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Clinical Trial Summary

This is a multicenter, open-label study to evaluate the dose of Orenitram® (treprostinil) Extended Release Tablets achieved at 16 weeks after a short-term course of Remodulin® (treprostinil) Injection in prostanoid-naive subjects with pulmonary arterial hypertension (PAH).


Clinical Trial Description

Subjects will be initiated on subcutaneous (SC) or intravenous (IV) treprostinil and titrated to a target dose of 20 to 30 ng/kg/min. After achieving the target SC/IV treprostinil dose, subjects may begin a transition to oral treprostinil at the Transition Visit which can occur at Week 2, 4, or 8. After the Transition Visit, oral treprostinil titration will continue through Week 16 to reach the maximum tolerated dose. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT03497689
Study type Interventional
Source United Therapeutics
Contact Bucky Turpin
Phone (919) 425-5492
Email bturpin@unither.com
Status Not yet recruiting
Phase Phase 4
Start date June 2018
Completion date October 2019

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