12 and older, any sex, with Pulmonary Arterial Hypertension. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Change in Exercise Capacity at Month 12Primary· From First Visit (Visit 1) to Month 12
Assess the effect of continued therapy with oral treprostinil on exercise capacity as assessed by the change from Baseline in 6-Minute Walk Test (6MWT) after 1 year of treatment. The 6MWT is the clinical standard for assessing subject functional status in the treatment of PAH and has been considered an objective measure of subject functional status by the American Thoracic Society. The distance a subject can walk in 6 minutes is recorded in meters.
Group
Value
95% CI
Oral Treprostinil
22.0
-345.0 – 282.0
Adverse events — posted to ClinicalTrials.gov
Time frame: From the time of subject enrollment until exit from the study (up to 13 years)..
Reporting threshold: 5%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
This study provided/continued to provide oral treprostinil (UT-15C SR; treprostinil diethanolamine) to eligible subjects who participated in Studies TDE-PH-202, TDE-PH-203, TDE-PH-205, TDE-PH-301, TDE-PH-302, and TDE-PH-308. The study assessed the long term safety of oral treprostinil and the effect of continued treatment with oral treprostinil on exercise capacity after 1 year of treatment.
Publications & conference data
3 peer-reviewed publications reference this trial (live from Europe PMC):
NCT05203510 — A Study of a Mean Pulmonary Artery Pressure-Targeted Approach With Early and Rapid Treprostinil Therapy to Reverse Right
· Phase 4
· active not recruiting
Other recruiting trials for Pulmonary Arterial Hypertension
Currently open trials in the same condition.
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· active not recruiting
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· recruiting
NCT07217522 — Rutgers University Study of the Genetics of Pulmonary Hypertension
· recruiting
NCT07013149 — The Impact of ERA Switching on Risk Stratification in Pulmonary Arterial Hypertension
· recruiting
NCT06658522 — Right Ventricular Compensation With Sotatercept: A Prospective Single Arm Open Label Phase 4 Study to Evaluate the Effec
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· recruiting
Other United Therapeutics trials
Trials by the same sponsor.
NCT06388421 — DeciPHer-ILD: A Real-world Patient Registry in Group 3 Pulmonary Hypertension Associated With Interstitial Lung Disease
· recruiting
NCT05060315 — Evaluate Real-World Use of Next Generation Infusion Pumps to Administer Remodulin
· terminated
NCT05203510 — A Study of a Mean Pulmonary Artery Pressure-Targeted Approach With Early and Rapid Treprostinil Therapy to Reverse Right
· Phase 4
· active not recruiting
NCT05255991 — Multinational Study of Efficacy and Safety of Inhaled Treprostinil in Subjects With Idiopathic Pulmonary Fibrosis
· Phase 3
· completed
NCT04708782 — Study of Efficacy and Safety of Inhaled Treprostinil in Subjects With Idiopathic Pulmonary Fibrosis
· Phase 3
· completed
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by United Therapeutics
Last refreshed: 10 May 2021
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT01027949.