Atovaquone_proguanil has been approved in the United States and in the European Union and in the Other Countries

Studies listed may include approved and non-approved uses, formulations or treatment regimens. Before prescribing any product mentioned in this Register, healthcare Professionals should consult prescribing information approved in their country (view UK and US information for Healthcare Professionals).

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atovaquone_proguanil studies

Select the study ID number to view the trial summary

Study IDPhaseTitle
EPI40105 IV A post-marketing surveillance study of subject-reported adverse events rates for Malarone (atovaquone and proguanil), mefloquine and chloroquine/proguanil, when used for prophylaxis for travel up to 28 days maximum
MAL30015 IV A Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study to Evaluate the Safety and Efficacy of MALARONE (Atovaquone and Proguanil Hydrochloride) for the Prevention of Plasmodium falciparum Malaria in Gabonese Children, and the Effect on Antibody Response to Typhoid and Cholera Vaccines, Using MALARONE Pediatric Tablets Manufactured in Canada
MAL40009 IV An Open-Label, Uncontrolled Study to Evaluate the Safety and Efficacy of MALARONE (Atovaquone and Proguanil Hydrochloride) for Treatment of Acute Plasmodium falciparum Malaria in Thailand Using Tablets Manufactured in Canada
MAL40010 IV A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of Malarone (atovaquone and proguanil hydrochloride) for Malaria Prophylaxis in Non-Immune Colombian Soldiers.
115-003 III A Multicentre Pilot Study in the United Kingdom to Determine Whether 566C80 Exhibits Antimalarial Activity in Patients with P. Falciparum Malaria. Extensive searching has revealed that no clinical study report is available for this study. The clinical trial results were reported via publication; see citation below.
115-120 III A Comparative Trial of a Combination of Atovaquone and Proguanil versus Chloroquine or Fansidar in the Treatment of Acute P. falciparum Malaria in Adults in Zambia
115-122 III Comparative Clinical Trial of a Combination of Atovaquone and Proguanil with Mefloquine in the Treatment of Acute P. falciparum Malaria in Adults in Thailand
115-123 III Uncontrolled Clinical Trial of a Combination of Atovaquone and Proguanil in the Treatment of Acute P. falciparum Malaria in Children in Thailand
115-127 III Comparative Clinical Trial of a Combination of Atovaquone and Proguanil Versus a Combination of Quinine and Tetracycline in the Treatment of Acute P. falciparum Malaria in Adults in Brazil
115-130 III Comparative clinical trial of a combination of atovaquone and proguanil versus halofantrine in the treatment of acute P. falciparum malaria in non-immune adults in Europe
115-131 III Comparative clinical trial of a combination of atovaquone and proguanil versus halofantrine in the treatment of acute P. falciparum malaria in children in Kenya
115-134 III Comparative clinical trial of a combination of atovaquone and proguanil versus amodiaquine in the treatment of acute P. falciparum malaria in adults in Gabon
115-135 III Final Study Report for Protocol 115-135: Comparative Clinical Trial of a Combination of Atovaquone and Proguanil versus Chloroquine in the Treatment of Acute P. falciparum Malaria in Adults and Children in the Philippines
115-136 III Comparative Clinical Trial of a Fixed Formulation of Atovaquone and Proguanil tablets (MALARONE) Versus Chloroquine in the Treatment of Acute P. falciparum Malaria in Adults or Children in Peru
MAL30010 III An International, Randomized, Double-Blind Study to Compare the Safety and Efficacy of MALARONE (Atovaquone and Proguanil Hydrochloride) Versus Mefloquine for Chemoprophylaxis Against Malaria in Non-Immune Travelers
MAL30011 III An International, Randomized, Double-Blind Study to Compare the Safety and Efficacy of MALARONE (Atovaquone and Proguanil Hydrochloride) Versus Chloroquine and Proguanil Hydrochloride for Chemoprophylaxis Against Malaria in Non-Immune Travelers
