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AC2592

Phase 2

Congestive Heart Failure | Small molecule | Cardiovascular |AstraZeneca PLC|Last Updated: Jan 19, 2015

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-BlindPLACEBO_CONTROLLEDBiomarker
Total Trials1
Total Enrollment61
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00099580PROCLAIM: Effect of AC2592 Administered by Continuous Subcutaneous Infusion in Subjects With Advanced Chronic Congestive Heart FailurePHASE2 COMPLETED 61Mar 1, 2005Sep 1, 2006Jan 19, 201529 United States
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Study Endpoints
Primary Endpoints
To examine the safety and tolerability of AC2592 administered by continuous subcutaneous infusion in subjects with chronic congestive heart failure.
6 weeks
To assess the effect of AC2592 administered by continuous subcutaneous infusion on oxygen consumption during maximal tolerated exercise in adult subjects with chronic congestive heart failure.
6 weeks
Secondary Endpoints
To assess the effect of AC2592 administered by continuous subcutaneous infusion on pharmacokinetics, pharmacodynamics, and clinical outcomes in adult subjects with chronic congestive heart failure.
6 weeks
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Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
1EXPERIMENTAL -
2PLACEBO_COMPARATOR -
Interventions
NameTypeDescription
AC2592DRUGcontinuous subcutaneous infusion (via pump), dose based on subject body weight
placeboDRUGcontinuous subcutaneous infusion (via pump), dose based on subject body weight
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites29

Main Inclusion Criteria: * Has heart failure classified as New York Heart Association (NYHA) Class III or Class IV at screening despite treatment with standard therapy. * Is able to perform a treadmill test. * Has an HbA1c of \<= 11%. * Is physically and mentally capable of operating the continuous...

Countries:United States
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