An Open-Label Extension Trial of UT-15C SR in Subjects With Pulmonary Arterial Hypertension
Status: | Active, not recruiting |
---|---|
Conditions: | High Blood Pressure (Hypertension) |
Therapuetic Areas: | Cardiology / Vascular Diseases |
Healthy: | No |
Age Range: | 12 - Any |
Updated: | 9/20/2018 |
Start Date: | May 2006 |
End Date: | December 2020 |
This study provides, or continues to provide, UT-15C SR (treprostinil diethanolamine) to
eligible patients with pulmonary arterial hypertension who have completed protocols
TDE-PH-202, TDE-PH-203, TDE-PH-205, TDE-PH-301, TDE-PH-302, TDE-PH-308 studies or any
additional UT-15C SR clinical protocols evaluating subjects with PAH. The study assesses the
long term safety of UT-15C and the effect of continued treatment with UT-15C on exercise
capacity after one year of treatment.
eligible patients with pulmonary arterial hypertension who have completed protocols
TDE-PH-202, TDE-PH-203, TDE-PH-205, TDE-PH-301, TDE-PH-302, TDE-PH-308 studies or any
additional UT-15C SR clinical protocols evaluating subjects with PAH. The study assesses the
long term safety of UT-15C and the effect of continued treatment with UT-15C on exercise
capacity after one year of treatment.
This is an open-label study. Each subject's visit schedule will allow assessments after
defined periods of exposure to UT-15C SR (3, 6, 12, 24 and 36 months total exposure). The
study will continue with yearly visits beyond 36 months until either UT-15C SR is approved by
the appropriate regulatory authorities or the study is discontinued by the sponsor.
Therefore, the actual date of each visit will be determined by the date on which the subject
first received UT-15C SR (e.g., the date of study drug initiation in TDE-PH- 301, TDE-PH-302,
or TDE-PH-308 for subjects who were randomized to active therapy in those trials,and the date
of UT-15C SR initiation in this study for subjects who were randomized to placebo in the
previous controlled trial). Note that the TDE-PH-202, TDE-PH-203, TDE-PH-205 studies are
open-label design and therefore will follow the regimen for subjects receiving UT-15C SR.
defined periods of exposure to UT-15C SR (3, 6, 12, 24 and 36 months total exposure). The
study will continue with yearly visits beyond 36 months until either UT-15C SR is approved by
the appropriate regulatory authorities or the study is discontinued by the sponsor.
Therefore, the actual date of each visit will be determined by the date on which the subject
first received UT-15C SR (e.g., the date of study drug initiation in TDE-PH- 301, TDE-PH-302,
or TDE-PH-308 for subjects who were randomized to active therapy in those trials,and the date
of UT-15C SR initiation in this study for subjects who were randomized to placebo in the
previous controlled trial). Note that the TDE-PH-202, TDE-PH-203, TDE-PH-205 studies are
open-label design and therefore will follow the regimen for subjects receiving UT-15C SR.
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.
We found this trial at
51
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Inova Fairfax Hospital Inova Fairfax Hospital, Inova's flagship hospital, is an 833-bed, nationally recognized regional...
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7000 Fannin St
Houston, Texas 77030
Houston, Texas 77030
(713) 500-4472
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Univ of Minnesota With a flagship campus in the heart of the Twin Cities, and...
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1211 Medical Center Dr
Nashville, Tennessee 37232
Nashville, Tennessee 37232
(615) 322-5000
Vanderbilt Univ Med Ctr Vanderbilt University Medical Center (VUMC) is a comprehensive healthcare facility dedicated...
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3181 Southwest Sam Jackson Park Road
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Portland, Oregon 97239
503 494-8311
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Cleveland Clinic Florida Cleveland Clinic Florida, located in Weston, West Palm Beach, Palm Beach Gardens...
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655 West Baltimore Street
Baltimore, Maryland 21201
Baltimore, Maryland 21201
(410) 706-7410
University of Maryland School of Medicine Established in 1807, The School of Medicine is the...
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Univ of North Carolina Carolina’s vibrant people and programs attest to the University’s long-standing place...
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University of Cincinnati The University of Cincinnati offers students a balance of educational excellence and...
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Cleveland Clinic Foundation The Cleveland Clinic (formally known as The Cleveland Clinic Foundation) is a...
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Ohio State University The Ohio State University’s main Columbus campus is one of America’s largest...
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Duke Univ Med Ctr As a world-class academic and health care system, Duke Medicine strives...
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Winthrop University Hospital Founded in 1896 by a group of local physicians and concerned citizens,...
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Intermountain Medical Center Intermountain Medical Center is one of the most technologically advanced and patient-friendly...
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Columbia Presbyterian Med Ctr On January 1, 1998, The New York Hospital publicly announced its...
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Newark Beth Israel Medical Center Newark Beth Israel Medical Center, a regional care, teaching hospital...
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Nebraska Medical Center Formed in 1997 by combining the operations of University Hospital, Bishop Clarkson...
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Univ of Pennsylvania Penn has a long and proud tradition of intellectual rigor and pursuit...
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Allegheny General Hospital At Allegheny General Hospital, our physicians and healthcare staff have earned an...
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University of Washington Medical Center University of Washington Medical Center is one of the nation's...
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