Trial of the Early Combination of Oral Treprostinil With Background Oral Monotherapy in Subjects With Pulmonary Arterial Hypertension



Status:Completed
Conditions:High Blood Pressure (Hypertension)
Therapuetic Areas:Cardiology / Vascular Diseases
Healthy:No
Age Range:18 - 75
Updated:7/19/2018
Start Date:July 2012
End Date:June 24, 2018

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Trial Summary
Trial Overview
Inclusion Criteria

A Phase III, International, Multi-Center, Randomized, Double- Blind, Placebo-Controlled, Clinical Worsening Study of UT-15C in Subjects With Pulmonary Arterial Hypertension Receiving Background Oral Monotherapy

This study is an international, multicenter, randomized (1:1 oral treprostinil (UT-15C):
placebo), double-blind, placebo-controlled study in subjects with Pulmonary Arterial
Hypertension (PAH) who are currently receiving background oral monotherapy for at least 30
days at randomization for their PAH. Study visits will occur in four week intervals for the
first 12 weeks, then every 12 weeks thereafter with key measures of efficacy being time to
first clinical worsening event and the 6-minute walk test at Week 24. Study procedures
include routine blood tests, medical history, physical exams, disease evaluation, and
exercise tests. Patients who complete all required assessments will also be eligible to enter
a long-term, open-label, extension study (TDE-PH-311).


Inclusion Criteria:

1. Between 18 and 75 years of age, inclusive

2. PAH that is idiopathic / heritable, PAH associated with connective tissue disease, HIV
infection, repaired congenital systemic-to-pulmonary shunts (repaired > 1 year), or
appetite suppressant / toxin use

3. Receiving one PAH-approved oral therapy at an appropriate dose

4. Previous testing (e.g. right heart catheterization, echocardiography) consistent with
diagnosis of PAH

Exclusion Criteria:

1. Nursing or pregnant

2. PAH due to conditions other than noted in the above inclusion criteria

3. History of uncontrolled sleep apnea, severe liver disease, left sided heart disease,
uncontrolled systemic hypertension

