A Phase III Comparative (Double-blind, Double-dummy) Randomised, Multi-centre Study to Assess the Efficacy of Pyronaridine Artesunate (180:60mg) Versus Coartem® (Artemether Lumefantrine) in Children & Adult Patients With Falciparum Malaria

NCT00422084 Phase 3 COMPLETED Results posted

The primary objective of this phase III study is to compare the efficacy and safety of the fixed combination of pyronaridine artesunate (Pyramax®, PA) with that of Coartem® (artemether lumefantrine, AL) in children and adults with uncomplicated P falciparum malaria in Africa and South East Asia.

Details

Lead sponsor	Medicines for Malaria Venture
Phase	Phase 3
Status	COMPLETED
Enrolment	1272
Start date	2007-01
Completion	2008-05

Conditions

• Malaria

Interventions

• Pyronaridine artesunate
• Coartem® (artemether lumefantrine)

Primary outcomes

• PCR-Corrected Adequate Clinical and Parasitological Response (ACPR) Rate on Day 28 — Day 28
  Percentage of subjects with PCR-corrected adequate clinical and parasitological response (ACPR) on Day 28, defined as absence of parasitaemia on Day 28 without the subject's meeting any of the criteria of early treatment failure, late clinical failure, or late parasitological failure.

Countries

Democratic Republic of the Congo, Ghana, Indonesia, Kenya, Mali, Mozambique, Philippines, Senegal, The Gambia