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Dexmethylphenidate

Phase 3

ADHD, ADD | Small molecule | Psychiatry |Novartis AG|Last Updated: Dec 21, 2007

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 Enrollment252
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00301236Efficacy, Tolerability and Safety of Dexmethylphenidate HCl Extended-Release Capsules in Children With Attention-Deficit/Hyperactivity DisorderPHASE3 COMPLETED 252 — — Feb 1, 2006Nov 1, 2006Dec 21, 200725 United States
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Study Endpoints
Primary Endpoints
Assessment of the symptoms by the patient's teacher after 5 weeks of treatment.
Secondary Endpoints
Assessment of the symptoms by the patient's parent after five weeks of treatment.
Change in severity of the illness assessed by the physician after 5 weeks of treatment
Improvement of the illness assessed by the physician after 5 weeks of treatment
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Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT
Interventions
NameTypeDescription
Dexmethylphenidate HCl extended-release capsulesDRUG -
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Eligibility Criteria
Age Range6 Years — 12 Years
SexALL
Healthy VolunteersNo
Study Sites25

Inclusion Criteria: * Children 6 - 12 with a diagnosis of ADHD of any type , Same teacher who is willing to complete the assessment during the school term Exclusion Criteria: * Previous cardiac problems of the patient or the parents or current cardiac findings of the patient; Relevant medical con...

Countries:United States
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