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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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12 December 2020 |
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Main ID: |
NCT01027949 |
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Date of registration:
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04/12/2009 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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An Open-Label Extension Trial of UT-15C SR in Subjects With Pulmonary Arterial Hypertension
FREEDOM-EXT |
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Scientific title:
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An Open-Label Extension Trial of UT-15C SR in Subjects With Pulmonary Arterial Hypertension |
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Date of first enrolment:
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May 2006 |
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Target sample size:
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900 |
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Recruitment status: |
Active, not recruiting |
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URL:
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https://clinicaltrials.gov/show/NCT01027949 |
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Study type:
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Interventional |
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Study design:
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Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
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Phase:
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Phase 3
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Countries of recruitment
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Australia
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Austria
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Belgium
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Canada
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Czech Republic
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France
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Germany
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India
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Ireland
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Israel
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Italy
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Mexico
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Netherlands
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Poland
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Portugal
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Puerto Rico
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Spain
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Sweden
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United Kingdom
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United States
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Contacts
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Name:
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Jeff Sigman |
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Address:
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Telephone:
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Email:
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Affiliation:
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United Therapeutics |
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Key inclusion & exclusion criteria
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Participation in study TDE-PH-202, TDE-PH-203, TDE-PH-205, TDE-PH-301,
TDE-PH-302,TDE-PH-308 or any additional UT-15C SR clinical protocol is required. Subjects
must complete all assessments in one of these studies to be eligible.
Age minimum:
12 Years
Age maximum:
N/A
Gender:
All
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Health Condition(s) or Problem(s) studied
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Pulmonary Arterial Hypertension
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Intervention(s)
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Drug: Treprostinil diethanolamine
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Primary Outcome(s)
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Continued therapy effect on exercise capacity as assessed by a 6-Minute Walk Test
[Time Frame: Once, after one year of therapy with UT-15C SR.]
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Long-term safety as assessed by adverse events
[Time Frame: Performed monthly during monthly telephone calls]
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Long-term safety as assessed by clinical laboratories
[Time Frame: Performed at each study scheduled visit]
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Secondary ID(s)
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TDE-PH-304
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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