Malaria

ASAQ

Tolerability Phase IV

ISRCTN40020296 |  Liberia  |  Status: Completed

A phase IV randomized 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.

Efficacy

ISRCTN51688713 |  Liberia  |  Status: Completed

Efficacy of amodiaquine-artesunate and artemether-lumefantrine for the treatment of uncomplicated Plasmodium falciparum malaria in Nimba county, Liberia.

Combination & monotherapy

ISRCTN84408319  |  India  |  Status: Completed

Multicentre, open-label randomized 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.

Oral ASAQ

ISRCTN07576538 |  Burkina Faso  |  Status: Completed

A randomized, controlled, open-label, parallel-group study comparing the efficacy and safety of an oral artesunate-amodiaquine fixed-dose combination therapy over three subsequent days to an equivalent dose regimen of the individual drugs for the treatment of children with Plasmodium falciparum.

Pharmokinetics, efficacy, tolerability

ISRCTN16409445 |  Kenya  |  Status: Completed

Open-label randomized 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.

ATAQ EASY  Phase III

NCT00316329 |  Cameroon, Madagascar, Senegal, Mali  |  Status: 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).

ASAQ HNV  

ISRCTN70132716 | Malaysia  |  Status: Completed

Artesunate and Amodiaquine: tolerability and pharmacokinetic study in healthy normal volunteers of non-fixed and fixed combination in Malaysia.

 

 

ASMQ

Pharmacokinetics of ASMQ FDC  Phase IV

ISRCTN17472707 & PACTR201202000278282   |  Tanzania, Burkina Faso, Kenya  |  Status: Completed

A multicentre, open-label, prospective, randomized, 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.

Assessment of efficacy  Phase III

ISRCTN70618692  |  India  |  Status: 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.

HNV

ISRCTN22508774  |  Thailand  |  Status: 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.

Mae Sot  

ISRCTN10364429  |  Thailand  |  Status: Completed

A randomized, 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.

BKK 

ISRCTN24192353   |  Thailand  |  Status: Completed

A randomized 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.