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Effexor

Phase 3

Depression | Small molecule | Psychiatry |Pfizer, Inc.|Last Updated: May 28, 2007

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
Double-BlindUNCONTROLLED
Total Trials3
Total Enrollment840
FDA Designations
No designations recorded
Clinical Trials (3)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00225524Study Evaluating Long-Term Safety of Effexor XR in Patients With Major Depression.PHASE3 COMPLETED 150 — — Sep 1, 2004 -May 24, 200773 Japan
NCT00225511Study Evaluating Effexor XR for Major Depression.PHASE3 COMPLETED 590 — — Jun 1, 2004 -May 24, 200773 Japan
NCT00225485Study Evaluating Effexor XR in Elderly Patients With Major Depression.PHASE3 COMPLETED 100 — — Dec 1, 2003 -May 28, 200737 Japan
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Study Endpoints
Primary Endpoints
Incidence of adverse events
Response rate of HAM-D17 (Hamilton Rating Scale for Depression) at the final-on-therapy.
Response rate of HAM-D17 (Hamilton Rating Scale for Depression) at the final-on-therapy
Secondary Endpoints
Quantitative data for laboratory data
Difference of total score of HAM-D17 between baseline and final-on-therapy.
Remission rate of HAM-D17 at the final-on-therapy.
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Study Design & Arms
AllocationNON_RANDOMIZED
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Interventions
NameTypeDescription
Effexor XRDRUG -
MilnacipranDRUG -
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Eligibility Criteria
Age Range20 Years — 65 Years
SexALL
Healthy VolunteersNo
Study Sites73

Inclusion Criteria: * Patients who complete the Phase III double-blind study (Protocol Number 0600B1-816) Exclusion Criteria: * Patients with schizophrenia or any other psychotic disorder * Patients with history or presence of bipolar disorder

Countries:Japan
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