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Clinical trials for Artemether

The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
  • clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

    • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).

    The EU Clinical Trials Register currently displays   44335   clinical trials with a EudraCT protocol, of which   7366   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
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    8 result(s) found for: Artemether. Displaying page 1 of 1.
    EudraCT Number: 2011-005852-33 Sponsor Protocol Number: CCOA566B2306 Start Date*: 2016-04-11
    Sponsor Name:Novartis Pharma AG
    Full Title: An open-label, single-arm study to evaluate the efficacy, safety and PK of artemether-lumefantrine Dispersible Tablet in the treatment of acute uncomplicated Plasmodium falciparum malaria in infant...
    Medical condition: The purpose of the study is to obtain efficacy, safety and pharmacokinetic (PK) data following treatment with artemether-lumefantrine dispersible tablet in infants < 5 kg of body weight (BW) with u...
    Disease: Version SOC Term Classification Code Term Level
    18.1 10021881 - Infections and infestations 10025487 Malaria PT
    Population Age: Newborns, Infants and toddlers, Under 18 Gender: Male, Female
    Trial protocol: Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2016-004321-16 Sponsor Protocol Number: CCOA566A2417 Start Date*: 2017-08-31
    Sponsor Name:Novartis Pharma AG
    Full Title: A study of the effects of Coartem, Malarone and artesunate-mefloquine on auditory function in patients 12 years of age or older with acute uncomplicated P. falciparum malaria
    Medical condition: This study assessed the effects of artemether-lumefantrine on the auditory nerve pathway as assessed by Auditory Brainstem Response (ABR) and audiometric testing in acute uncomplicated Plasmodium f...
    Disease:
    Population Age: Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2023-000804-21 Sponsor Protocol Number: CCOA566B2307 Start Date*: 2024-07-29
    Sponsor Name:Novartis Pharma AG
    Full Title: Multicenter, Open-label, Single-arm Study to Evaluate the PK, Safety, Tolerability and Efficacy of a New Artemether:Lumefantrine (2.5 mg:30 mg) Dispersible Tablet in the Treatment of Infants and Ne...
    Medical condition: Plasmodium Falciparum Malaria
    Disease: Version SOC Term Classification Code Term Level
    20.0 10021881 - Infections and infestations 10021881 Infections and infestations SOC
    20.1 10021881 - Infections and infestations 10035500 Plasmodium falciparum infection PT
    21.1 10021881 - Infections and infestations 10016171 Falciparum malaria LLT
    Population Age: Newborns, Infants and toddlers, Under 18 Gender: Male, Female
    Trial protocol: Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2012-001333-14 Sponsor Protocol Number: CCOA566B2303 Start Date*: 2012-03-09
    Sponsor Name:Novartis Pharma AG
    Full Title: A randomized, investigator-blinded, multicenter, parallel group study to compare efficacy, safety and tolerability of Coartem® dispersible tablet formulation vs. Coartem® 6-dose crushed tablet in t...
    Medical condition: This study will evaluate the safety and efficacy of artemether-lumefantrine against uncomplicated malaria caused by Plasmodium falciparum in children.
    Disease: Version SOC Term Classification Code Term Level
    14.1 10021881 - Infections and infestations 10025487 Malaria PT
    Population Age: Infants and toddlers, Children, Under 18 Gender: Male, Female
    Trial protocol: Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2014-004163-21 Sponsor Protocol Number: A0661157 Start Date*: 2015-04-06
    Sponsor Name:Pfizer Inc
    Full Title: Phase 2/3, Open-Label, Comparative Trial Of Azithromycin Plus Chloroquine Versus Artemether-Lumefantrine For The Treatment Of Uncomplicated Plasmodium Falciparum Malaria In Children In Africa
    Medical condition: Malaria
    Disease: Version SOC Term Classification Code Term Level
    17.1 10021881 - Infections and infestations 10025487 Malaria PT
    Population Age: Infants and toddlers, Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2015-004461-85 Sponsor Protocol Number: CCOA556B2401 Start Date*: 2016-04-06
    Sponsor Name:Novartis Pharma AG
    Full Title: A cluster randomized, single-centre, controlled, parallel,12-month prospective study and additional 12-month follow-up in Africa of malaria incidence in a community setting following systematic tre...
    Medical condition: This study assessed the impact of the systematic detection by Rapid Diagnostic Test (RDT) and treatment of asymptomatic carriers of malaria parasites (P. falciparum) with COA566 on the number of cl...
    Disease: Version SOC Term Classification Code Term Level
    18.1 10021881 - Infections and infestations 10025487 Malaria PT
    Population Age: Infants and toddlers, Children, Adolescents, Under 18, Adults, Elderly Gender: Male, Female
    Trial protocol: Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2014-005510-34 Sponsor Protocol Number: MMV_DSM265_14_01 Start Date*: 2015-09-30
    Sponsor Name:Medicines for Malaria Venture
    Full Title: Evaluation of the prophylactic antimalarial activity of a single dose of DSM265 in non-immune healthy adult volunteers by controlled human malaria infection with PfSPZ Challenge
    Medical condition: Healthy volunteers; controlled human malaria infection with PfSPZ
    Disease: Version SOC Term Classification Code Term Level
    18.1 10042613 - Surgical and medical procedures 10025494 Malaria prophylaxis PT
    Population Age: Adults Gender: Male, Female
    Trial protocol: DE (Completed)
    Trial results: (No results available)
    EudraCT Number: 2020-003284-25 Sponsor Protocol Number: CKAF156A2202 Start Date*: 2021-02-18
    Sponsor Name:Novartis Pharma AG
    Full Title: A Phase 2 interventional, multicenter, randomized open-label study to determine the effective and tolerable dose of KAF156 and Lumefantrine Solid Dispersion Formulation in combination, given once d...
    Medical condition: Uncomplicated Plasmodium falciparum malaria
    Disease: Version SOC Term Classification Code Term Level
    20.1 10021881 - Infections and infestations 10035500 Plasmodium falciparum infection PT
    21.1 10021881 - Infections and infestations 10016171 Falciparum malaria LLT
    Population Age: Children, Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: Outside EU/EEA
    Trial results: View results
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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