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treprostinil dienthanolmine sustained release

Phase 2

Critical Limb Ischemia | Small molecule | Other |United Therapeutics Corporation|Last Updated: Apr 24, 2023

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 Enrollment7
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00651885Safety Study of UT-15C SR (Oral Treprostinil) in Patients Undergoing a Lower Limb Endovascular ProcedurePHASE2 COMPLETED 7 — — Mar 1, 2008Dec 1, 2010Apr 24, 20231 United States
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Study Endpoints
Primary Endpoints
To assess the tolerability and safety of UT-15C SR as compared to placebo tablets in subjects with critical limb ischemia (CLI) undergoing an infra-popliteal endovascular intervention procedure.
12 weeks
Secondary Endpoints
To assess the efficacy of UT-15C SR as compared to placebo tablets on measures of clinical outcomes in subjects with critical limb ischemia (CLI) undergoing an infra-popliteal endovascular intervention procedure.
12-52 weeks
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Study Design & Arms
AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
2 armPLACEBO_COMPARATOR -
1 armEXPERIMENTALtreprostinil dienthalomine
Interventions
NameTypeDescription
treprostinil dienthanolmine sustained releaseDRUGUT-15C SR 1mg tablet
PlaceboDRUGPlacebo
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: 1. Be 18 or older. 2. Have an anticipated infra-popliteal endovascular intervention. 3. Have a diagnosis of stage IIb- IVa (Fontaine) or stage 3- 5 (Rutherford scale) CLI due to documented peripheral arterial disease (Appendix E) 4. If female, be physiologically incapable of chi...

Countries:United States
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