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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/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
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
Secondary ID [1] 0 0
TDE-PH-311
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Pulmonary Arterial Hypertension 0 0
Condition category
Condition code
Respiratory 0 0 0 0
Other respiratory disorders / diseases
Human Genetics and Inherited Disorders 0 0 0 0
Other human genetics and inherited disorders
Cardiovascular 0 0 0 0
Hypertension

Intervention/exposure
Study type
Interventional
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
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Number of Adverse Events
Timepoint [1] 0 0
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
Secondary outcome [1] 0 0
Change in 6-Minute Walk Distance From Baseline
Timepoint [1] 0 0
Baseline to Week 48
Secondary outcome [2] 0 0
Change in Borg Dyspnea Score From Baseline to Week 48
Timepoint [2] 0 0
Baseline to Week 48
Secondary outcome [3] 0 0
Change From Baseline to Week 48 in WHO Functional Class
Timepoint [3] 0 0
Baseline to Week 48
Secondary outcome [4] 0 0
Change in N-terminal Pro-brain Natriuretic Peptide (NT-proBNP) From Baseline to Week 48
Timepoint [4] 0 0
Baseline to Week 48

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.
Minimum age
18 Years
Maximum age
75 Years
Sex
Both males and females
Can healthy volunteers participate?
No
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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Not applicable
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
11/09/2013
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
12/08/2021
Sample size
Target
Accrual to date
Final
471
Recruitment in Australia
Recruitment state(s)
NSW,QLD,TAS,VIC
Recruitment hospital [1] 0 0
Royal Prince Alfred Hospital - Camperdown
Recruitment hospital [2] 0 0
Nepean Hospital - Kingswood
Recruitment hospital [3] 0 0
Saint Vincents Hospital - Sydney
Recruitment hospital [4] 0 0
Macquarie University - Sydney
Recruitment hospital [5] 0 0
Prince Charles Hospital - Chermside
Recruitment hospital [6] 0 0
Royal Hobart Hospital - Hobart
Recruitment hospital [7] 0 0
The Alfred Hospital - Melbourne
Recruitment hospital [8] 0 0
Royal Melbourne Hospital - Parkville
Recruitment postcode(s) [1] 0 0
2050 - Camperdown
Recruitment postcode(s) [2] 0 0
2751 - Kingswood
Recruitment postcode(s) [3] 0 0
2010 - Sydney
Recruitment postcode(s) [4] 0 0
2109 - Sydney
Recruitment postcode(s) [5] 0 0
4032 - Chermside
Recruitment postcode(s) [6] 0 0
7000 - Hobart
Recruitment postcode(s) [7] 0 0
3004 - Melbourne
Recruitment postcode(s) [8] 0 0
3050 - Parkville
Recruitment outside Australia
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United States of America
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Arizona
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North Carolina
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Virginia
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Napoli
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Bialystok
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Krakow
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Singapore
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Stockholm
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Taichung
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Taipei
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United Kingdom
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Cambridgshire
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United Kingdom
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England

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
United Therapeutics
Address
Country

Ethics approval
Ethics application status

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.
Trial website
https://clinicaltrials.gov/study/NCT01560637
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT01560637