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bupropion

Phase 3

Attention Deficit Disorder | Small molecule | Other |GSK plc|Last Updated: Feb 12, 2013

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 Enrollment162
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00048360Attention-Deficit Hyperactivity Disorder (ADHD) Study With AdultsPHASE3 COMPLETED 162Oct 1, 2002Jun 1, 2003Feb 12, 201321 United States
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Study Endpoints
Primary Endpoints
ADHD Rating Scale
Secondary Endpoints
Clinical Global Impressions -Severity and Improvement.
Quality of Life Enjoyment and Satisfaction Questionnaire.
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Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT
Interventions
NameTypeDescription
Extended-release bupropion hydrochlorideDRUG -
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Eligibility Criteria
Age Range18 Years — 60 Years
SexALL
Healthy VolunteersNo
Study Sites21

Inclusion criteria: * Patient must be diagnosed with ADHD. Exclusion Criteria: * Patient has a current or past history of seizure disorder, brain injury, anorexia nervosa or bulimia. * Patient has a current diagnosis of Major Depressive Disorder (MDD). * Patient has a current primary diagnosis of...

Countries:United States
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