Trial record 1 of 2 for:    TDE-PH-310
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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. (see Contacts and Locations)
Verified June 2014 by United Therapeutics
Sponsor:
Information provided by (Responsible Party):
United Therapeutics
ClinicalTrials.gov Identifier:
NCT01560637
First received: March 9, 2012
Last updated: June 24, 2014
Last verified: June 2014
  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: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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 ] [ Designated as safety issue: No ]

Estimated Enrollment: 858
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

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01560637

  Show 91 Study Locations
Sponsors and Collaborators
United Therapeutics
  More Information

No publications provided

Responsible Party: United Therapeutics
ClinicalTrials.gov Identifier: NCT01560637     History of Changes
Other Study ID Numbers: TDE-PH-311
Study First Received: March 9, 2012
Last Updated: June 24, 2014
Health Authority: United States: Food and Drug Administration

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

Additional relevant MeSH terms:
Hypertension, Pulmonary
Hypertension
Lung Diseases
Respiratory Tract Diseases
Vascular Diseases
Cardiovascular Diseases
Treprostinil
Antihypertensive Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 28, 2014