4. Use of an investigational drug or device within 30 days of Screening
We found this trial at
40
sites
Virginia Commonwealth University
Richmond, Virginia 23298
(804) 828-0100
Principal Investigator: Daniel Grinnan, M.D.
Virginia Commonwealth University Since our founding as a medical school in 1838, Virginia Commonwealth University...
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Massachusetts General Hospital
185 Cambridge Street
Boston, Massachusetts 02114
617-724-5200
Principal Investigator: Aaron Waxman, MD, PhD
Phone: 617-525-9731
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Tufts Medical Center
800 Washington St
Boston, Massachusetts 02111
(617) 636-5000
Principal Investigator: Nicholas Hill, MD
Phone: 617-636-1334
Tufts Medical Center Tufts Medical Center is an internationally-respected academic medical center – a teaching...
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University of Florida
Gainesville, Florida 32610
(352) 392-3261
Principal Investigator: Hassan Alnuaimat, M.D.
Phone: 352-273-8990
University of Florida The University of Florida (UF) is a major, public, comprehensive, land-grant, research...
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University of Texas Health Science Center at Houston
7000 Fannin St
Houston, Texas 77030
(713) 500-4472
Principal Investigator: Bela Patel, M.D.
Phone: 713-500-6851
University of Texas Health Science Center at Houston The University of Texas Health Science Center...
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Cedars-Sinai Medical Center
8700 Beverly Blvd # 8211
Los Angeles, California 90048
(1-800-233-2771)
Principal Investigator: Antoine Hage, MD
Phone: 310-248-7134
Cedars Sinai Med Ctr Cedars-Sinai is known for providing the highest quality patient care. Our...
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Oregon Health and Science University
3181 Southwest Sam Jackson Park Road
Portland, Oregon 97239
503 494-8311
Principal Investigator: Akram Khan, MD
Phone: 503-494-9443
Oregon Health and Science University In 1887, the inaugural class of the University of Oregon...
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Rhode Island Hospital
593 Eddy Street
Providence, Rhode Island 02903
401-444-4000
Principal Investigator: James Klinger, M.D.
Phone: 401-444-9097
Rhode Island Hospital Founded in 1863, Rhode Island Hospital in Providence, RI, is a private,...
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University of Rochester
60 Crittenden Blvd # 70
Rochester, New York 14642
(585) 275-2121
Principal Investigator: R. James White, M.D., Ph.D.
Phone: 585-486-0869
University of Rochester The University of Rochester is one of the country's top-tier research universities....
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Cleveland Clinic Florida
2950 Cleveland Clinic Blvd.
Weston, Florida 33331
866.293.7866
Principal Investigator: Jinesh Mehta, MD, MHS
Phone: 954-659-6213
Cleveland Clinic Florida Cleveland Clinic Florida, located in Weston, West Palm Beach, Palm Beach Gardens...
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Asheville Cardiology Associates
Asheville, North Carolina 28802
Principal Investigator: Benjamin Trichon, MD
Phone: 828-274-6000
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Emory University Hospital
1364 Clifton Rd NE
Atlanta, Georgia 30322
(404) 712-2000
Principal Investigator: Micah Fisher, MD
Phone: 404-712-7458
Emory University Hospital As the largest health care system in Georgia and the only health...
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Augusta University
Augusta, Georgia 30912
Principal Investigator: Clark McDonough, MD
Phone: 706-721-0193
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University of Colorado Hospital
12605 East 16th Avenue
Aurora, Colorado 80045
720-848-0000
Principal Investigator: David Badesch, M.D.
Phone: 720-848-2611
University of Colorado Hospital, Site Top medical professionals, superior medicine and progressive change make University...
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Piedmont - Georgia Lung Associates
3820 Medical Park Drive Southwest
Austell, Georgia 30106
Principal Investigator: Chad Miller
Phone: 770-745-1404
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University of Maryland
Baltimore, Maryland 20742
(301) 405-1000
University of Maryland As a globally-connected university offering a world-class education, the University of Maryland...
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Sanatorio San José
Caba, Buenos Aires
Principal Investigator: Adrian Lescano, MD
Phone: 541148222748
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Indiana University Hospital
Carmel, Indiana 46032
Principal Investigator: William Harvey, MD
Phone: 317-435-8066
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Carmel, IN
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University of Cincinnati
2600 Clifton Ave
Cincinnati, Ohio 45267
(513) 556-6000
Principal Investigator: Jean Elwing, M.D.
Phone: 513-558-2148
University of Cincinnati The University of Cincinnati offers students a balance of educational excellence and...
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University Hospital
Cleveland, Ohio 44106
Principal Investigator: Robert Schilz, DO, PhD
Phone: 216-844-2897
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Cleveland, OH
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Ohio State University
281 W. Lane Ave
Columbus, Ohio 43210
(614) 292-6446
Principal Investigator: Veronica Franco, M.D.
Phone: 614-366-4593
Ohio State University The Ohio State University’s main Columbus campus is one of America’s largest...
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Henry Ford Health System
Detroit, Michigan 48202
Principal Investigator: Rana Awdish, M.D.
Phone: 313-916-1254
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University of California San Francisco-Fresno
Fresno, California
Principal Investigator: Vijay Balasubramanian, M.D.
Phone: 559-499-6637
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University of Iowa Hospitals and Clinics
200 Hawkins Dr,
Iowa City, Iowa 52242
866-452-8507
Principal Investigator: Linda Cadaret, M.D.
Phone: 319-353-7953
University of Iowa Hospitals and Clinics University of Iowa Hospitals and Clinics—recognized as one of...
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University of Florida College of Medicine Jacksonville- Division of Pulmonary & Critical Medicine
653 8th Street West
Jacksonville, Florida 32209
Principal Investigator: Abubakr Bajwa
Phone: 904-244-1106
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University of Florida College of Medicine Jacksonville
Jacksonville, Florida 32209
Principal Investigator: Vandana Seeram, MD
Phone: 904-244-1106
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Kentuckiana Pulmonary Associates
Louisville, Kentucky 40202
Principal Investigator: John McConnell, M.D.
Phone: 502-587-8000
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Aurora Saint Lukes Medical Center
Milwaukee, Wisconsin 53215
Principal Investigator: Dianne Zwicke, MD
Phone: 414-649-5664
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Newark Beth Israel Medical Center
201 Lyons Ave
Newark, New Jersey 07112
(973) 926-7000
Principal Investigator: Christina Migliore, MD
Phone: 973-926-8135
Newark Beth Israel Medical Center Newark Beth Israel Medical Center, a regional care, teaching hospital...
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Sentara Cardiovascular Research Institute
Norfolk, Virginia 23507
Principal Investigator: Michael Eggert
Phone: 757-388-4024
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Nebraska Medical Center
4242 Dewey Ave
Omaha, Nebraska 68105
(800) 922-0000
Principal Investigator: Austin B Thompson, MD
Phone: 402-559-7585
Nebraska Medical Center Formed in 1997 by combining the operations of University Hospital, Bishop Clarkson...
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HeartCare Midwest
Peoria, Illinois 61614
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Perelman Center for Advanced Medicine at the University of Pennsylvania
Philadelphia, Pennsylvania 19104
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Arizona Pulmonary Specialists, Ltd.
Phoenix, Arizona 85013
Principal Investigator: Jeremy Feldman, M.D.
Phone: 602-271-0832
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University of Pittsburgh Medical Center - Presbyterian Cardiovascular Institute
Pittsburgh, Pennsylvania 15213
Principal Investigator: Michael Mathier, MD
Phone: 412-692-2769
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Legacy Research Institute
Portland, Oregon 97232
Principal Investigator: Catherine Markin, MD
Phone: 503-413-7945
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Portland, OR
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University of California-Davis Medical Group, Advanced Lung Disease/Transplant Program
Sacramento, California 95817
Principal Investigator: Roblee Allen, MD
Phone: 916-734-1554
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David Geffen School of Medicine
Torrance, California 90502
Principal Investigator: Ronald Oudiz, M.D.
Phone: 310-222-3560
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Beaumont Health
Troy, Michigan 48085
Principal Investigator: Samuel Allen, DO
Phone: 248-964-8524
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University of Arizona
Tucson, Arizona 85721
(520) 621-2211
University of Arizona The University of Arizona is a premier, public research university. Established in...
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