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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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
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2950 Cleveland Clinic Blvd.
Weston, Florida 33331
866.293.7866
Principal Investigator: Jinesh Mehta, MD, MHS
Phone: 954-659-6213
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185 Cambridge Street
Boston, Massachusetts 02114
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800 Washington St
Boston, Massachusetts 02111
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Gainesville, Florida 32610
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Principal Investigator: Hassan Alnuaimat, M.D.
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7000 Fannin St
Houston, Texas 77030
(713) 500-4472
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Phone: 713-500-6851
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8700 Beverly Blvd # 8211
Los Angeles, California 90048
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3181 Southwest Sam Jackson Park Road
Portland, Oregon 97239
503 494-8311
Principal Investigator: Akram Khan, MD
Phone: 503-494-9443
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593 Eddy Street
Providence, Rhode Island 02903
401-444-4000
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60 Crittenden Blvd # 70
Rochester, New York 14642
(585) 275-2121
Principal Investigator: R. James White, M.D., Ph.D.
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Asheville, North Carolina 28802
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1364 Clifton Rd NE
Atlanta, Georgia 30322
(404) 712-2000
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Augusta, Georgia 30912
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12605 East 16th Avenue
Aurora, Colorado 80045
720-848-0000
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3820 Medical Park Drive Southwest
Austell, Georgia 30106
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Baltimore, Maryland 20742
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Caba, Buenos Aires
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Carmel, Indiana 46032
Principal Investigator: William Harvey, MD
Phone: 317-435-8066
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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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Cleveland, Ohio 44106
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281 W. Lane Ave
Columbus, Ohio 43210
(614) 292-6446
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Detroit, Michigan 48202
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Fresno, California
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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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653 8th Street West
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Jacksonville, Florida 32209
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Louisville, Kentucky 40202
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Milwaukee, Wisconsin 53215
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201 Lyons Ave
Newark, New Jersey 07112
(973) 926-7000
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Norfolk, Virginia 23507
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4242 Dewey Ave
Omaha, Nebraska 68105
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Richmond, Virginia 23298
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Troy, Michigan 48085
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Tucson, Arizona 85721
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