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Pyronaridine - Artesunate (3:1) Versus Mefloquine Plus Artesunate in Plasmodium Falciparum Malaria Patients

NCT00403260 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 1271

Last updated 2021-11-02

Study results available
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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.

Conditions

  • Falciparum Malaria

Interventions

DRUG

Pyronaridine - artesunate

once a day for 3 days

DRUG

Mefloquine plus artesunate

once a day for 3 days

Sponsors & Collaborators

  • Shin Poong Pharmaceuticals

    collaborator INDUSTRY

  • Medicines for Malaria Venture

    lead OTHER

Principal Investigators

  • Isabelle Borghini-Fuhrer, PhD · Medicines for Malaria Venture

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2007-01-31
Primary Completion
2008-10-31
Completion
2008-12-31

Countries

  • Burkina Faso
  • Cambodia
  • Côte d’Ivoire
  • India
  • Tanzania
  • Thailand
  • Vietnam

Study Locations

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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 NCT00403260 on ClinicalTrials.gov