A Phase IIIb/IV comparative, randomised, multi-centre, open label, parallel 3-arm clinical study to assess the safety and efficacy of repeated administration of ACT therapy (pyronaridine-artesunate or dihydroartemisinin-piperaquine will be compared to either artesunate-amodiaquine or artemether-lumefantrine)

Trial Profile

A Phase IIIb/IV comparative, randomised, multi-centre, open label, parallel 3-arm clinical study to assess the safety and efficacy of repeated administration of ACT therapy (pyronaridine-artesunate or dihydroartemisinin-piperaquine will be compared to either artesunate-amodiaquine or artemether-lumefantrine)

Completed
Phase of Trial: Phase III/IV

Latest Information Update: 03 Apr 2018

At a glance

  • Drugs Artesunate/pyronaridine (Primary) ; Dihydroartemisinin/piperaquine (Primary)
  • Indications Malaria
  • Focus Adverse reactions; Therapeutic Use
  • Acronyms WANECAM-EDCTP
  • Most Recent Events

    • 03 Apr 2018 Status changed from recruiting to completed, according to results published in the Internet Document.
    • 03 Apr 2018 Primary endpoint (the unadjusted and PCR-adjusted adequate clinical and parasitological response (ACPR) for P falciparum and unadjusted ACPR for other Plasmodium species (ie, P ovale and P malariae) at days 28 and 42) has been met, according to results published in the Internet Document.
    • 03 Apr 2018 Primary endpoint (The incidence rate of malaria and repeated treatment safety over 2 years) has been met, according to results published in the Internet Document.
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