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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: Completed Phase 4 study of Pulmonary Arterial Hypertension, sponsored by United Therapeutics.
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. According to ClinicalTrials.gov, the official US trial registry.
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).
Primary Outcome
The number of subjects that achieved an oral treprostinil dose of ≥4 mg TID (or a total daily dose \[TDD\] of 12 mg) at Week 16 (or a dose of ≥0.057 mg/kg TID \[TDD of 0.171 mg/kg\] for subjects \<70 kg).
Conditions Studied
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
| Field | Value |
|---|---|
| Enrollment Target | 36 participants |
| Start Date | 2019-01-31 |
| Est. Completion | 2022-05-11 |
| Phase | Phase 4 |
What the finished NCT03497689 record still lists
NCT03497689 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 36 participants, a relatively small participant target, below the 462-participant average among 63 other Pulmonary Arterial Hypertension trials with a reported enrollment target (92% lower).
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 lists 11 locations in 9 states (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.
Learn More About Clinical Trials
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Where NCT03497689's enrollment target sits among peer trials
36 36th of 63 higher than 27 of 63 other Pulmonary Arterial Hypertension trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Pulmonary Arterial Hypertension trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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