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amibegron

Phase 3

Major Depressive Disorder | Small molecule | Psychiatry |Sanofi|Last Updated: Mar 25, 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 Enrollment680
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00385307Efficacy and Safety of SR58611A in Patients With Major Depressive Disorder (SIRIUS)PHASE3 COMPLETED 680Sep 1, 2006Nov 1, 2007Mar 25, 20091 United States
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Study Endpoints
Primary Endpoints
Change from baseline in total score of a depression rating scale at 8 weeks
Secondary Endpoints
Safety assessments
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Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT
Interventions
NameTypeDescription
amibegron (SR58611A)DRUG -
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Eligibility Criteria
Age Range18 Years — 65 Years
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: * Patient with Major Depressive Disorder diagnosed according to Diagnostic and Statistical Manual of Mental Disorders DSM-IV-TR * Patient meets criteria for a recurrent Major Depressive Episode (MDE) * Patient meets severity assessments of depression specified by the study Excl...

Countries:United States
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