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

This study is not yet open for participant recruitment.

Verified March 2012 by United Therapeutics

Sponsor:

Information provided by (Responsible Party):

United Therapeutics

ClinicalTrials.gov Identifier:

NCT01560637

First received: March 9, 2012

Last updated: March 20, 2012

Last verified: March 2012

History of Changes

Tracking Information
First Received Date ^ICMJE	March 9, 2012
Last Updated Date	March 20, 2012
Start Date ^ICMJE	May 2012
Estimated Primary Completion Date	May 2021 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: March 20, 2012)	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 ]
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT01560637 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE	Not Provided
Original Secondary Outcome Measures ^ICMJE	Not Provided
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	An Open-Label, Long-Term Study of Oral Treprostinil in Subjects With Pulmonary Arterial Hypertension
Official Title ^ICMJE	Open-Label Extension Study of UT-15C in Subjects With Pulmonary Arterial Hypertension- A Long-Term Follow-Up to Protocol TDE-PH-310
Brief 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.
Detailed Description	Not Provided
Study Type ^ICMJE	Interventional
Study Phase	Phase 3
Study Design ^ICMJE	Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Condition ^ICMJE	Pulmonary Arterial Hypertension
Intervention ^ICMJE	Drug: UT-15C (treprostinil diethanolamine) UT-15C sustained release oral tablet for twice daily administration
Study Arm (s)	Experimental: UT-15C Open label access Intervention: Drug: UT-15C (treprostinil diethanolamine)
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Not yet recruiting
Estimated Enrollment ^ICMJE	858
Estimated Completion Date	August 2021
Estimated Primary Completion Date	May 2021 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	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
Gender	Both
Ages	18 Years to 75 Years
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Not Provided
Location Countries ^ICMJE	Not Provided

Administrative Information
NCT Number ^ICMJE	NCT01560637
Other Study ID Numbers ^ICMJE	TDE-PH-311
Has Data Monitoring Committee	Yes
Responsible Party	United Therapeutics
Study Sponsor ^ICMJE	United Therapeutics
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	United Therapeutics
Verification Date	March 2012
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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