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Seroquel Sustained Release

Phase 3

Schizophrenic Disorder | Small molecule | Other |AstraZeneca PLC|Last Updated: Jan 4, 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 Enrollment535
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00206115SR-Registration Study 1, ROW: Efficacy and Safety of Seroquel® in the Treatment of Patients With SchizophreniaPHASE3 COMPLETED 535 — — Nov 1, 2004Dec 1, 2005Jan 4, 201331 Bulgaria, Greece +6
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Study Endpoints
Primary Endpoints
The primary outcome variable will be the change from baseline of the Positive and Negative Syndrome Scale (PANSS) total score at the end of treatment at Day 42.
Secondary Endpoints
Efficacy
To demonstrate a higher PANSS response rate
To demonstrate superior Clinical Global Impressions (CGI) response
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Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT
Interventions
NameTypeDescription
Seroquel Sustained Release (SR)DRUG -
Seroquel Immediate Release (IR)DRUG -
PlaceboDRUG -
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Eligibility Criteria
Age Range18 Years — 65 Years
SexALL
Healthy VolunteersNo
Study Sites31

Inclusion Criteria: * To be considered for this study the patients should be aged between 18 to 65 years, need to suffer from schizophrenia and must be willing to participate. Exclusion Criteria: * Patients that suffer from psychiatric disorders other than schizophrenia including drug abuse and d...

Countries:BulgariaGreeceIndiaIndonesiaPhilippinesRomaniaRussiaSouth Africa
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