Phase 3
N=470
An Open-Label, Long-Term Study of Oral Treprostinil in Subjects With Pulmonary Arterial Hypertension
Pulmonary Arterial Hypertension
Bottom Line
View on ClinicalTrials.gov: NCT01560637 ↗Enrolled (actual)
470
Serious AEs
43.8%
Results posted
Jun 2022
Primary outcome: Primary: Number of Adverse Events — 450; 362; 126; 206 events
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- UT-15C (treprostinil diolamine) (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- United Therapeutics
- Primary completion
- Aug 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Adverse Events |
450; 362; 126; 206; 182; 67 | — |
| SECONDARY Change in 6-Minute Walk Distance From Baseline |
20.1 | — |
| SECONDARY Change in Borg Dyspnea Score From Baseline to Week 48 |
-0.49 | — |
| SECONDARY Change From Baseline to Week 48 in WHO Functional Class |
-0.2 | — |
| SECONDARY Change in N-terminal Pro-brain Natriuretic Peptide (NT-proBNP) From Baseline to Week 48 |
-179.23 | — |
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.
Eligibility Criteria
Inclusion Criteria
- 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.
Exclusion Criteria
- 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.
Data sourced from ClinicalTrials.gov (NCT01560637). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.