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UT-15

Phase 3

Pulmonary Hypertension | Small molecule | Cardiovascular |United Therapeutics Corporation|Last Updated: Mar 25, 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-BlindUNCONTROLLEDBiomarker
Total Trials1
Total Enrollment -
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00004497Phase III Randomized Study of UT-15 in Patients With Primary Pulmonary HypertensionPHASE3 COMPLETED -Oct 1, 1998Sep 1, 2000Mar 25, 20157 United States
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Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
PurposeTREATMENT
Interventions
NameTypeDescription
UT-15DRUG -
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Eligibility Criteria
Age Range8 Years — 75 Years
SexALL
Healthy VolunteersNo
Study Sites7

PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- Diagnosis of moderate to severe precapillary pulmonary hypertension (New York Heart Association class III/IV) unresponsive to attempted use of chronic oral vasodilators for at least 1 month Cardiac catheterization at baseline: Pulmonary artery ...

Countries:United States
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