Phase 2
Completed N=18
Addition of UT-15C SR to Pulmonary Arterial Hypertension Patients Currently Receiving Tyvaso®
Source: ClinicalTrials.gov NCT01477333 ↗Enrolled (actual)
18
Serious AEs
11.1%
Results posted
Mar 2017
Primary outcomePrimary: Change in Hemodynamic Parameters From Baseline to Week 24. — -2.0; 0; -1.0; 3.0 mmHg
Summary
The purpose of this multi-center, open-label, safety and tolerability study was to assess the addition of oral treprostinil (UT-15C sustained release [SR] tablets) to subjects currently receiving Tyvaso (treprostinil) inhalation solution. During the 24-week evaluation period, the study evaluated the changes in the following assessments: hemodynamics, 6-minute walk test (6MWT), Borg dyspnea score, N-Terminal pro-brain natriuretic peptide (NT-proBNP), World Health Organization (WHO) Functional Class, and safety assessments.
Eligible subjects had a diagnosis of pulmonary arterial hypertension (PAH), currently were receiving Tyvaso, and may have been receiving other approved PAH specific oral therapies (endothelin receptor antagonists [ERAs] and/or phosphodiesterase type 5 inhibitor [PDE5-I], if at a stable dose for ≥30 days). At Baseline, subjects received the first dose of 0.125 mg UT-15C SR.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Hemodynamic Parameters From Baseline to Week 24. |
-2.0; 0; -1.0; 3.0; 0; 0 | — |
| PRIMARY Change in Hemodynamic Parameter (Heart Rate) From Baseline to Week 24. |
4.00 | — |
| PRIMARY Change in Hemodynamic Parameters (Arterial and Venous Oxygen Saturation) From Baseline to Week 24. |
1.0; 0 | — |
| PRIMARY Change in Hemodynamic Parameter (Cardiac Output) From Baseline to Week 24. |
— | — |
| PRIMARY Change in Hemodynamic Parameter (Cardiac Index) From Baseline to Week 24. |
— | — |
| PRIMARY Change in Hemodynamic Parameter (Pulmonary Vascular Resistance Index) From Baseline to Week 24. |
0.2 | — |
| SECONDARY Change in Exercise Capacity as Measured by the 6-minute Walk Test (6MWT) Over the 24-week Treatment Period. |
20.5; 12.4; 14.9 | — |
| SECONDARY Time to Clinical Worsening Over the Treatment Period. |
234 | — |
| SECONDARY Shift From Baseline in World Health Organization (WHO) Functional Class Over the 24-week Treatment Period. |
8; 1; 0; 9; 6; 3 | — |
| SECONDARY N-terminal Pro-Brain Natriuretic Peptide (NT-proBNP) Over the 24-week Treatment Period. |
-99; 144 | — |
Eligibility Criteria
Significant inclusion criteria included:
- Subjects were between 18 to 75 years of age
- Diagnosis of PAH: Idiopathic; Heritable; Associated with: Collagen vascular disease, Human immunodeficiency virus (HIV) infection, appetite suppressant or toxin use, or repaired congenital systemic-to-pulmonary shunts (repaired ≥5 years)
- Had been receiving Tyvaso for at least 4 weeks (≥9 breaths, 4 times a day [QID]) and required additional therapy
- In addition to Tyvaso, subjects may have been receiving other approved PAH specific oral therapies (ERAs and/or PDE-5 inhibitors, if at a stable dose)
Significant exclusion criteria included:
- The subject was pregnant or lactating
- The subject had previously received UT-15C SR
- The subject had added, discontinued or changed the dosing regimen (i.e., prescription) of conventional PAH therapies (e.g., oral vasodilators, oxygen, digoxin) within 21 days of Baseline
- The subject was receiving a FDA approved PAH therapy (e.g., ERA and/or PDE-5 inhibitor) for less than 30 days prior to Baseline, or the dose had been modified within 30 days of Baseline
- The subject had any disease associated with PAH other than collagen vascular disease, HIV infection, repaired congenital systemic-to-pulmonary shunts (for at least 5 years), or appetite suppressant/toxin use (e.g., portal hypertension, chronic thromboembolic disease, pulmonary veno-occlusive disease, etc.), or had an atrial septostomy
- The subject had ischemic heart disease prior to Screening, or left ventricular dysfunction as evidenced by a mean PCWP (or a left ventricular end diastolic pressure) greater than 15 mmHg or left ventricular ejection fraction (LVEF) less than 40% as assessed by either multigated angiogram (MUGA), angiography or echocardiography. Patients with abnormal left ventricular function attributable entirely to impaired left ventricular filling due to the effects of right ventricular overload were not excluded.
- The subject had uncontrolled systemic hypertension as evidenced by systolic blood pressure greater than 160 mmHg or diastolic blood pressure greater than 100 mmHg at Baseline.
Data sourced from ClinicalTrials.gov (NCT01477333). 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. Informational only — not medical advice.