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AZD2624

Phase 2

Schizophrenia | Small molecule | Psychiatry |AstraZeneca PLC|Last Updated: Mar 29, 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-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment106
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00686998Phase IIA Study in Patients With SchizophreniaPHASE2 COMPLETED 106May 1, 2008Mar 1, 2009Mar 29, 20131 United States
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Study Endpoints
Primary Endpoints
Positive and Negative Syndrome Scale (PANSS) Total Score Change From Baseline
Baseline, Day 28

PANSS total score, sum of 30 item scores (each on a 0 to 7 scale), assesses positive and negative symptoms of psychopathology on a continuous scale from 0 (the best) to 210 (the worst). Day 28 value was calculated using last observation carried forward (LOCF). Change from baseline was calculated as Day 28 value minus baseline value.

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Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
AZD2624EXPERIMENTALAZD2624 40 mg
OlanzapineOTHEROlanzapine 15 mg
PlaceboPLACEBO_COMPARATORMatching Placebo
Interventions
NameTypeDescription
AZD2624DRUGOral Suspension
OlanzapineDRUGPO BID
PlaceboDRUG -
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Eligibility Criteria
Age Range18 Years — 65 Years
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: * Females of non-childbearing potential * Diagnosis of Schizophrenia Exclusion Criteria: * Clinically relevant disease and /or abnormalities. * Alcohol or substance abuse not in remission * Enrollment in another investigational study within 30 days

Countries:United States
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