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

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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01560637
Recruitment Status : Completed
First Posted : March 22, 2012
Results First Posted : June 2, 2022
Last Update Posted : June 2, 2022
Sponsor:
Information provided by (Responsible Party):
United Therapeutics

Study Description
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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.

Condition or disease Intervention/treatment Phase
Pulmonary Arterial Hypertension Drug: UT-15C (treprostinil diolamine) Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 471 participants
Allocation: N/A
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
Actual Study Start Date : September 11, 2013
Actual Primary Completion Date : August 12, 2021
Actual Study Completion Date : August 12, 2021

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: UT-15C
Open label access
 Drug: UT-15C (treprostinil diolamine)
UT-15C extended release oral tablet three times daily


Outcome Measures
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Primary Outcome Measures :
  1. Number of Adverse Events [ 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 ]
    All subjects who received oral treprostinil in TDE-PH-311 were included in the Safety population. All AEs were captured from the time the ICF was signed. All AEs were followed until resolution (or return to normal or baseline values), until they were judged by the Investigator to no longer be clinically significant, or for up to 30 days if the AE extended beyond the final visit. All SAEs were followed until resolution, death, or the subject was lost to follow-up, even if they were ongoing more than 30 days after completion of the final visit. The overall summary of AEs includes the number of subjects with any AE, the number of subjects with any study drug-related AEs, the number of subjects with AEs leading to study drug withdrawal, the number of subjects with any serious AEs, the number of subjects with any severe AEs, and the number of subjects with any study drug-related severe/serious AEs. AEs were coded using the Medical Dictionary for Regulatory Activities.


Secondary Outcome Measures :
  1. Change in 6-Minute Walk Distance From Baseline [ Time Frame: Baseline to Week 48 ]
    A summary of change from Baseline in 6MWD at Week 48 for the Safety Population is provided. The Safety Population is all subjects who received oral treprostinil in TDE-PH-311.

  2. Change in Borg Dyspnea Score From Baseline to Week 48 [ Time Frame: Baseline to Week 48 ]

    Change in Borg Dyspnea Score from at Week 48 is provided for the Safety Population (all subjects who received oral treprostinil in TDE-PH-311).

    The Borg Dyspnea Scale is a 0 to 10 rated numerical score used to measure dyspnea as reported by the patient during submaximal exercise and was administered during six-minute walk testing (6MWT), one of the most common and frequently used measures to assess disease severity in PAH. The numbers on the scale are as follows: 0 (no shortness of breath [SOB]), 0.5 (very very slight SOB), 1 (very slight SOB), 3 (moderate SOB), 4 (somewhat severe SOB), 5 (severe SOB), 7 (very severe SOB), 9 (very very severe SOB), 10 (maximal SOB).


  3. Change From Baseline to Week 48 in WHO Functional Class [ Time Frame: Baseline to Week 48 ]

    Change from Baseline at Week 48 in WHO FC in the Safety Population (all subjects who received oral treprostinil in TDE-PH-311).

    The World Health Organization functional classification (WHO-FC) is a clinician-rated assessment used widely to assess PAH severity and functioning.

    Class I (least severe): Patients are without limitation of physical activity.

    Class II: Patients are comfortable at rest. Ordinary physical activity causes undue dyspnea or fatigue, chest pain or near syncope.

    Class III: Marked limitation of physical activity. They are comfortable at rest.

    Class IV (most severe): Inability to carry out any physical activity without symptoms. These patients manifest signs of right heart failure.


  4. Change in N-terminal Pro-brain Natriuretic Peptide (NT-proBNP) From Baseline to Week 48 [ Time Frame: Baseline to Week 48 ]
    Change in N-terminal pro-brain natriuretic peptide from Baseline at Week 48 for the Safety Population (any subject who received oral treprostinil in TDE-PH-311)


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

Inclusion Criteria:

  • Participated in United Therapeutics Study TDE-PH-310
  • All women of childbearing potential (WOCBP) must have practiced true abstinence from intercourse when it was in line with their preferred and usual lifestyle or used 2 different forms of highly effective contraception for the duration of the study and for at least 30 days after discontinuing study medication.
  • Males who participated in the study must have used a condom during the length of the study and for at least 48 hours after their last dose of study medication.

Exclusion Criteria:

  • The subject was pregnant or lactating.
  • The subject had received infused or inhaled prostacyclin therapy for 29 days or more.
  • The subject was prematurely discontinued from TDE-PH-310 for reasons other than a clinical worsening event.
  • The subject developed a concurrent illness or condition during the conduct of TDE-PH-310 which, in the opinion of the Investigator, would represent a risk to their overall health if they enrolled in this study.
Contacts and Locations
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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


Locations
Show Show 153 study locations
Sponsors and Collaborators
United Therapeutics
  Study Documents (Full-Text)

Documents provided by United Therapeutics:
Study Protocol  [PDF] July 13, 2018
Statistical Analysis Plan  [PDF] January 15, 2019
Informed Consent Form  [PDF] July 13, 2018

More Information
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Responsible Party: United Therapeutics
ClinicalTrials.gov Identifier: NCT01560637    
Other Study ID Numbers: TDE-PH-311
First Posted: March 22, 2012    Key Record Dates
Results First Posted: June 2, 2022
Last Update Posted: June 2, 2022
Last Verified: May 2022
Keywords provided by United Therapeutics:
PAH
PH
FREEDOM
 6 minute walk test
treprostinil
open label
Additional relevant MeSH terms:
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Pulmonary Arterial Hypertension
Familial Primary Pulmonary Hypertension
Hypertension
Vascular Diseases
Cardiovascular Diseases
 Hypertension, Pulmonary
Lung Diseases
Respiratory Tract Diseases
Treprostinil
Antihypertensive Agents