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bazedoxifene BZA-20

Phase 3

Postmenopause | Small molecule | Endocrine |Pfizer, Inc.|Last Updated: Dec 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
RandomizedDouble-BlindUNCONTROLLEDBiomarker
Total Trials1
Total Enrollment500
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00384072Study Evaluating the Safety and Efficacy of Bazedoxifene in Postmenopausal Asian WomenPHASE3 COMPLETED 500 — — May 1, 2006Sep 1, 2007Dec 28, 200720 China, South Korea +1
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Study Endpoints
Primary Endpoints
The percent change from baseline in lumbar spine bone mineral density (BMD) after 6 months of treatment
Secondary Endpoints
Additional BMD evaluation including total hip, femoral neck and trochanter at 6 months
Serum bone markers at 3 and 6 months
Lipid profile at 3 and 6 months
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Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposePREVENTION
Interventions
NameTypeDescription
bazedoxifene BZA-20DRUG -
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Eligibility Criteria
Age Range45 Years — N/A
SexFEMALE
Healthy VolunteersNo
Study Sites20

Inclusion Criteria: 1. Generally healthy Asian women 45 years of age or older who are at least 1 year postmenopausal 2. Subjects must qualify for one of the following categories (a or b): 1. Greater than 1 year but less than 5 years postmenopausal with at least one of the ospeoporosis risk fact...

Countries:ChinaSouth KoreaTaiwan
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