Phase III Clinical Worsening Study of UT-15C in Subjects With PAH Receiving Background Oral Monotherapy
Condition: Pulmonary Arterial Hypertension
MeSH terms: Pulmonary Arterial Hypertension; Familial Primary Pulmonary Hypertension; Hypertension
Study type: Interventional
Phase: Phase 3

Summary: 
      This is an international, multicenter, randomized, double-blind, placebo-controlled, event
      driven study in subjects with pulmonary arterial hypertension.
    

Detailed description: 
      Study TDE-PH-310 is an international, multicenter, randomized (1:1 oral treprostinil
      (UT-15C): placebo), double-blind, placebo-controlled study in subjects with pulmonary
      arterial hypertension (PAH) who are receiving background oral monotherapy for PAH for at
      least 30 days at randomization. Subjects are randomly allocated to receive oral treprostinil
      extended-release tablets or placebo by a stratified randomization by type of background
      therapy (Strata 1: phosphodiesterase type 5 inhibitor [PDE5-I] or soluble guanylate cyclase
      [sGC] stimulator; Strata 2: endothelin receptor antagonist [ERA]. Subjects are also
      stratified by baseline 6-minute walk distance (6MWD) less than or equal to 350 m or greater
      than 350 m. Subjects receive their first dose of study drug (0.125 mg) or matching placebo on
      the day of randomization. Oral dosing of study drug is continued at 0.125 mg 3 times daily
      (TID; every 6 to 8 hours) with food. The dose (or matching placebo) is titrated throughout
      the study up to a maximum dose of 12 mg TID to reach and maintain a tolerated dosing regimen
      that provided optimal clinical benefit. Once randomized, subjects return for study visits
      every 4 weeks for the first 12 weeks, then every 12 weeks for the duration of the study.
      Subjects continue in the study until experiencing clinical worsening, the number of
      adjudicated events necessary for study closure occurr, or prematurely discontinue
      participation in the study for any reason other than protocol-specified clinical worsening.
      At each scheduled visit, subjects undergo efficacy assessments for clinical worsening,
      exercise capacity (6MWD and Borg dyspnea score), WHO functional class (FC), and plasma
      N-Terminal pro-brain natriuretic peptide (NT-proBNP). Subjects could participate in an
      optional hemodynamic sub-study (assessed by RHC). Safety assessments consist of adverse
      events (AEs), physical examinations, vital signs, 12-lead electrocardiograms (ECGs), and
      clinical laboratory parameters. Patients who complete all required assessments are eligible
      to enter a long-term, open-label, extension study (TDE-PH-311).
    

Intervention name(s): Treprostinil Diolamine; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Active; Placebo
Other intervention name(s): UT--15C
Intervention MeSH terms: Treprostinil
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Pulmonary arterial hypertension (PAH); Pulmonary hypertension (PH); Clinical Worsening; Freedom; Freedom-EV; Treprostinil; UT-15C; 6 Minute walk test