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Atomoxetine

Phase 2

Attention Deficit Disorder With Hyperactivity | Small molecule | Other |Pfizer, Inc.|Last Updated: Jul 15, 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
RandomizedDouble-BlindUNCONTROLLED
Total Trials1
Total Enrollment241
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00174226Treatment of Adult ADHD With Atomoxetine or Atomoxetine and BusparPHASE2 COMPLETED 241 — — Nov 1, 2004Jan 1, 2006Jul 15, 200811 United States
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Study Endpoints
Primary Endpoints
To assess the efficacy of Atomoxetine-Buspirone (ATX-BSP) vs placebo (PBO) and atomoxetine (ATX) monotherapy in adult patients with ADHD as measured by the mean change across 7 weeks in the Adult ADHD Investigator Symptom Rating Scale (AISRS) total score
Secondary Endpoints
To characterize the safety over 8 weeks of ATX-BSP as compared to PBO and ATX monotherapy. To assess the response rate for the 3 treatment groups based on AISRS and CGI scores.
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Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT
Interventions
NameTypeDescription
AtomoxetineDRUG -
BuspironeDRUG -
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Eligibility Criteria
Age Range18 Years — 55 Years
SexALL
Healthy VolunteersNo
Study Sites11

Inclusion Criteria: * Adults with ADHD Exclusion Criteria: * Other Axis I Psychiatric Disorders

Countries:United States
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