Summary

for people ages 18-75 (full criteria)
at UCSF UC Davis
study started
estimated completion:
Vijay Balasubramanian (ucsf) Roblee Allen (ucdavis)

Description

Summary

This study is an international, multi-center, open-label study designed to provide oral treprostinil (UT-15C) to eligible subjects with pulmonary arterial hypertension who have completed the TDE-PH-310 study. The purpose of this study is to assess the long-term safety of UT-15C and to assess the effects of long-term treatment with UT-15C on exercise capacity.

Official Title

Open-Label Extension Study of UT-15C in Subjects With Pulmonary Arterial Hypertension- A Long-Term Follow-Up to Protocol TDE-PH-310

Keywords

Pulmonary Arterial Hypertension PAH PH FREEDOM 6 minute walk test treprostinil open label Hypertension Familial Primary Pulmonary Hypertension UT-15C (treprostinil diethanolamine)

Eligibility

You can join if…

Open to people ages 18-75

  • Participated in United Therapeutics Study TDE-PH-310

You CAN'T join if...

  • Premature discontinuation of United Therapeutics Study TDE-PH-310 due to reasons other than clinical worsening

Locations

  • University of California, San Francisco-Fresno accepting new patients
    Fresno California 93701 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

Lead Scientists

  • Vijay Balasubramanian (ucsf)
    Vijay Balasubramanian, M.D. Clinical Professor, UCSF Medical Director of Pulmonary Hypertension-Community Regional Medical Center Vijay Balasubramanian, M.D., specializes in pulmonary disease. He is board certified in Internal Medicine. His residency and fellowship training were completed at the Medical College of Wisconsin.
  • Roblee Allen (ucdavis)
    Professor, Pulmonary, Critical Care, and Sleep Medicine

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
United Therapeutics
ID
NCT01560637
Phase
Phase 3
Study Type
Interventional
Last Updated