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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
March 9, 2012
March 22, 2012
November 17, 2016
May 2012
May 2021   (Final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT01560637 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
An Open-Label, Long-Term Study of Oral Treprostinil in Subjects With Pulmonary Arterial Hypertension
Open-Label Extension Study of UT-15C in Subjects With Pulmonary Arterial Hypertension- A Long-Term Follow-Up to Protocol TDE-PH-310
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.
Not Provided
Interventional
Phase 3
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Pulmonary Arterial Hypertension
Drug: UT-15C (treprostinil diethanolamine)
UT-15C sustained release oral tablet for three times daily administration
Experimental: UT-15C
Open label access
Intervention: Drug: UT-15C (treprostinil diethanolamine)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
850
August 2021
May 2021   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years to 75 Years   (Adult, Senior)
No
Argentina,   Australia,   Austria,   Brazil,   Canada,   Chile,   China,   Denmark,   France,   Germany,   Greece,   India,   Israel,   Italy,   Korea, Republic of,   Mexico,   Netherlands,   Poland,   Singapore,   Sweden,   Taiwan,   United Kingdom,   United States
 
 
NCT01560637
TDE-PH-311
Yes
Not Provided
Not Provided
United Therapeutics
United Therapeutics
Not Provided
Not Provided
United Therapeutics
November 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP