FREEDOM - M: Oral Treprostinil as Monotherapy for the Treatment of Pulmonary Arterial Hypertension (PAH)



Status:Archived
Conditions:High Blood Pressure (Hypertension)
Therapuetic Areas:Cardiology / Vascular Diseases
Healthy:No
Age Range:Any
Updated:7/1/2011

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A 12-Week, International, Multicenter, Double-Blind, Randomized, Placebo-Controlled Comparison of the Efficacy and Safety of Oral UT-15C Sustained Release Tablets in Subjects With Pulmonary Arterial Hypertension


This study is an international, multicenter, randomized (2:1 active:placebo), double-blind,
placebo-controlled study in subjects with PAH who are NOT currently receiving approved
therapy for their PAH. Study visits will occur at 4 week intervals for 12 weeks (with an
additional visit at week 11) with the key measure of efficacy being the 6-minute walk test.
Study procedures include routine blood tests, medical history, physical exams, disease
evaluation, and exercise tests. Two optional substudies are also a part of FREEDOM-M at
select centers - a hemodynamic substudy with a right heart catheterization at Baseline and
Week 12 and a genetics and biomarkers substudy with blood samples collected at Baseline and
Week 12.

Patients who complete all assessments for 12 weeks will also be eligible to enter a 36 month
open-label, extension phase study (FREEDOM - EXT).



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31
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Aurora, Colorado 80045
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1720 2nd Ave S
Birmingham, Alabama 35233
(205) 934-4011 
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234 Goodman Dr
Cincinnati, Ohio 45229
(513) 584-1000
University of Cincinnati Medical Center Opening in 1823 as the country
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5303 Harry Hines Boulevard
Dallas, Texas 75390
(214) 648-3111
UT Soutwestern Medical Center at Dallas UT Southwestern Medical Center is distinctive for its overall...
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101 Jessup Hall
Iowa City, Iowa 52242
(319) 335-3500
University of Iowa With just over 30,000 students, the University of Iowa is one of...
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22 Bramhall Street
Portland, Maine 04102
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3181 Southwest Sam Jackson Park Road
Portland, Oregon 97239
503 494-8311
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1 Brookings Drive
St. Louis, Missouri 63110
 (314) 935-5000
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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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Boston, Massachusetts 02111
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101 Manning Dr
Chapel Hill, North Carolina 27599
(919) 966-4131
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850 Boylston Street
Chestnut Hill, Massachusetts 02467
1-800-BWH-9999
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Cincinnati, Ohio 45219
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10900 Euclid Ave
Cleveland, Ohio 44106
216-368-2000
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281 W. Lane Ave
Columbus, Ohio 43210
(614) 292-6446
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1 Baylor Plaza
Houston, Texas 77030
(713) 798-4951
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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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201 Lyons Ave
Newark, New Jersey 07112
(973) 926-7000
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Phoenix, Arizona 85054
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Phoenix, Arizona 85012
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Pittsburgh, Pennsylvania 15212
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200 Lothrop St
Pittsburgh, Pennsylvania 15213
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Portland, Oregon 97210
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200 First Street SW
Rochester, Minnesota 55905
507-284-2511
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Sacramento, California 95817
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