NCT01560637

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

Open-Label Extension Study of UT-15C in Subjects With Pulmonary Arterial Hypertension- A Long-Term Follow-Up to Protocol TDE-PH-310

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 471 (actual)
• Sponsor: United Therapeutics · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Pulmonary Arterial Hypertension

Interventions

Type	Name	Description
DRUG	UT-15C (treprostinil diolamine)	UT-15C extended release oral tablet three times daily

Timeline

• Start date: 2013-09-11
• Primary completion: 2021-08-12
• Completion: 2021-08-12
• First posted: 2012-03-22
• Last updated: 2022-06-02
• Results posted: 2022-06-02

Locations

153 sites across 23 countries: United States, Argentina, Australia, Austria, Brazil, Canada, Chile, China, Denmark, France, Germany, Greece, India, Israel, Italy, Mexico, Netherlands, Poland, Singapore, South Korea, Sweden, Taiwan, United Kingdom