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An Open-Label, Long-Term Study of Oral Treprostinil in Subjects With Pulmonary Arterial Hypertension

This study is currently recruiting participants.
Verified November 2016 by United Therapeutics
Sponsor:
ClinicalTrials.gov Identifier:
NCT01560637
First Posted: March 22, 2012
Last Update Posted: November 17, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
United Therapeutics
  Purpose
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.

Condition Intervention Phase
Pulmonary Arterial Hypertension Drug: UT-15C (treprostinil diethanolamine) Phase 3

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by United Therapeutics:

Primary Outcome Measures:
  • Safety (e.g.number and frequency of adverse events, changes in laboratory parameters from Baseline) [ Time Frame: participants will be followed every 12 weeks, at minimum, until they discontinue the study or the study is discontinued by the sponsor or for a period up to 2.5 years ]

Estimated Enrollment: 850
Study Start Date: May 2012
Estimated Study Completion Date: August 2021
Estimated Primary Completion Date: May 2021 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: UT-15C
Open label access
Drug: UT-15C (treprostinil diethanolamine)
UT-15C sustained release oral tablet for three times daily administration

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Participated in United Therapeutics Study TDE-PH-310

Exclusion Criteria:

  • Premature discontinuation of United Therapeutics Study TDE-PH-310 due to reasons other than clinical worsening
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01560637


  Show 152 Study Locations
Sponsors and Collaborators
United Therapeutics
  More Information

Responsible Party: United Therapeutics
ClinicalTrials.gov Identifier: NCT01560637     History of Changes
Other Study ID Numbers: TDE-PH-311
First Submitted: March 9, 2012
First Posted: March 22, 2012
Last Update Posted: November 17, 2016
Last Verified: November 2016

Keywords provided by United Therapeutics:
PAH
PH
FREEDOM
6 minute walk test
treprostinil
open label

Additional relevant MeSH terms:
Hypertension
Familial Primary Pulmonary Hypertension
Vascular Diseases
Cardiovascular Diseases
Hypertension, Pulmonary
Lung Diseases
Respiratory Tract Diseases
Treprostinil
Antihypertensive Agents


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