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Albendazole and/or Vitamin a

Phase 3

Malnutrition | Small molecule | Other |United Therapeutics Corporation|Last Updated: Nov 7, 2006

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
RandomizedUNCONTROLLED
Total Trials1
Total Enrollment4,000
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00396500Deworming and Vitamin A (DEVTA) Prepilot StudyPHASE3 COMPLETED 4,000Apr 1, 1994Dec 1, 1996Nov 7, 20061 India
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Study Endpoints
Primary Endpoints
Change in weight in 2 years
Secondary Endpoints
Secondary: Weight and Height gain in underweight, stunted and wasted children
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Study Design & Arms
AllocationRANDOMIZED
MaskingNONE
ModelSINGLE_GROUP
PurposeHEALTH_SERVICES_RESEARCH
Interventions
NameTypeDescription
Albendazole (400 mg) and/or Vitamin aDRUG -
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Eligibility Criteria
Age Range1 Year — 5 Years
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: * Local residents * Aged 1-5 years * Informed written parental consent Exclusion Criteria: * Refusal to give consent * prior enrollment in the study

Countries:India
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