drugset / Trial / NCT01588405

Remodulin® to Oral Treprostinil Transition

NCT01588405

Phase 2 Completed 33 enrolled United Therapeutics
NaSingle-groupOpen-labelTreatment

Summary

This multi-center, open-label study will assess the tolerability and safety of transitioning subjects with stable Pulmonary Arterial Hypertension (PAH) from continuous intravenous (IV) or subcutaneous (SC) Remodulin infusion to oral treprostinil (UT-15C sustained release (SR) tablets). This study will consist of an in-hospital transition phase, dose optimization/evaluation phase, and follow up phase.

Timeline

Start
2012-04
Primary completion
2014-07
Completion
2014-12

Drugs

EvaluationDrugModalityDoseRoute
Subject Treprostinil Other / unclassified Oral