00203801 ↗ Combination Antimalarials in Uncomplicated Malaria Completed World Health Organization N/A 2002-01-01 The purpose of this study is to study the efficacy of sulfadoxine-pyrimethamine on its own and compare this with efficacy of a new combination antimalarial therapy, either sulphadoxine-pyrimethamine plus artesunate or artemether-lumefantrine.
>Trial Type >Trial ID >Title >Status >Phase >Start Date >Summary

All Clinical Trials for ARTEMETHER; LUMEFANTRINE

Trial ID Title Status Sponsor Phase Start Date Summary
NCT00118794 ↗ Lapdap and Coartemether for Uncomplicated Malaria Completed Medical Research Council Phase 3 2004-09-01 Lapdap (chlorproguanil-dapsone) is an affordable and effective drug, but patients with glucose-6-phosphate dehydrogenase (G6PD) A- deficiency are more susceptible to the haemolytic effects of the dapsone component of Lapdap; therefore there is a need to evaluate the extent to which the risks associated with the use of the drug in settings without G6PD screening might outweigh the benefits to malaria treatment. The investigators will evaluate, in operational settings, the safety and effectiveness of Lapdap and coartemether (lumefantrine-artemether) for treatment of uncomplicated malaria in patients 6 months to 10 years of age.
NCT00118794 ↗ Lapdap and Coartemether for Uncomplicated Malaria Completed National Malaria Control Programme, The Gambia Phase 3 2004-09-01 Lapdap (chlorproguanil-dapsone) is an affordable and effective drug, but patients with glucose-6-phosphate dehydrogenase (G6PD) A- deficiency are more susceptible to the haemolytic effects of the dapsone component of Lapdap; therefore there is a need to evaluate the extent to which the risks associated with the use of the drug in settings without G6PD screening might outweigh the benefits to malaria treatment. The investigators will evaluate, in operational settings, the safety and effectiveness of Lapdap and coartemether (lumefantrine-artemether) for treatment of uncomplicated malaria in patients 6 months to 10 years of age.
NCT00118794 ↗ Lapdap and Coartemether for Uncomplicated Malaria Completed London School of Hygiene and Tropical Medicine Phase 3 2004-09-01 Lapdap (chlorproguanil-dapsone) is an affordable and effective drug, but patients with glucose-6-phosphate dehydrogenase (G6PD) A- deficiency are more susceptible to the haemolytic effects of the dapsone component of Lapdap; therefore there is a need to evaluate the extent to which the risks associated with the use of the drug in settings without G6PD screening might outweigh the benefits to malaria treatment. The investigators will evaluate, in operational settings, the safety and effectiveness of Lapdap and coartemether (lumefantrine-artemether) for treatment of uncomplicated malaria in patients 6 months to 10 years of age.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for ARTEMETHER; LUMEFANTRINE

Condition Name

Condition Name for ARTEMETHER; LUMEFANTRINE
Intervention Trials
Malaria 96
Malaria, Falciparum 14
Malaria,Falciparum 11
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Condition MeSH

Condition MeSH for ARTEMETHER; LUMEFANTRINE
Intervention Trials
Malaria 165
Malaria, Falciparum 66
HIV Infections 9
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Clinical Trial Locations for ARTEMETHER; LUMEFANTRINE

Trials by Country

Trials by Country for ARTEMETHER; LUMEFANTRINE
Location Trials
Tanzania 28
Congo, The Democratic Republic of the 27
Kenya 25
Mozambique 22
Burkina Faso 17
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Trials by US State

Trials by US State for ARTEMETHER; LUMEFANTRINE
Location Trials
California 2
Maryland 1
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Clinical Trial Progress for ARTEMETHER; LUMEFANTRINE

Clinical Trial Phase

Clinical Trial Phase for ARTEMETHER; LUMEFANTRINE
Clinical Trial Phase Trials
Phase 4 75
Phase 3 41
Phase 2/Phase 3 12
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Clinical Trial Status

Clinical Trial Status for ARTEMETHER; LUMEFANTRINE
Clinical Trial Phase Trials
Completed 124
Not yet recruiting 15
Unknown status 14
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Clinical Trial Sponsors for ARTEMETHER; LUMEFANTRINE

Sponsor Name

Sponsor Name for ARTEMETHER; LUMEFANTRINE
Sponsor Trials
London School of Hygiene and Tropical Medicine 26
Centers for Disease Control and Prevention 20
University of Oxford 18
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Sponsor Type

Sponsor Type for ARTEMETHER; LUMEFANTRINE
Sponsor Trials
Other 419
Industry 34
U.S. Fed 31
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