| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01560637 | An Open-Label, Long-Term Study of Oral Treprostinil in Subjects With Pulmonary Arterial Hypertension | PHASE3 | COMPLETED | 471 | — | — | Sep 11, 2013 | Aug 12, 2021 | Jun 2, 2022 | 153 | United States, Argentina +21 |
| NCT01934582 | A Pharmacokinetic Substudy of the TDE-PH-304 Protocol | PHASE3 | COMPLETED | 13 | — | — | Aug 1, 2013 | Nov 1, 2013 | Jan 3, 2024 | 1 | United States |
| NCT01588405 | Remodulin® to Oral Treprostinil Transition | PHASE2 | COMPLETED | 33 | — | — | Apr 1, 2012 | Dec 1, 2014 | May 16, 2016 | 6 | United States |
| NCT01477333 | Addition of UT-15C SR to Pulmonary Arterial Hypertension Patients Currently Receiving Tyvaso® | PHASE2 | COMPLETED | 18 | — | — | Oct 1, 2011 | Nov 1, 2013 | Dec 27, 2023 | 6 | United States |
| NCT01131845 | The Effect of Renal Impairment on the Pharmacokinetics of Oral Treprostinil | PHASE1 | COMPLETED | 16 | — | — | May 1, 2010 | Sep 1, 2010 | May 17, 2012 | 1 | United States |
All subjects who received oral treprostinil in TDE-PH-311 were included in the Safety population. All AEs were captured from the time the ICF was signed. All AEs were followed until resolution (or return to normal or baseline values), until they were judged by the Investigator to no longer be clinically significant, or for up to 30 days if the AE extended beyond the final visit. All SAEs were followed until resolution, death, or the subject was lost to follow-up, even if they were ongoing more than 30 days after completion of the final visit. The overall summary of AEs includes the number of subjects with any AE, the number of subjects with any study drug-related AEs, the number of subjects with AEs leading to study drug withdrawal, the number of subjects with any serious AEs, the number of subjects with any severe AEs, and the number of subjects with any study drug-related severe/serious AEs. AEs were coded using the Medical Dictionary for Regulatory Activities.
The PK sampling occurred over a 12-hour period in subjects during BID dosing (PK Visit 1) and during TID dosing (PK Visit 2). Prior to each PK sampling day, subjects must have been receiving a stable dose for at least 5 days.
The PK sampling occurred over a 12-hour period in subjects during BID dosing (PK Visit 1) and during TID dosing (PK Visit 2). Prior to each PK sampling day, subjects must have been receiving a stable dose for at least 5 days.
The PK sampling occurred over a 12-hour period in subjects during BID dosing (PK Visit 1) and during TID dosing (PK Visit 2). Prior to each PK sampling day, subjects must have been receiving a stable dose for at least 5 days.
Successful transition was based on the number of participants that completely transitioned to oral treprostinil by the week 4 study visit and clinically maintained on oral treprostinil treatment through Week 24.
Hemodynamics (via right heart catheterization \[RHC\]) were assessed at Baseline and Week 24 or at the time of premature termination of study drug if prior to the Week 24 visit. Cardiopulmonary hemodynamic measurements included the following: mean pulmonary arterial pressure (PAPm), mean systemic arterial pressure (SAPm), mean right atrial pressure (RAPm), and mean pulmonary capillary wedge pressure (PCWPm).
Heart rate was assessed at Baseline and Week 24 or at the time of premature termination of study drug if prior to the Week 24 visit.
Hemodynamics (via right heart catheterization \[RHC\]) were assessed at Baseline and Week 24 or at the time of premature termination of study drug if prior to the Week 24 visit. Cardiopulmonary hemodynamic measurements included arterial oxygen saturation (SaO2) and mixed venous oxygen saturation (SvO2).
Hemodynamics (via right heart catheterization \[RHC\]) were assessed at Baseline and Week 24 or at the time of premature termination of study drug if prior to the Week 24 visit.
Hemodynamics (via right heart catheterization \[RHC\]) were assessed at Baseline and Week 24 or at the time of premature termination of study drug if prior to the Week 24 visit. Cardiopulmonary hemodynamic measurements included cardiac index (CI).
Hemodynamics (via right heart catheterization \[RHC\]) were assessed at Baseline and Week 24 or at the time of premature termination of study drug if prior to the Week 24 visit. Cardiopulmonary hemodynamic measurements included the following: pulmonary vascular resistance index (PVRI).
| Arm | Type | Description |
|---|---|---|
| UT-15C | EXPERIMENTAL | Open label access |
| Open label extension | EXPERIMENTAL | - |
| UT-15C SR | EXPERIMENTAL | - |
| UT-15C SR BID | EXPERIMENTAL | Initiated at 0.125 mg twice daily (BID), titrated as clinically indicated. |
| Treprostinil diethanolamine | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| UT-15C (treprostinil diolamine) | DRUG | UT-15C extended release oral tablet three times daily |
| UT-15C SR | DRUG | - |
| treprostinil diethanolamine | DRUG | Open label study drug. |
| Tyvaso Inhalation Solution | DRUG | Administered as at least 9 breaths 4 times daily for at least 4 weeks prior to Baseline |
| UT-15C SR (treprostinil diethanolamine) | DRUG | Single dose, 1 mg UT-15C SR |
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 ...