CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 1,272 enrolled
Drug / intervention
Pyronaridine artesunate +1 moredrug
Likely dose
Pyronaridine artesunate 60mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00422084
NCT00422084Phase 3Completed
CompareCT.gov

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

Medicines for Malaria Venture·interventional·Posted Jan 15, 2007·Updated Nov 2, 2021

In Brief

A Phase 3 clinical trial evaluating Pyronaridine artesunate and Coartem® (artemether lumefantrine) for Malaria. Completed, enrolled 1,272 participants across 10 sites in 9 countries.

Detailed Summary

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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMalaria
CountriesDemocratic Republic of the Congo, Ghana, Indonesia, Kenya, Mali, Mozambique, Philippines, Senegal, The Gambia
CollaboratorsShin Poong Pharmaceuticals

Timeline

Phase 3CompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJan 15, 2007
Enrollment StartJan 1, 2007
Primary CompletionApr 1, 2008
Study CompletionMay 1, 2008
TodayJul 2, 2026
Enrollment to primary: 1.3 yearsPosted 19.5 years ago

Interventions

Pyronaridine artesunatedrug

Oral PA (180:60mg tablets) once a day plus AL-placebo (twice a day) for 3 consecutive days (Day 0, 1, and 2)

Coartem® (artemether lumefantrine)drug

AL (20:120mg tablets) twice a day plus PA-placebo (once a day) for 3 consecutive days (Day 0, 1, and 2)