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Seloken ZOK/Toprol-XL

Phase 3

Heart Failure, Congestive | Small molecule | Cardiovascular |AstraZeneca PLC|Last Updated: Nov 19, 2010

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 Enrollment300
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00038077Reversal of Ventricular Remodeling With Toprol-XLPHASE3 COMPLETED 300Aug 1, 2001Sep 1, 2003Nov 19, 201044 United States
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Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
PurposeTREATMENT
Interventions
NameTypeDescription
Seloken ZOK/Toprol-XLDRUG50 mg
PlaceboDRUG -
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites44

Inclusion Criteria: * Diagnosis of stable asymptomatic heart failure. * Documented ejection fraction less than 0.40. * Must be able to comply with all study procedures. Exclusion Criteria: * Taken B-blocker therapy for longer than 1 week within 6 months prior to randomization. * Have heart proble...

Countries:United States
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