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Mefloquine

Phase 3

Malaria | Small molecule | Infectious Disease |Pfizer, Inc.|Last Updated: Sep 16, 2008

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
RandomizedCONTROLLED
Total Trials1
Total Enrollment397
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00367653Azithromycin Plus Chloroquine Versus Mefloquine In the Treatment of Uncomplicated P. Falciparum Malaria.PHASE3 COMPLETED 397 — — Nov 1, 2006Sep 1, 2007Sep 16, 20088 Burkina Faso, Ghana +4
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Study Endpoints
Primary Endpoints
The primary objective is to confirm the hypothesis that azithromycin plus chloroquine is noninferior to mefloquine for the treatment of symptomatic, uncomplicated malaria due to P. falciparum in Africa.
duration of trial
The primary endpoint of the study will be the asexual P. falciparum Parasite Clearance Rates (adjusted for molecular testing determining recrudescence, true failures, from reinfection, true cures) at Day 28 in the Parasitologic Per Protocol population.
duration of trial
Secondary Endpoints
A secondary objective is to assess the efficacy of azithromycin plus chloroquine.
duration of trial
Additional secondary objectives include an assessment of the safety and tolerability of all treatment regimens.
duration of trial
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Study Design & Arms
AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
1EXPERIMENTAL -
2EXPERIMENTAL -
Interventions
NameTypeDescription
Azithromycin plus ChloroquineDRUGAzithromycin 1000 mg by mouth (PO) (two 500 mg tablets) once daily (QD) for 3 days(Days 0, 1, 2) plus chloroquine 600 mg base PO once daily for 3 days (Days 0, 1, 2)
MefloquineDRUGMefloquine 1250 mg PO given as a split dose (750 mg \[three 250 mg capsules\]) initial dose followed by 500 mg PO (two 250 mg capsules) given 6 to 10 hours later on Day 0
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites8

Inclusion Criteria: * Females and males 18 years of age and older with uncomplicated, symptomatic malaria as as indicated by the presence of both of the following: * Blood smears positive for Plasmodium falciparum asexual parasitemia between 1000 -100,000 parasites * Documented fever (38.5 C/101.3 ...

Countries:Burkina FasoGhanaKenyaMaliSenegalZambia
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Competitive Landscape -Malaria 8 trials
CompanyTickerTrialsLead PhaseDrugs
GSK plc Sponsored ADRGSK4PHASE3Tafenoquine, Primaquine, Chloroquine, GSK3772701, RTS,S/AS01E vaccine
Novartis AG Sponsored ADRNVS1PHASE2INE963, KAE609, KLU156
60 Degrees Pharmaceuticals, Inc.SXTP1PHASE2Tafenoquine
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