A 16-Week, Multicenter, Open-label Study of Remodulin Induction Followed by Orenitram Optimization in Subjects with Pulmonary Arterial Hypertension

This is a prospective, multicenter, open-label study to evaluate whether a short-term course of Remodulin (treprostinil for injection) can assist patients to quickly achieve an optimal dose of Orenitram (oral treprostinil) for the treatment of pulmonary arterial hypertension (PAH). Patients will be evaluated for 16 weeks to observe:

  • Oral treprostinil dosing
  • Prostacyclin-related adverse events
  • Exercise capacity
  • Health-related quality of life

Key inclusion criteria:

  • Patient is new to prostanoid therapy
  • On oral background therapy consisting of one or two FDA approved therapies
  • Diagnosed with WHO Group 1 pulmonary hypertension (PAH)
  • WHO FC III symptoms

Key exclusion criteria:

  • Patient is a pregnant female
  • Severe liver or kidney disease
  • Participating in another clinical study

Clinic responsibilites:

  • Enrollment of patients
  • Initiate treatment using Remodulin
  • Transition patients to Orenitram
  • Routine follow-up with patients via phone and/or email
  • Perform study-specific visits, interventional procedures, and laboratory tests

Patient responsibilites:

  • Record Remodulin and Orenitram usage and tolerability using a diary
  • Quality-of-life surveys and treatment satisfaction questionnaires
  • Attend up to 8 study visits for routine monitoring

Target enrollment is 30 patients.

For questions, email EXPEDITE@unither.com.