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NCT03497689 · ClinicalTrials.gov registry record · Phase 4

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

A Phase 4 study of Pulmonary Arterial Hypertension, sponsored by United Therapeutics.

Completed
Registry status
Phase 4
Development phase
36
Enrollment target
11
Study locations

NCT03497689 is a Phase 4 study of Pulmonary Arterial Hypertension that has completed, run by United Therapeutics. The registered enrollment target is 36 participants, below the 462-participant average among 63 other Pulmonary Arterial Hypertension trials with a reported enrollment target (92% lower). The trial reports 11 study locations across 9 states.

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The verdict

NCT03497689, a Phase 4 study of Pulmonary Arterial Hypertension, has completed, sponsored by United Therapeutics.

COMPLETED
Registry status
Phase 4
Development phase
36 participants
Enrollment target
11
Study locations

Study 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).

Conditions Studied

Pulmonary Arterial Hypertension

Interventions

  • DRUG Intravenous/Subcutaneous Treprostinil; Oral Treprostinil

Study Locations (11)

California

  • University of California San Francisco - Fresno - Fresno
  • Harbor-UCLA Medical Center - Torrance

Ohio

  • University of Cincinnati Health - Cincinnati
  • The Ohio State University Wexner Medical Center - Columbus

Florida

  • Florida Hospital - Orlando

Georgia

  • Piedmont Healthcare Pulmonary and Critical Care Research - Austell

Indiana

  • St. Vincent Medical Group - Indianapolis

Nebraska

  • University of Nebraska Medical Center - Omaha

New Mexico

  • University of New Mexico Health Sciences Center - Albuquerque

Oklahoma

  • Integris Baptist Medical Center - Oklahoma City

Trial Details

FieldValue
Enrollment Target 36 participants
Start Date 2019-01-31
Est. Completion 2022-05-11
Phase Phase 4

Sponsor

United Therapeutics

63 total trials

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What the Registry Record Tells You About NCT03497689

The ClinicalTrials.gov registry entry for NCT03497689 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 36 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 462-participant average among 63 other Pulmonary Arterial Hypertension trials with a reported enrollment target (92% lower). The listed sponsor is United Therapeutics, which has 63 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Pulmonary Arterial Hypertension appearing as the primary indexed condition, and to 1 intervention - of which Intravenous/Subcutaneous Treprostinil; Oral Treprostinil is the first listed.

NCT03497689 reports 11 study locations spanning 9 distinct geographic areas - top geographies include California, Ohio, Florida.

Frequently Asked Questions

What is clinical trial NCT03497689 about?

NCT03497689 is a clinical study titled "EXPEDITE: A Study of Remodulin Induction Followed by Orenitram Optimization to Treat Pulmonary Arterial Hypertension". 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).

What is the current status of trial NCT03497689?

This trial is currently completed. It is a Phase 4 study. The enrollment target is 36 participants. The study started on 2019-01-31. Estimated completion is 2022-05-11.

What conditions does trial NCT03497689 study?

This clinical trial studies the following conditions: Pulmonary Arterial Hypertension.

What interventions are being tested in trial NCT03497689?

The interventions under investigation include: Intravenous/Subcutaneous Treprostinil; Oral Treprostinil (DRUG).

Who is sponsoring clinical trial NCT03497689?

This trial is sponsored by United Therapeutics, which has 63 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT03497689 being conducted?

This trial has 11 study locations across California, Florida, Georgia, Indiana, Nebraska. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.