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OROS paliperidone

Phase 3

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 Trials4
Total Enrollment895
FDA Designations
No designations recorded
Clinical Trials (4)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00645307A 52 Week Open Label Extension Trial Following the Recurrence Prevention Study R076477-SCH-301 to Evaluate the Safety and Tolerability of Paliperidone ER in Subjects With Schizophrenia.PHASE3 COMPLETED 235May 1, 2004Aug 1, 2006Jun 8, 2011 -
NCT00650793A 52-week, Open-label Extension Study Following a 6-week, Double-blind, Placebo- and Active- Controlled Study (R076477-SCH-303) to Evaluate the Safety and Tolerability of Paliperidone ER in Subjects With SchizophreniaPHASE3 COMPLETED 473Mar 1, 2004Feb 1, 2006Jun 8, 2011 -
NCT00838669A Study of the Effect of Food and Posture on the Pharmacokinetics of a Single Dose of ER OROS PaliperidonePHASE1 COMPLETED 74Aug 1, 2005Dec 1, 2005May 18, 2011 -
NCT00791232A Study of Extended Release Extended-release (ER) OROS Paliperidone Tolerability, as Compared to Immediate-release (IR)Risperidone, in Patients With SchizophreniaPHASE1 COMPLETED 113Mar 1, 2003Jun 1, 2003Jun 8, 2011 -
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Study Endpoints
Primary Endpoints
Long-term assessment of safety and tolerability of ER OROS paliperidone 3 to 15 mg/day in subjects diagnosed with schizophrenia
Long-term assessment of safety and tolerability of flexibly-dosed ER OROS® paliperidone.
to evaluate the effect of food on the pharmacokinetics of ER OROS paliperidone in ambulant healthy men; to evaluate the effect of posture on the pharmacokinetics of ER OROS paliperidone under fasting conditions
A non-inferiority comparison of the orthostatic tolerability of a higher initial dose of paliperidone OROS with the current recommended initial dose of risperidone in patients with schizophrenia
Secondary Endpoints
Long-term efficacy and effect of ER OROS paliperidone on overall functioning and personal and social functioning, quality of life, health economics, and subjective sleep measures
Assessment of long-term efficacy; Effect on positive and negative symptoms of schizophrenia; Personal and social functioning; Overall functioning; Quality of life parameters
to evaluate the safety and tolerability of the treatments in healthy men
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Study Design & Arms
AllocationNON_RANDOMIZED
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Interventions
NameTypeDescription
Extended Release OROS® PaliperidoneDRUG -
Extended release OROS paliperidoneDRUG -
extended-release (ER) OROS paliperidoneDRUG -
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo

Inclusion Criteria: * Subjects who had experienced a recurrence event during the double blind phase of Study R076477-SCH-301 * Remained recurrence free until the end of the double-blind phase, or were in the run-in or stabilization phases when the study was terminated * Who signed the informed cons...

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