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Milrinone

Phase 2

Valvular Stenosis | Small molecule | Cardiovascular |Stoke Therapeutics, Inc.|Last Updated: Oct 25, 2013

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_CONTROLLED
Total Trials1
Total Enrollment124
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00819377Milrinone Inhaled in Cardiac SurgeryPHASE2 COMPLETED 124 — — Feb 1, 2009Dec 1, 2012Oct 25, 20131 Canada
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Study Endpoints
Primary Endpoints
To demonstrate that inhaled milrinone administered before CPB is superior to placebo in reducing the severity of difficult separation from bypass
End of CPB
Secondary Endpoints
Reduction in morbidity and mortality post-op
At discharge, 3 months, 6 months and 1 year by telephone
Reduction in pulmonary artery pressure
Same day before and after CPB
Right ventricular function measured using transthoracic echocardiography (TTE) and TEE
Same day before and after the CPB
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Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Normal salinePLACEBO_COMPARATORNormal saline by inhalation over 15 min
MilrinoneACTIVE_COMPARATORInhaled milrinone 5 mg(as for the injectable solution)
Interventions
NameTypeDescription
MilrinoneDRUGinhaled milrinone 5 mg (as for the injectable solution)
Normal salineDRUG5 ml normal saline by inhalation over 15 min
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Eligibility Criteria
Age Range18 Years — 90 Years
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: * Adult patients scheduled for elective valvular or complex (2 or more valves or * valve and revascularization) cardiac surgery under CPB with preoperative PHT defined as mean pulmonary artery pressure (MPAP) over 30 mmHg or * systolic pulmonary artery pressure (SPAP) over 40 mm...

Countries:Canada
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