FREEDOM-C: Oral Treprostinil in Combination With an Endothelin Receptor Antagonist (ERA) and/or a Phosphodiesterase-5 (PDE-5) Inhibitor for the Treatment of Pulmonary Arterial Hypertension (PAH)
Condition: Pulmonary Hypertension
MeSH terms: Hypertension, Pulmonary; Pulmonary Arterial Hypertension; Hypertension
Intervention: Oral treprostinil (UT-15C) sustained release tablets; Placebo
Intervention description: UT-15C 0.25, 0.5, 1, or 5 mg oral tablets by mouth every 12 hours; Placebo 0.25, 0.5, 1, or 5 mg oral tablets by mouth every 12 hours
Intervention MeSH terms: Treprostinil
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 354.0
Sex: All
Minimum age: 12 Years
Maximum age: 70 Years
Healthy volunteers: No
Keywords: Pulmonary Arterial Hypertension

Summary:

      This study was an international, multi-center, randomized, double-blind, placebo-controlled
      study in subjects with PAH who were currently receiving approved therapy for their PAH (i.e.,
      endothelin receptor antagonist and/or phosphodiesterase-5 inhibitor). Study visits occurred
      at 4 week intervals for 16 weeks; the key measure of efficacy was the 6-minute walk test.
      Study procedures included routine blood tests, medical history, physical exams, disease
      evaluation, and exercise tests. One optional substudy was also a part of FREEDOM-C at select
      centers - a hemodynamic substudy with a right heart catheterization at Baseline and Week 16.

      Patients who completed all assessments for 16-weeks were also eligible to enter an
      open-label, extension phase study (FREEDOM - EXT).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Between 12 and 70 years of age, inclusive.

          -  Body weight at least 45 kg (approximately 100 pounds).

          -  PAH that is either idiopathic/heritable (including PAH associated with appetite
             suppressant/toxin use); PAH associated with repaired congenital systemic-to-pulmonary
             shunts (repaired ≥ 5 years); PAH associated with collagen vascular disease; or PAH
             associated with HIV.

          -  Baseline 6-minute walk distance between 150 and 450 meters, inclusive.

          -  Currently receiving an approved endothelin receptor antagonist and/or an approved
             phosphodiesterase-5 inhibitor for at least 90 days and on a stable dose for at least
             the last 30 days.

          -  Previous testing (e.g., right heart catheterization, echocardiography) consistent with
             the diagnosis of PAH.

          -  Reliable and cooperative with protocol requirements.

        Exclusion Criteria:

          -  Nursing or pregnant.

          -  Received a prostacyclin within the past 30 days.

          -  PAH due to conditions other than noted in the above inclusion criteria.

          -  History of uncontrolled sleep apnea, renal insufficiency, anemia, left sided heart
             disease, uncontrolled systemic hypertension, or parenchymal lung disease.

          -  Use of an investigational drug within 30 days of Baseline.