An Open-Label, Long-Term Study of Oral Treprostinil in Subjects With Pulmonary Arterial Hypertension

Completed · Phase 3

Conditions studied: Pulmonary Arterial Hypertension

In brief

This study is an international, multi-center, open-label study designed to provide oral treprostinil (UT-15C) to eligible subjects with pulmonary arterial hypertension who have completed the TDE-PH-310 study. The purpose of this study is to assess the long-term safety of UT-15C and to assess the effects of long-term treatment with UT-15C on exercise capacity.

Key facts

Study ID

NCT01560637

Run by

United Therapeutics

People needed

471

Starts

2013-09-11

Expected to finish

2021-08-12

Last updated by the study team

2022-06-02

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Participated in United Therapeutics Study TDE-PH-310
• All women of childbearing potential (WOCBP) must have practiced true abstinence from intercourse when it was in line with their preferred and usual lifestyle or used 2 different forms of highly effective contraception for the duration of the study and for at least 30 days after discontinuing study medication.
• Males who participated in the study must have used a condom during the length of the study and for at least 48 hours after their last dose of study medication.

You may not qualify if…

• The subject was pregnant or lactating.
• The subject had received infused or inhaled prostacyclin therapy for 29 days or more.
• The subject was prematurely discontinued from TDE-PH-310 for reasons other than a clinical worsening event.
• The subject developed a concurrent illness or condition during the conduct of TDE-PH-310 which, in the opinion of the Investigator, would represent a risk to their overall health if they enrolled in this study.

Where it is running

• University of Arizona — Tucson, Arizona, United States
• University of California, San Francisco-Fresno — Fresno, California, United States
• Cedars-Sinai Medical Center — Los Angeles, California, United States
• University of California-Davis Medical Group, Advanced Lung Disease/Transplant Program — Sacramento, California, United States
• David Geffen School of Medicine — Torrance, California, United States
• University of Colorado Hospital — Aurora, Colorado, United States
• University of Florida — Gainesville, Florida, United States
• University of Florida College of Medicine Jacksonville- Division of Pulmonary & Critical Medicine — Jacksonville, Florida, United States
• Cleveland Clinic Florida — Weston, Florida, United States
• Emory University Hospital — Atlanta, Georgia, United States
• Augusta University — Augusta, Georgia, United States
• Piedmont - Georgia Lung Associates — Austell, Georgia, United States
• HeartCare Midwest — Peoria, Illinois, United States
• Indiana University Hospital — Carmel, Indiana, United States
• University of Iowa Hospitals and Clinics — Iowa City, Iowa, United States
• Kentuckiana Pulmonary Associates — Louisville, Kentucky, United States
• University of Maryland — Baltimore, Maryland, United States
• Tufts Medical Center — Boston, Massachusetts, United States
• Massachusetts General Hospital — Boston, Massachusetts, United States
• Henry Ford Health System — Detroit, Michigan, United States
• Beaumont Health — Troy, Michigan, United States
• Nebraska Medical Center — Omaha, Nebraska, United States
• Newark Beth Israel Medical Center — Newark, New Jersey, United States
• University of Rochester — Rochester, New York, United States
• Arizona Pulmonary Specialists, Ltd. — Phoenix, Arizona, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.