EXPEDITE: A Study of Remodulin Induction Followed by Orenitram Optimization to Treat Pulmonary Arterial Hypertension

  • STATUS
    Recruiting
  • participants needed
    35
  • sponsor
    United Therapeutics
Updated on 18 January 2022
hypertension
hysterectomy
medical therapy
immunodeficiency
heart disease
connective tissue disease
hypertrophy
treprostinil
remodulin
left ventricular end-diastolic pressure
appetite suppressants

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 subjects with pulmonary arterial hypertension (PAH).

Description

Subjects will be initiated on subcutaneous (SC) or intravenous (IV) treprostinil and titrated to a dose that improves the symptoms of PAH while minimizing excessive pharmacologic effects. After achieving a minimum SC/IV treprostinil dose of 20 ng/kg/min, subjects may begin a transition to oral treprostinil at the Transition Visit, which can occur at the Week 2, 4, or 8 study visit. After the Transition Visit, oral treprostinil titration will continue through Week 16 to reach the maximum tolerated dose.

Details
Condition Pulmonary Arterial Hypertension
Treatment Intravenous/Subcutaneous Treprostinil; Oral Treprostinil
Clinical Study IdentifierNCT03497689
SponsorUnited Therapeutics
Last Modified on18 January 2022

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