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AZD3480

Phase 2

ADHD | Small molecule | Psychiatry |AstraZeneca PLC|Last Updated: Oct 30, 2009

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-BlindPLACEBO_CONTROLLEDBiomarker
Total Trials1
Total Enrollment24
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00683462An Exploratory Trial of AZD3480 (TC-1734) for the Treatment of Adult Attention-Deficit/Hyperactivity Disorder (ADHD)PHASE2 COMPLETED 24May 1, 2008Jul 1, 2009Oct 30, 20091 United States
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Study Endpoints
Primary Endpoints
The Total Symptoms Scale Score (of ADHD) of the Connors Adult ADHD Rating Scale-Investigator Rating (CAARS-INV).
Visit 1, 2, 3, 4, 5, 8, 9, 10,13, 14 and 15
Secondary Endpoints
Clinical Global Impressions Scales (NIMH 1985)
Visit 1, 2, 3, 4, 5, 8, 9, 10, 13, 14,15
CDR computerized cognitive battery
2, 3, 5, 8, 10, 13, 15
CNRU computerized cognitive battery
2, 3, 5, 8, 10, 13, 15
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Study Design & Arms
AllocationRANDOMIZED
MaskingQUADRUPLE
ModelCROSSOVER
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
1PLACEBO_COMPARATOR -
2EXPERIMENTAL -
3EXPERIMENTAL -
Interventions
NameTypeDescription
PlaceboDRUG -
AZD3480DRUGCapsules 5 mg/day (once a day) for 2 weeks
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Eligibility Criteria
Age Range18 Years — 65 Years
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: * Confirmed diagnosis of DSM-IV ADHD * Score of equal or more than 2 on at least six of nine items in at least one of the subscales of the Connor´s Adult ADHD Rating Scale (CAARS-INV) * Score of equal or more than 4 (at least moderate severity) on the Clinical Global Impressions...

Countries:United States
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Competitive Landscape -ADHD 3 trials
CompanyTickerTrialsLead PhaseDrugs
Supernus Pharmaceuticals, Inc.SUPN1PHASE3SPN-812
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