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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

Tracking Information
First Submitted Date  ICMJE March 9, 2012
First Posted Date  ICMJE March 22, 2012
Results First Submitted Date  ICMJE April 7, 2022
Results First Posted Date  ICMJE June 2, 2022
Last Update Posted Date June 2, 2022
Actual Study Start Date  ICMJE September 11, 2013
Actual Primary Completion Date August 12, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 6, 2022)
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.
Original 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 ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 6, 2022)
  • 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.
  • 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).
  • 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.
  • 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)
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures 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  ICMJE Phase 3
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Pulmonary Arterial Hypertension
Intervention  ICMJE Drug: UT-15C (treprostinil diolamine)
UT-15C extended release oral tablet three times daily
Study Arms  ICMJE Experimental: UT-15C
Open label access
Intervention: Drug: UT-15C (treprostinil diolamine)
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 Completed
Actual Enrollment  ICMJE
 (submitted: June 15, 2020)
471
Original Estimated Enrollment  ICMJE
 (submitted: March 20, 2012)
858
Actual Study Completion Date  ICMJE August 12, 2021
Actual Primary Completion Date August 12, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE 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
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01560637
Other Study ID Numbers  ICMJE TDE-PH-311
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party United Therapeutics
Original Responsible Party Same as current
Current Study Sponsor  ICMJE United Therapeutics
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account United Therapeutics
Verification Date May 2022

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