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Treatment with Genotropin in different dosages

Phase 3

Growth Disorder | Small molecule | Other |Pfizer, Inc.|Last Updated: May 3, 2007

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
UNCONTROLLED
Total Trials1
Total Enrollment36
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00174421Treatment Of Short Stature With Genotropin In Children Born Small For Gestational Age Until Final HeightPHASE3 COMPLETED 36Apr 1, 2001Aug 1, 2005May 3, 2007 -
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Study Endpoints
Primary Endpoints
Final height, compared to the expected familial target height
Secondary Endpoints
Body weight, body mass index at final height; adverse events and assessment of hematological and clinical chemistry
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Study Design & Arms
AllocationNON_RANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT
Interventions
NameTypeDescription
Treatment with Genotropin in different dosagesDRUG -
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Eligibility Criteria
SexALL
Healthy VolunteersNo

Inclusion Criteria: * Participation in the 90-080 study Exclusion Criteria: * Any severe, acute or chronic disease * Any other identifiable reason for short stature

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Competitive Landscape -Growth Disorders 4 trials