drugset / Trial / NCT03497689

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

NCT03497689 ↗

Phase 4 Completed 36 enrolled United Therapeutics
NaSingle-groupOpen-labelTreatment

Summary

This was 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).

Timeline

Start
2019-01-31
Primary completion
2022-05-11
Completion
2022-05-11

Outcome

Met primary endpoint

paper At Week 16, the mean daily oral treprostinil dose was 16.4 mg; 79% of patients met the primary endpoint. PMID 37532157 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject Treprostinil Other / unclassified — Subcutaneous