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Mixed salts of a single-entity amphetamine

Phase 3

Attention Deficit Disorder With Hyperactivity | Small molecule | Other |Takeda Pharmaceutical Company Limited|Last Updated: May 25, 2021

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-BlindUNCONTROLLEDBiomarker
Total Trials1
Total Enrollment36
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00557960ADDERALL XR (Mixed Salts of a Single-entity Amphetamine) and STRATTERA ( Atomoxetine Hydrochloride) Compared to Placebo on Simulated Driving Safety and Performance and Cognitive Functioning in Adults With ADHDPHASE3 COMPLETED 36Feb 25, 2004Oct 25, 2004May 25, 20211 United States
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Study Endpoints
Primary Endpoints
Overall Driving Safety Score derived by the driving simulator
Weeks 3 & 6
Secondary Endpoints
Driving Safety Scores at individual time points
2, 7, and 12 hours post-dose at Weeks 3 & 6
Cog-Screen Aviator Predictor Score, ADHD-RS, CGI, Self-rating of driving simulator performance questionnaire
Weeks 3 & 6
AEs, laboratory screens, PE, vital signs, ECG
6 weeks
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Study Design & Arms
AllocationRANDOMIZED
MaskingQUADRUPLE
ModelCROSSOVER
PurposeTREATMENT
Interventions
NameTypeDescription
Mixed salts of a single-entity amphetamineDRUG -
Atomoxetine hydrochlorideDRUG -
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Eligibility Criteria
Age Range19 Years — 25 Years
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: * primary diagnosis of ADHD * not naive to pharmacologic ADHD treatment * valid driver's license with a minimum of 3 years driving experience Exclusion Criteria: * recent history of drug dependence or substance use disorder * any specific cardiac condition that would, in the o...

Countries:United States
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