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AGN 201904

Phase 1

Peptic Ulcer | Small molecule | Other |AbbVie Inc.|Last Updated: Jun 2, 2011

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
RandomizedACTIVE_CONTROLLED
Total Trials1
Total Enrollment150
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00325715AGN 201904 Versus Esomeprazole in the Prevention of Aspirin-induced Stomach or Upper Intestinal Damage in Healthy VolunteersPHASE1 COMPLETED 150Apr 1, 2006Aug 1, 2006Jun 2, 20111 United States
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Study Endpoints
Primary Endpoints
Stomach or upper intestinal erosions
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Study Design & Arms
AllocationRANDOMIZED
MaskingSINGLE
ModelPARALLEL
PurposePREVENTION
Treatment Arms
ArmTypeDescription
1EXPERIMENTAL -
2ACTIVE_COMPARATOR -
Interventions
NameTypeDescription
AGN 201904DRUG -
esomeprazoleDRUG -
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Eligibility Criteria
Age Range18 Years — 65 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Healthy Adult Volunteers who have provided written informed consent Exclusion Criteria: * Volunteers with a history of upper gastrointestinal disease or who have a current diagnosis of upper gastrointestinal disease. * Female volunteers who pregnant, nursing, or planning a p...

Countries:United States
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