Welcome to

United Therapeutics Global Medical Affairs

This website is a resource intended for U.S. healthcare professionals only. This site is intended to provide balanced, scientific, and evidence-based answers to unsolicited medical questions. United Therapeutics does not provide medical advice. It is the healthcare professional’s responsibility to use independent clinical judgment when making clinical decisions for individual patients.

This website may include information that has not been approved by the U.S. Food and Drug Administration. For full prescribing information, including indications, contraindications, warnings, precautions, and adverse events, please refer to the approved product labeling.

Are you a U.S. Healthcare professional?

You are now leaving the UnitherMedAffairs.com website.

This link will take you to a site maintained by a third party who is solely responsible for the site’s content. Click CONTINUE to proceed or CLOSE to return to UnitherMedAffairs.com.

CONTINUE

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.

 

For additional information, visit:

ClinicalTrials.gov