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IR quetiapine

Phase 2

Schizophrenia | Small molecule | Psychiatry |AstraZeneca PLC|Last Updated: Jun 11, 2009

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 Enrollment30
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00254787Rapid Dose Escalation of Quetiapine Versus Conventional Escalation in Acute Schizophrenic PatientsPHASE2 COMPLETED 30Jun 1, 2005Jan 1, 2006Jun 11, 20096 Germany
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Study Endpoints
Primary Endpoints
Proportion of patients who discontinue the study treatment due to adverse events (AEs) during the first week (day 1 to day 7) of treatment
Secondary Endpoints
Safety and Tolerability
Number and type of adverse events
Changes in vital signs and weight
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Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT
Interventions
NameTypeDescription
IR (Immediate-Release) quetiapine fumarate (drug)DRUG -
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Eligibility Criteria
Age Range18 Years — 65 Years
SexALL
Healthy VolunteersNo
Study Sites6

Inclusion Criteria: * Men and women age ≥18 to ≤65 years with acute schizophrenia * Provision of written informed consent prior to enrolment Exclusion Criteria: * Meeting the criteria for any other (than schizophrenia) psychotic disorder not in full remission, concomitant organic mental disorder ...

Countries:Germany
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