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

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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.

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.

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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Minneapolis, Minnesota 55455
(612) 625-5000
Univ of Minnesota With a flagship campus in the heart of the Twin Cities, and...
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1648 Pierce Dr NE
Atlanta, Georgia 30322
(404) 727-5640
Emory University School of Medicine Emory University School of Medicine has 2,359 full- and part-time...
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1720 2nd Ave S
Birmingham, Alabama 35233
(205) 934-4011 
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800 Washington St
Boston, Massachusetts 02111
(617) 636-5000
Tufts Medical Center Tufts Medical Center is an internationally-respected academic medical center – a teaching...
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5801 South Ellis Avenue
Chicago, Illinois 60637
 773.702.1234
University of Chicago One of the world's premier academic and research institutions, the University of...
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3300 Gallows Road
Falls Church, Virginia 22042
(703) 776-4001
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
(713) 500-4472
University of Texas Health Science Center at Houston The University of Texas Health Science Center...
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1211 Medical Center Dr
Nashville, Tennessee 37232
(615) 322-5000
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22 Bramhall St
Portland, Maine 04102
(207) 662-0111
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3181 Southwest Sam Jackson Park Road
Portland, Oregon 97239
503 494-8311
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Sacramento, California 95814
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1000 W Carson St
Torrance, California 90502
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2950 Cleveland Clinic Blvd.
Weston, Florida 33331
866.293.7866
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Alexandria, Louisiana 71301
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Aurora, Colorado 80045
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655 West Baltimore Street
Baltimore, Maryland 21201
(410) 706-7410
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Chapel Hill, North Carolina 27599
(919) 962-2211
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Chermside West, 4032
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Cincinnati, Ohio 45219
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2600 Clifton Ave
Cincinnati, Ohio 45267
(513) 556-6000
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11100 Euclid Ave
Cleveland, Ohio 44106
(216) 844-1000
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2049 E 100th St
Cleveland, Ohio 44106
(216) 444-2200
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281 W. Lane Ave
Columbus, Ohio 43210
(614) 292-6446
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Dallas, Texas 75390
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2301 Erwin Rd
Durham, North Carolina 27710
919-684-8111
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Iowa City, Iowa 52242
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Jacksonville, Florida 32209
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Los Angeles, California 90073
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Louisville, Kentucky 40202
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Milwaukee, Wisconsin 53215
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259 1st St
Mineola, New York 11501
(516) 663-0333
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5121 S Cottonwood St
Murray, Utah 84157
(801) 507-7000
Intermountain Medical Center Intermountain Medical Center is one of the most technologically advanced and patient-friendly...
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722 W 168th St
New York, New York 10032
(212) 305-2500
Columbia Presbyterian Med Ctr On January 1, 1998, The New York Hospital publicly announced its...
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201 Lyons Ave
Newark, New Jersey 07112
(973) 926-7000
Newark Beth Israel Medical Center Newark Beth Israel Medical Center, a regional care, teaching hospital...
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4242 Dewey Ave
Omaha, Nebraska 68105
(800) 922-0000
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3451 Walnut St
Philadelphia, Pennsylvania 19104
1 (215) 898-5000
Univ of Pennsylvania Penn has a long and proud tradition of intellectual rigor and pursuit...
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Phoenix, Arizona 85012
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Phoenix, Arizona 85054
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Pittsburgh, Pennsylvania 15260
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320 E North Ave
Pittsburgh, Pennsylvania 15212
(412) 359-3131
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Portland, Oregon 97210
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Rochester, Minnesota 55905
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1 Barnes Jewish Hospital Plaza
Saint Louis, Missouri 63110
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34800 Bob Wilson Drive
San Diego, California 92103
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1959 NE Pacific St
Seattle, Washington 98195
(206) 598-3300
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2801 W. Bancroft
Toledo, Ohio 43606
419.530.4636
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