Trial record 2 of 2 for:    tde-ph-311

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 September 2014 by United Therapeutics
Sponsor:
Information provided by (Responsible Party):
United Therapeutics
ClinicalTrials.gov Identifier:
NCT01560637
First received: March 9, 2012
Last updated: September 9, 2014
Last verified: September 2014

March 9, 2012
September 9, 2014
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 ] [ Designated as safety issue: No ]
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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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
858
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
Both
18 Years to 75 Years
No
United States,   Argentina,   Australia,   Austria,   Brazil,   Canada,   China,   France,   Germany,   Israel,   Italy,   Korea, Republic of,   Mexico,   Netherlands,   Singapore,   Sweden,   Taiwan,   United Kingdom
 
NCT01560637
TDE-PH-311
Yes
United Therapeutics
United Therapeutics
Not Provided
Not Provided
United Therapeutics
September 2014

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