Addition of UT-15C SR to Pulmonary Arterial Hypertension Patients Currently Receiving Tyvaso®
Condition: Pulmonary Arterial Hypertension
MeSH terms: Pulmonary Arterial Hypertension; Familial Primary Pulmonary Hypertension; Hypertension
Intervention: UT-15C SR; Tyvaso Inhalation Solution
Intervention description: Initiated at 0.125 mg BID, titrated as clinically indicated.; Administered as at least 9 breaths 4 times daily for at least 4 weeks prior to Baseline
Intervention MeSH terms: Treprostinil
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 18.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: Tyvaso; UT-15C SR; PAH

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.
    

Eligibility criteria:

        Significant inclusion criteria included:

          1. Subjects were between 18 to 75 years of age

          2. 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)

          3. Had been receiving Tyvaso for at least 4 weeks (≥9 breaths, 4 times a day [QID]) and
             required additional therapy

          4. 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:

          1. The subject was pregnant or lactating

          2. The subject had previously received UT-15C SR

          3. 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

          4. 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

          5. 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

          6. 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.

          7. 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.