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AZD8529

Phase 2

Schizophrenia | Small molecule | Psychiatry |AstraZeneca PLC|Last Updated: Nov 1, 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-BlindPLACEBO_CONTROLLEDBiomarker
Total Trials2
Total Enrollment355
FDA Designations
No designations recorded
Clinical Trials (2)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00921804Study to Assess the Efficacy, Safety, and Tolerability of AZD8529 in Adult Schizophrenia PatientsPHASE2 COMPLETED 296Jun 1, 2009May 1, 2010Jun 30, 20103 United States
NCT00986531The Effects AZD8529 on Cognition and Negative Symptoms in SchizophrenicsPHASE1 COMPLETED 59Nov 1, 2009Oct 1, 2011Nov 1, 20111 United States
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Study Endpoints
Primary Endpoints
PANSS Total Score
Prior to randomization (screening, admission to washout/run in, baseline) and Days 8, 15, 22, and 28
Functional magnetic resonance imaging (fMRI)
1 fMRI on Day 4; 1 fMRI on Day 21
Computerized neurocognitive tests
1 on Day -1; 1 on Day 1 and on Day 21
Secondary Endpoints
PANSS Positive, Negative, and General Psychopathology Subscale Scores
Prior to randomization (screening, admission to washout/run in, baseline) and Days 8, 15, 22, and 28
CGI-S
Prior to randomization (screening, admission to washout/run in, baseline) and Days 8, 15, 22, and 28
Vital signs measurements, body weight, physical exam, clinical laboratory evaluations, ECGs, Extrapyramidal Symptoms, suicidal symptoms, cognition and incidence of adverse events
Prior to randomization (screening, admission to washout/run in, baseline) and Days 1, 8, 15, 22, and 28
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Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
1EXPERIMENTALAZD8529 40 mg
2PLACEBO_COMPARATORPlacebo
3OTHERRisperidone 4 mg (2mg on Day 1)
Interventions
NameTypeDescription
AZD 8529DRUG40mg oral daily capsule administered as a single dose in the morning for 28 days
RisperidoneDRUG4mg (2mg on Day 1) oral daily capsule administered as a single dose in the evening for 28 days
Placebo to match AZD8529DRUGPlacebo to match AZD8529 administered as a daily capsule in the morning for 28 days during the treatment period and also during the 3-7 day washout or run-in period
Placebo to match risperidoneDRUGPlacebo to match risperidone administered as a daily capsule in the evening for 28 days during the treatment period and also during the 3-7 day washout or run-in period
AZD8529DRUG2 capsules by mouth for 3 days
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Eligibility Criteria
Age Range18 Years — 65 Years
SexALL
Healthy VolunteersNo
Study Sites3

Inclusion Criteria: * Patient will need to read, understand and sign an informed consent prior to any study specific procedures * Patient will have certain schizophrenia symptoms deemed by the investigator as appropriate for the study entry Exclusion Criteria: * Patients will be excluded based on...

Countries:United States
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