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vestipitant/paroxetine

Phase 2

Social Phobia | Small molecule | Other |GSK plc|Last Updated: Sep 15, 2016

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 Enrollment204
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00403962A Combination Therapy In Patients With Social Anxiety DisorderPHASE2 COMPLETED 204 — — Nov 1, 2004Aug 1, 2005Sep 15, 201617 Denmark, Germany +2
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Study Endpoints
Primary Endpoints
Change in score on a Social Anxiety Disorder rating scale following 12 weeks of treatment.
Secondary Endpoints
Change in score on a number of rating scales following 12 weeks of treatment assessing symptomatic, behavioural and functional parameters which together provide a more complete description of the disorder.
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Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT
Interventions
NameTypeDescription
vestipitant/paroxetineDRUG -
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Eligibility Criteria
Age Range18 Years — 64 Years
SexALL
Healthy VolunteersNo
Study Sites17

Inclusion criteria: * Primary diagnosis of Generalised Social Anxiety Disorder as defined in DSM-IV. * Capable of giving informed consent and willing to comply with the study requirements. * Women of childbearing potential must agree to one of a number of defined acceptable methods of birth control...

Countries:DenmarkGermanyNorwaySouth Africa
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