At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 456 enrolled
Drug / intervention
Pyronaridine artesunate +1 moredrug
Likely dose
Not stated in 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.
A Phase III Comparative (Double-blind, Double-dummy) Randomised Multicentre Study to Assess the Safety & Efficacy of Oral Pyronaridine Artesunate (180:60 mg) Versus Chloroquine (155 mg) in Children & Adult Patients With Acute Vivax Malaria
In Brief
A Phase 3 clinical trial evaluating Pyronaridine artesunate and Chloroquine for Malaria. Completed, enrolled 456 participants across 5 sites in 4 countries.
Detailed Summary
The purpose of this study is to compare the efficacy and safety of the fixed combination of pyronaridine artesunate (Pyramax®, PA) (180:60 mg) with that of standard chloroquine therapy in children and adults with acute, uncomplicated Plasmodium vivax malaria.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMalaria
CountriesCambodia, India, Indonesia, Thailand
CollaboratorsShin Poong Pharmaceuticals
Timeline
Phase 3CompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedFeb 2007
Enrollment StartMar 2007
Primary CompletionApr 2008
Study CompletionSep 2008
TodayJul 2026
First PostedFeb 27, 2007
Enrollment StartMar 1, 2007
Primary CompletionApr 1, 2008
Study CompletionSep 1, 2008
TodayJul 2, 2026
Enrollment to primary: 1.1 yearsPosted 19.3 years ago
Interventions
Pyronaridine artesunatedrug
Chloroquinedrug