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ABT-894

Phase 2

Attention-Deficit/Hyperactivity Disorder | Small molecule | Psychiatry |Abbott Laboratories|Last Updated: Nov 2, 2010

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 Enrollment243
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00429091A Dose-Ranging Study of the Efficacy of ABT-894 in Adults With Attention-Deficit/Hyperactivity Disorder (ADHD)PHASE2 COMPLETED 243Jan 1, 2007 -Nov 2, 201022 United States
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Study Endpoints
Primary Endpoints
CAARS:Inv Total Score (Sum of Inattentive and Hyperactive/Impulsive Sub-scales)
Final Evaluation of each 4-week Treatment Period
Secondary Endpoints
CAARS Inattentive and Hyperactive/Impulsive Sub-scales Scores
Final Evaluation of each 4-week Treatment Period
CAARS ADHD Index
Final Evaluation of each 4-week Treatment Period
CGI-ADHD-S
Final Evaluation of each 4-week Treatment Period
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Study Design & Arms
AllocationRANDOMIZED
MaskingQUADRUPLE
ModelCROSSOVER
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
1PLACEBO_COMPARATOR -
2EXPERIMENTAL -
3ACTIVE_COMPARATOR -
Interventions
NameTypeDescription
ABT-894DRUGSubjects will take 1 mg QD, 2 mg QD, 4 mg QD, 4 mg BID for up to four weeks.
atomoxetineDRUGSubjects will take 40 mg BID or placebo for up to four weeks.
placeboDRUGSubjects will take BID for up to four weeks
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Eligibility Criteria
Age Range18 Years — 60 Years
SexALL
Healthy VolunteersNo
Study Sites22

Inclusion Criteria: * Meet criteria for attention-deficit/hyperactivity disorder * Have voluntarily signed an informed form * Are between 18 and 60 years of age * Will use contraceptive methods during the study * Women must not be pregnant or breast-feeding * Must be in generally good health * Are ...

Countries:United States
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