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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT01560637
Registration number
NCT01560637
Ethics application status
Date submitted
9/03/2012
Date registered
22/03/2012
Date last updated
2/06/2022
Titles & IDs
Public title
An Open-Label, Long-Term Study of Oral Treprostinil in Subjects With Pulmonary Arterial Hypertension
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Scientific title
Open-Label Extension Study of UT-15C in Subjects With Pulmonary Arterial Hypertension- A Long-Term Follow-Up to Protocol TDE-PH-310
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Secondary ID [1]
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0
TDE-PH-311
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Pulmonary Arterial Hypertension
0
0
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Condition category
Condition code
Respiratory
0
0
0
0
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Other respiratory disorders / diseases
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Human Genetics and Inherited Disorders
0
0
0
0
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Other human genetics and inherited disorders
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Cardiovascular
0
0
0
0
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Hypertension
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - UT-15C (treprostinil diolamine)
Experimental: UT-15C - Open label access
Treatment: Drugs: UT-15C (treprostinil diolamine)
UT-15C extended release oral tablet three times daily
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Intervention code [1]
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0
Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Number of Adverse Events
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Assessment method [1]
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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.
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Timepoint [1]
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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
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Secondary outcome [1]
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Change in 6-Minute Walk Distance From Baseline
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Assessment method [1]
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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.
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Timepoint [1]
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Baseline to Week 48
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Secondary outcome [2]
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Change in Borg Dyspnea Score From Baseline to Week 48
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Assessment method [2]
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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).
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Timepoint [2]
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Baseline to Week 48
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Secondary outcome [3]
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Change From Baseline to Week 48 in WHO Functional Class
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Assessment method [3]
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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.
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Timepoint [3]
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Baseline to Week 48
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Secondary outcome [4]
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Change in N-terminal Pro-brain Natriuretic Peptide (NT-proBNP) From Baseline to Week 48
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Assessment method [4]
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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)
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Timepoint [4]
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Baseline to Week 48
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Eligibility
Key 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.
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Minimum age
18
Years
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Maximum age
75
Years
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key 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.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
N/A
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Single group
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
11/09/2013
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
12/08/2021
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Sample size
Target
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Accrual to date
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Final
471
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Recruitment in Australia
Recruitment state(s)
NSW,QLD,TAS,VIC
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Recruitment hospital [1]
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Royal Prince Alfred Hospital - Camperdown
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Nepean Hospital - Kingswood
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Saint Vincents Hospital - Sydney
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Macquarie University - Sydney
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Royal Hobart Hospital - Hobart
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Royal Melbourne Hospital - Parkville
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2050 - Camperdown
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2751 - Kingswood
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2010 - Sydney
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2109 - Sydney
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4032 - Chermside
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7000 - Hobart
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3004 - Melbourne
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3050 - Parkville
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
United Therapeutics
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Ethics approval
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Summary
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.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT01560637
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Public notes
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Contacts
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT01560637
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