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Last Updated: January 26, 2022

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CLINICAL TRIALS PROFILE FOR AMODIAQUINE HYDROCHLORIDE

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505(b)(2) Clinical Trials for AMODIAQUINE HYDROCHLORIDE

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 NCT05160363 ↗ A Healthy Volunteer Safety Study of Pyronaridine Tetraphosphate Taken in Combination With Piperaquine Tetraphosphate Not yet recruiting PharmaKinetic Ltd Phase 1 2022-01-01 The study is a clinical trial involving two medicines called piperaquine (PQP) and pyronaridine (PYR) which, in combination with dihydroartemisinin (DHA) and with artesunate (ART) respectively, have been in clinical use for over 20 years to treat acute episodes of malaria. PYR and PQP are both known to be well tolerated and provide effective treatment for malarial infection when administered in their licensed combinations, but have not been administered together in combination before. This new combination is being considered for development for malaria prevention (i.e. chemoprophylaxis) in sub-Saharan Africa and therefore, the trial participants will be exclusively drawn from a population from that origin.
New Combination NCT05160363 ↗ A Healthy Volunteer Safety Study of Pyronaridine Tetraphosphate Taken in Combination With Piperaquine Tetraphosphate Not yet recruiting Richmond Pharmacology Limited Phase 1 2022-01-01 The study is a clinical trial involving two medicines called piperaquine (PQP) and pyronaridine (PYR) which, in combination with dihydroartemisinin (DHA) and with artesunate (ART) respectively, have been in clinical use for over 20 years to treat acute episodes of malaria. PYR and PQP are both known to be well tolerated and provide effective treatment for malarial infection when administered in their licensed combinations, but have not been administered together in combination before. This new combination is being considered for development for malaria prevention (i.e. chemoprophylaxis) in sub-Saharan Africa and therefore, the trial participants will be exclusively drawn from a population from that origin.
New Combination NCT05160363 ↗ A Healthy Volunteer Safety Study of Pyronaridine Tetraphosphate Taken in Combination With Piperaquine Tetraphosphate Not yet recruiting Medicines for Malaria Venture Phase 1 2022-01-01 The study is a clinical trial involving two medicines called piperaquine (PQP) and pyronaridine (PYR) which, in combination with dihydroartemisinin (DHA) and with artesunate (ART) respectively, have been in clinical use for over 20 years to treat acute episodes of malaria. PYR and PQP are both known to be well tolerated and provide effective treatment for malarial infection when administered in their licensed combinations, but have not been administered together in combination before. This new combination is being considered for development for malaria prevention (i.e. chemoprophylaxis) in sub-Saharan Africa and therefore, the trial participants will be exclusively drawn from a population from that origin.
>Trial Type >Trial ID >Title >Status >Phase >Start Date >Summary

All Clinical Trials for AMODIAQUINE HYDROCHLORIDE

Trial ID Title Status Sponsor Phase Start Date Summary
NCT00118807 ↗ Trial of the Effectiveness of AQ/AS, SP/AQ and SP/CQ for Uncomplicated Malaria in Gambian Children Completed Medical Research Council Phase 3 2003-08-01 The purpose of this trial is to compare the effectiveness of three combination treatments for uncomplicated malaria when given in operational settings, without supervision of doses other than the first dose.
NCT00118807 ↗ Trial of the Effectiveness of AQ/AS, SP/AQ and SP/CQ for Uncomplicated Malaria in Gambian Children Completed National Malaria Control Programme, The Gambia Phase 3 2003-08-01 The purpose of this trial is to compare the effectiveness of three combination treatments for uncomplicated malaria when given in operational settings, without supervision of doses other than the first dose.
NCT00118807 ↗ Trial of the Effectiveness of AQ/AS, SP/AQ and SP/CQ for Uncomplicated Malaria in Gambian Children Completed London School of Hygiene and Tropical Medicine Phase 3 2003-08-01 The purpose of this trial is to compare the effectiveness of three combination treatments for uncomplicated malaria when given in operational settings, without supervision of doses other than the first dose.
NCT00119132 ↗ Effectiveness of Intermittent Preventive Treatment for Malaria in Children Completed INDEPTH Network Phase 2/Phase 3 2005-06-01 Intermittent preventive treatment for malaria in children (IPTc) is a promising new approach to malaria control. Preliminary studies of IPTc in Senegal and Mali indicate that this approach can be very effective. Although the results of these studies suggest that IPTc with sulphadoxine-pyrimethamine (SP) plus artesunate (AS) or SP alone is an efficacious and safe intervention for reducing the burden of malaria and anaemia in children in high transmission areas with short transmission periods, there is no data from areas with long transmission periods. This study aims to evaluate the effectiveness of IPTc in reducing anaemia and malaria in an area with up to 6 months of transmission in Ghana. Two thousand two hundred forty children aged 3-59 months will be randomly allocated to four groups (560 per arm) to receive amodiaquine plus artesunate (AQ+AS), given at two different intervals (monthly or bimonthly), SP or placebo. The children will also be followed to determine if there is any rebound in the incidence of severe malaria and anaemia in the year following IPTc.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for AMODIAQUINE HYDROCHLORIDE

Condition Name

Condition Name for AMODIAQUINE HYDROCHLORIDE
Intervention Trials
Malaria 67
Malaria, Falciparum 14
Malaria,Falciparum 8
Falciparum Malaria 5
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Condition MeSH

Condition MeSH for AMODIAQUINE HYDROCHLORIDE
Intervention Trials
Malaria 110
Malaria, Falciparum 45
Malaria, Vivax 6
HIV Infections 4
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Clinical Trial Locations for AMODIAQUINE HYDROCHLORIDE

Trials by Country

Trials by Country for AMODIAQUINE HYDROCHLORIDE
Location Trials
Burkina Faso 22
Congo, The Democratic Republic of the 15
Mozambique 13
Ghana 11
Malawi 10
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Trials by US State

Trials by US State for AMODIAQUINE HYDROCHLORIDE
Location Trials
California 1
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Clinical Trial Progress for AMODIAQUINE HYDROCHLORIDE

Clinical Trial Phase

Clinical Trial Phase for AMODIAQUINE HYDROCHLORIDE
Clinical Trial Phase Trials
Phase 4 40
Phase 3 35
Phase 2/Phase 3 7
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Clinical Trial Status

Clinical Trial Status for AMODIAQUINE HYDROCHLORIDE
Clinical Trial Phase Trials
Completed 98
Not yet recruiting 6
Recruiting 5
[disabled in preview] 4
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Clinical Trial Sponsors for AMODIAQUINE HYDROCHLORIDE

Sponsor Name

Sponsor Name for AMODIAQUINE HYDROCHLORIDE
Sponsor Trials
London School of Hygiene and Tropical Medicine 37
Gates Malaria Partnership 13
University of Oxford 10
[disabled in preview] 8
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Sponsor Type

Sponsor Type for AMODIAQUINE HYDROCHLORIDE
Sponsor Trials
Other 306
Industry 15
U.S. Fed 8
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