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Ethambutol

Phase 3

Mycobacterium Avium-intracellulare Infection | Small molecule | Infectious Disease |Pfizer, Inc.|Last Updated: Jun 24, 2005

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
Double-BlindUNCONTROLLED
Total Trials1
Total Enrollment -
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00002140A Randomized, Double-Blind, Comparative Study of Azithromycin Versus Clarithromycin in Combination With Ethambutol for the Treatment of Disseminated Mycobacterium Avium Complex (MAC) Infection in AIDs PatientsPHASE3 COMPLETED - - -Jun 24, 200524 United States
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Study Design & Arms
MaskingDOUBLE
PurposeTREATMENT
Interventions
NameTypeDescription
Ethambutol hydrochlorideDRUG -
ClarithromycinDRUG -
AzithromycinDRUG -
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Eligibility Criteria
Age Range13 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites24

Inclusion Criteria Patients must have: * HIV seropositivity. * Disseminated MAC. * No MAC therapy between time of last positive blood culture draw and study entry (single-agent prophylaxis allowed). * Life expectancy of at least 2 months. * Consent of parent or guardian if below legal age of conse...

Countries:United States
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