At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 1,271 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, Open-label, Randomised, Multi-centre Study to Assess the Efficacy of Pyronaridine Artesunate (180:60mg) Versus Mefloquine (250mg) Plus Artesunate (100mg) in Children & Adult Patients With Acute Falciparum Malaria
In Brief
A Phase 3 clinical trial evaluating Pyronaridine - artesunate and Mefloquine plus artesunate for Falciparum Malaria. Completed, enrolled 1,271 participants across 9 sites in 7 countries.
Detailed Summary
The primary objective of this phase III clinical study is to compare the efficacy and safety of the fixed combination of pyronaridine artesunate (Pyramax®, PA) with that of the combination of mefloquine plus artesunate (MQ + AS) in children and adults with uncomplicated P falciparum malaria in South East Asia, India and Africa.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsFalciparum Malaria
CountriesBurkina Faso, Cambodia, Côte d’Ivoire, India, Tanzania, Thailand, Vietnam
CollaboratorsShin Poong Pharmaceuticals
Timeline
Phase 3CompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedNov 2006
Enrollment StartJan 2007
Primary CompletionOct 2008
Study CompletionDec 2008
TodayJul 2026
First PostedNov 23, 2006
Enrollment StartJan 1, 2007
Primary CompletionOct 1, 2008
Study CompletionDec 1, 2008
TodayJul 2, 2026
Enrollment to primary: 1.8 yearsPosted 19.6 years ago
Interventions
Pyronaridine - artesunatedrug
once a day for 3 days
Mefloquine plus artesunatedrug
once a day for 3 days