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Summary

for people ages 18–75 (full criteria)
at Fresno, California and other locations
study started
estimated completion:

Description

Summary

This study 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 currently receiving background oral monotherapy for at least 30 days at randomization for their PAH. Study visits will occur in four week intervals for the first 12 weeks, then every 12 weeks thereafter with key measures of efficacy being time to first clinical worsening event and the 6-minute walk test at Week 24. Study procedures include routine blood tests, medical history, physical exams, disease evaluation, and exercise tests. Patients who complete all required assessments will also be eligible to enter a long-term, open-label, extension study (TDE-PH-311).

Official Title

A Phase III, International, Multi-Center, Randomized, Double- Blind, Placebo-Controlled, Clinical Worsening Study of UT-15C in Subjects With Pulmonary Arterial Hypertension Receiving Background Oral Monotherapy

Keywords

Pulmonary Arterial Hypertension PAH PH Clinical Worsening Freedom Freedom-Ev Treprostinil UT-15C 6 Minute walk test Hypertension Familial Primary Pulmonary Hypertension

Eligibility

You can join if…

Open to people ages 18–75

  1. Between 18 and 75 years of age, inclusive
  2. PAH that is idiopathic / heritable, PAH associated with connective tissue disease, HIV infection, repaired congenital systemic-to-pulmonary shunts (repaired > 1 year), or appetite suppressant / toxin use
  3. Receiving one PAH-approved oral therapy at an appropriate dose
  4. Previous testing (e.g. right heart catheterization, echocardiography) consistent with diagnosis of PAH

You CAN'T join if...

  1. Nursing or pregnant
  2. PAH due to conditions other than noted in the above inclusion criteria
  3. History of uncontrolled sleep apnea, severe liver disease, left sided heart disease,uncontrolled systemic hypertension
  4. Use of an investigational drug or device within 30 days of Screening

Locations

  • University of California, San Francisco-Fresno accepting new patients
    Fresno, California, 93721, United States
  • University of California-Davis Medical Group, Advanced Lung Disease/Transplant Program accepting new patients
    Sacramento, California, 95817, United States
  • Cedars-Sinai Medical Center accepting new patients
    Los Angeles, California, 90211, United States
  • David Geffen School of Medicine completed
    Torrance, California, 90502, United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
United Therapeutics
ID
NCT01560624
Phase
Phase 3
Study Type
Interventional
Last Updated
November 3, 2017