Malaria

ASAQ

Liberia – Tolerability – ISRCTN40020296 [Completed]
A phase IV randomised study to assess the tolerability of artesunate-amodiaquine (AS-AQ) (Winthrop® fixed dose combination [FDC]) and artemether-lumefantrine for the treatment of uncomplicated falciparum malaria in Liberia.
puce Current Controlled Trials
puce Results in Malaria Journal (2013)

Liberia – Efficacy – ISRCTN51688713 [Completed]
Efficacy of amodiaquine-artesunate and artemether-lumefantrine for the treatment of uncomplicated Plasmodium falciparum malaria in Nimba county, Liberia.
puce Current Controlled Trials
puce Results in Malaria Journal (2013)

India – ISRCTN84408319 [Completed]
Multicentre, open-label randomised clinical trial of efficacy and tolerability of the fixed-dose artesunate/amodiaquine (AS/AQ) combination therapy and amodiaquine (AQ) monotherapy for treatment of uncomplicated falciparum malaria in India.
puce Current Controlled Trials
puce Results in Malaria Journal (2012)

Burkina Faso – ISRCTN07576538 [Completed]
A randomised, controlled, open-label, parallel-group study comparing the efficacy and safety of an oral artesunate-amodiaquine fixed-dose combination therapy over 3 subsequent days to an equivalent dose regimen of the individual drugs for the treatment of children with Plasmodium falciparum.
puce Current Controlled Trials
puce Results in Malaria Journal (2009)
puce Results in Malaria Journal (2009)

Kenya – ISRCTN16409445 [Completed]
Open-label randomised clinical trial of pharmacokinetics, efficacy, and tolerability of the fixed-dose artesunate/amodiaquine combination therapy versus both drugs administered separately for treatment of uncomplicated falciparum malaria in Kenya.
puce Current Controlled Trials
puce Results in Malaria Journal (2014)
puce Results in Antimicrobial Agents and Chemotherapy (2010)

Africa – ATAQ EASY – NCT00316329 [Completed]
To demonstrate the non-inferiority, in terms of clinical and parasitological efficacy on D28 of administration of Coarsucam™ (artesunate+amodiaquine fixed-dose combination), as a single daily dose, in comparison with administration of Coartem® (artemether+lumefantrine).
puce ClinicalTrials.gov
puce Results in Malaria Journal (2009)

ASAQ HNV – ISRCTN70132716 [Completed]
Artesunate and Amodiaquine: tolerability and pharmacokinetic study in healthy normal volunteers of non-fixed and fixed combination in Malaysia.
puce Current Controlled Trials
puce Results in European Journal of Clinical Pharmacology (2009)

 

 

ASMQ

Africa ISRCTN17472707 & PACTR201202000278282 [Completed]
A multicentre, open-label, prospective, randomised, controlled, phase IV study in Africa, assessing efficacy, safety and pharmacokinetics of ASMQ FDC in 940 children with uncomplicated Plasmodium falciparum malaria from Tanzania, Burkina Faso and Kenya versus artemether-lumefantrine.
puce Current Controlled Trials
puce
Pan African Clinical Trials Registry
puce Results in Lancet Infectious Diseases (2016)

India – ISRCTN70618692 [Completed]
Assessment of efficacy, safety and population-pharmacokinetics of the fixed-dose combination of artesunate-mefloquine in the treatment of acute uncomplicated Plasmodium falciparum malaria in India.
puce Current Controlled Trials
puce Results in Malaria Journal (2014)
puce Results in Journal of Vector Borne Diseases (2013)

HNV – ISRCTN22508774 [Completed]
A single dose two-phase crossover study to assess the tolerability and pharmacokinetic parameters of a fixed dose formulation of artesunate-mefloquine and standard dose artesunate and mefloquine as loose tablets in healthy normal volunteers in Thailand.
puce Current Controlled Trials
puce Results in Journal of Bioequivalence & Bioavailability (2010)

Mae Sot – ISRCTN10364429 [Completed]
A randomised, open study to assess the safety and efficacy of a new artesunate-mefloquine coformulation with an equivalent dose regimen of the individual drugs for the treatment of acute uncomplicated falciparum malaria in Thailand.
puce Current Controlled Trials
puce Results in Tropical Medicine & International Health (2006)

 BKK – ISRCTN24192353 [Completed]
A randomised open label trial to assess the efficacy, safety, and pharmacokinetic parameters of a fixed dose formulation of artesunate-mefloquine and standard dose artesunate and mefloquine as loose tablets for treatment of uncomplicated falciparum malaria in Thailand.
puce Current Controlled Trials
puce Results in Antimicrobial Agents and Chemotherapy (2010)