MAL30012 III An International, Randomized, Open-Label Study to Compare the Safety and Efficacy of MALARONE (Atovaquone and Proguanil Hydrochloride) Versus Chloroquine and Proguanil Hydrochloride for Chemoprophylaxis Against Malaria in Non-Immune Pediatric Travelers
MAL30013 III An Open-Label Comparative Study to Determine the Safety and Efficacy of MALARONE (Atovaquone and Proguanil Hydrochloride) Versus Amodiaquine in the Treatment of Acute Plasmodium falciparum Malaria in Children Weighing ³5 and <11kg in Gabon
MAL30014 III A Randomized, Double-Blind, Placebo-Controlled Study of MALARONE (Atovaquone and Proguanil Hydrochloride) as a Causal Prophylactic Agent Against Mosquito-Transmitted P. falciparum Malaria in Healthy Non-Immune Volunteers
MALA4001 III An Open Label Study to Determine the Safety and Efficacy of a Sequential Treatment Regimen of MALARONE (atovaquone/proguanil) Followed by Primaquine in the Treatment of Acute Plasmodium vivax Malaria in Adults
MALA4002 III An Open-Label Study to Determine the Efficacy and Safety of a Sequential Treatment Regimen of MALARONE (Atovaquone and Proguanil Hydrochloride) Followed by Primaquine for the Treatment of Acute Plasmodium Vivax Malaria in Thailand.
MALB3001 III A Randomised, Double–Blind, Placebo–Controlled, Parallel Group Study to Evaluate the Suppressive Prophylactic Activity of MALARONE (atovaquone/proguanil) in Volunteers at Risk of Developing P. falciparum Malaria in Zambia
MALB3002 III An Open-Label Study to Evaluate the Safety and Efficacy of MALARONE (atovaquone/proguanil) as a Suppressive Prophylactic Agent Against Plasmodium falciparum Malaria in South Africa
MALB3003 III A Randomised, Double–Blind, Placebo–Controlled, Parallel Group Study to Evaluate the Suppressive Prophylactic Activity of MALARONE (atovaquone/proguanil) in Children at Risk of Developing Plasmodium falciparum Infection
MALB3005 III A Randomized, Double-Blind, Placebo-Controlled Trial of Malarone (Atovaquone 250mg and Proguanil Hydrochloride 100mg) Daily for Prophylaxis Against Plasmodium vivax and Plasmodium falciparum Infection in Javanese Transmigrants to Irian Jaya, Indonesia
MALB3006 III An Open-Label Comparative Study to Determine the Safety and Efficacy of MALARONE (Atovaquone and Proguanil Hydrochloride) Versus Chloroquine in the Treatment of Acute Plasmodium falciparum Malaria in Children ³5 and <11 kg in Weight in Nigeria
115-005 II An Open Study to Determine Whether 566C80 (Atovaquone) Exhibits Antimalarial Activity in Thai Patients with P. falciparum Malaria
115-012 II An open study to determine whether 566C80 (atovaquone) exhibits antimalarial activity in Zambian patients with P. falciparum malaria
MALB2001 II A Randomised, Double-Blind, Placebo-Controlled, Parallel Group Study to Determine the Chemosuppressive Activity of a Fixed Dose Combination of Atovaquone/Proguanil (MALARONE) in Volunteers at Risk of Developing P. falciparum Malaria in Kenya
MALB2002 II Prophylactic Antimalarial Activity of Atovaquone in Volunteers Challenged with Plasmodium falciparum
115-132-V I A Study to Compare the Bioavailability of Atovaquone and Proguanil from Combination Tablets and from Atovaquone Tablets and Proguanil Tablets given Concomitantly
115-133 I Report of a Randomised Study to Evaluate a Potential Pharmacokinetic Interaction between Proguanil and Atovaquone in Healthy Adult Volunteers
MAL10907 I An open label, parallel group, single oral dose study to investigate the pharmacokinetics of MALARONE in healthy elderly subjects compared to healthy young subjects
MAL10908 I An open label, parallel group, single oral dose study to investigate the pharmacokinetics of MALARONE in subjects with severe renal impairment compared to healthy subjects.
MAL10909 I An Open Label, Parallel Group, Single Oral Dose Study to Investigate the Pharmacokinetics of MALARONE in Subjects with Mild to Moderate Hepatic Impairment Compared to Healthy Subjects