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Summary

for people ages 12 years and up (full criteria)
at Fresno, California and other locations
study started

Description

Summary

This study provides, or continues to provide, UT-15C SR (treprostinil diethanolamine) to eligible patients with pulmonary arterial hypertension who have completed protocols TDE-PH-202, TDE-PH-203, TDE-PH-205, TDE-PH-301, TDE-PH-302, TDE-PH-308 studies or any additional UT-15C SR clinical protocols evaluating subjects with PAH. The study assesses the long term safety of UT-15C and the effect of continued treatment with UT-15C on exercise capacity after one year of treatment.

Details

This is an open-label study. Each subject's visit schedule will allow assessments after defined periods of exposure to UT-15C SR (3, 6, 12, 24 and 36 months total exposure). The study will continue with yearly visits beyond 36 months until either UT-15C SR is approved by the appropriate regulatory authorities or the study is discontinued by the sponsor. Therefore, the actual date of each visit will be determined by the date on which the subject first received UT-15C SR (e.g., the date of study drug initiation in TDE-PH- 301, TDE-PH-302, or TDE-PH-308 for subjects who were randomized to active therapy in those trials,and the date of UT-15C SR initiation in this study for subjects who were randomized to placebo in the previous controlled trial). Note that the TDE-PH-202, TDE-PH-203, TDE-PH-205 studies are open-label design and therefore will follow the regimen for subjects receiving UT-15C SR.

Keywords

Pulmonary Arterial Hypertension Hypertension Familial Primary Pulmonary Hypertension Treprostinil

Eligibility

For people ages 12 years and up

Participation in study TDE-PH-202, TDE-PH-203, TDE-PH-205, TDE-PH-301,TDE-PH-302,TDE-PH-308 or any additional UT-15C SR clinical protocol is required. Subjects must complete all assessments in one of these studies to be eligible.

Locations

  • University of California, San Francisco-Fresno
    Fresno, California, 93701, United States
  • Stanford University, Pulmonary and Critical Care
    Stanford, California, 94305-5351, United States
  • UC Davis Medical Center
    Sacramento, California, 95817, United States
  • Harbor-UCLA Medical Center
    Torrance, California, 90502, United States
  • West Los Angeles VA Healthcare Center
    Los Angeles, California, 90073, United States

Details

Status
in progress, not accepting new patients
Start Date
Sponsor
United Therapeutics
ID
NCT01027949
Phase
Phase 3
Lead Scientist
Study Type
Interventional
Last Updated
November 17, 2016