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Immediate release Paliperidone

Phase 1

Schizophrenia | Small molecule | Psychiatry |Johnson & Johnson|Last Updated: Jun 8, 2011

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 Enrollment141
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00791349A Study of QT and QTc Intervals in Patients Administered Immediate Release PaliperidonePHASE1 COMPLETED 141Feb 1, 2005May 1, 2005Jun 8, 2011 -
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Study Endpoints
Primary Endpoints
To assess the cardiovascular safety of paliperidone in schizophrenic or schizoaffective patients, with particular attention to the length of the QT/QTc interval. Other ECG parameters, such as QRS and PR intervals, will also be carefully measured
Secondary Endpoints
To explore the relationship between the pharmacokinetics of paliperidone and ECG parameters of interest, and to explore the safety and tolerability of paliperidone
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Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT
Interventions
NameTypeDescription
Immediate release (IR) PaliperidoneDRUG -
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Eligibility Criteria
Age Range18 Years — 50 Years
SexALL
Healthy VolunteersNo

Inclusion Criteria: * Patients must have a diagnosis of schizophrenia or schizoaffective disorder as defined by DSM-IV criteria, with no exacerbation of psychosis for at least 3 months prior to screening * Patients must have a normal 12-lead ECG at screening and on Day -1, including: Normal sinus r...

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