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Pyronaridine Artesunate (3:1) Versus Coartem® in P Falciparum Malaria Patients

NCT00422084 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 1272

Last updated 2021-11-02

Study results available
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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.

Conditions

Interventions

DRUG

Pyronaridine artesunate

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

DRUG

Coartem® (artemether lumefantrine)

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

Sponsors & Collaborators

  • Shin Poong Pharmaceuticals

    collaborator INDUSTRY

  • Medicines for Malaria Venture

    lead OTHER

Principal Investigators

  • Claude Oeuvray, PhD · Medicines for Malaria Venture

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
3 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-01-31
Primary Completion
2008-04-30
Completion
2008-05-31

Countries

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

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00422084 on ClinicalTrials.gov