At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 471 enrolled
Drug / intervention
UT-15C (treprostinil diolamine)drug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Open-Label Extension Study of UT-15C in Subjects With Pulmonary Arterial Hypertension- A Long-Term Follow-Up to Protocol TDE-PH-310
In Brief
A Phase 3 clinical trial evaluating UT-15C (treprostinil diolamine) for Pulmonary Arterial Hypertension. Completed, enrolled 471 participants across 153 sites in 23 countries.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPulmonary Arterial Hypertension
CountriesArgentina, Australia, Austria, Brazil, Canada, Chile, China, Denmark, France, Germany, Greece, India, Israel, Italy, Mexico, Netherlands, Poland, Singapore, South Korea, Sweden, Taiwan, United Kingdom, United States
Collaborators--
Timeline
Phase 3CompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedMar 2012
Enrollment StartSep 2013
Primary CompletionAug 2021
TodayJul 2026
First PostedMar 22, 2012
Enrollment StartSep 11, 2013
Primary CompletionAug 12, 2021
TodayJul 2, 2026
Enrollment to primary: 7.9 yearsPosted 14.3 years ago
Interventions
UT-15C (treprostinil diolamine)drug
UT-15C extended release oral tablet three times daily