CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 36 enrolled
Drug / intervention
Intravenous/Subcutaneous Treprostinil; Oral Treprostinildrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03497689
NCT03497689Phase 4Completed
CompareCT.gov

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

United Therapeutics·interventional·Posted Apr 13, 2018·Updated Aug 7, 2023

In Brief

A Phase 4 clinical trial evaluating Intravenous/Subcutaneous Treprostinil; Oral Treprostinil for Pulmonary Arterial Hypertension. Completed, enrolled 36 participants across 11 sites.

Detailed 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).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPulmonary Arterial Hypertension
CountriesUnited States
Collaborators--

Timeline

Phase 4CompletedFinished
20192020202120222023202420252026
First PostedApr 13, 2018
Enrollment StartJan 31, 2019
Primary CompletionMay 11, 2022
TodayJul 2, 2026
Enrollment to primary: 3.3 yearsPosted 8.2 years ago

Interventions

Intravenous/Subcutaneous Treprostinil; Oral Treprostinildrug

Short-term course of IV or SC treprostinil continuous infusion followed by transition to oral treprostinil extended-release (XR) tablets taken 3 times daily (TID)