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Micronized 17B-estradiol

Phase 2

Atherosclerosis | Small molecule | Cardiovascular |Johnson & Johnson|Last Updated: Dec 11, 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-BlindUNCONTROLLED
Total Trials1
Total Enrollment222
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00115024EPAT: Estrogen in the Prevention of Atherosclerosis TrialPHASE2 COMPLETED 222Apr 1, 1994Nov 1, 1998Dec 11, 20091 United States
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Study Endpoints
Primary Endpoints
rate of change of distal common carotid artery (CCA) far wall intima-media thickness (IMT)
Secondary Endpoints
lipid and non-lipid factors
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Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposePREVENTION
Interventions
NameTypeDescription
Micronized 17B-estradiolDRUG -
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Eligibility Criteria
Age Range46 Years — 80 Years
SexFEMALE
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Postmenopausal female (serum estradiol less than 20 pg/ml) * 46 to 80 years old * Fasting LDL-C levels 130 to 210 mg/dL * Triglyceride levels less than 400 mg/dL * Current non-smoker Exclusion Criteria: * Clinical evidence of cardiovascular disease * HDL-C level less than 30...

Countries:United States
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