Study of Oral Treprostinil in Subjects With Pulmonary Hypertension (PH) Associated With Heart Failure With Preserved Ejection Fraction (HFpEF)



Status:Recruiting
Conditions:High Blood Pressure (Hypertension), High Blood Pressure (Hypertension), Cardiology
Therapuetic Areas:Cardiology / Vascular Diseases
Healthy:No
Age Range:18 - 79
Updated:3/8/2019
Start Date:August 15, 2017
End Date:December 2021
Contact:David B Yehle, RPh
Email:dyehle@unither.com
Phone:919 485-8350

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Trial Summary
Trial Overview
Inclusion Criteria

An Open-label Extension Study of Oral Treprostinil in Subjects With Pulmonary Hypertension (PH) Associated With Heart Failure With Preserved Ejection Fraction (HFpEF) - A Long-term Follow-up to Study TDE-HF-301

This is an open-label study to evaluate the safety of continued therapy with oral
treprostinil in subjects who have completed Study TDE-HF-301. This study will provide
long-term, open-label data regarding the effect of continued long-term oral treprostinil
therapy for the treatment of pulmonary hypertension (PH) associated with heart failure with
preserved ejection fraction (HFpEF). Subject visits will occur at Baseline, Weeks 6, 12, 18,
24, and every 12 weeks thereafter until either oral treprostinil becomes commercially
available to treat PH associated with HFpEF or the study is discontinued by the Sponsor.


Inclusion Criteria:

- The subject participated in Study TDE-HF-301, remained on study drug, was compliant
with study procedures and assessments during Study TDE-HF-301, and completed through
Week 24 of that study.

Exclusion Criteria

- The subject is pregnant or lactating.

- The subject was prematurely discontinued from Study TDE-HF-301 for any reason.

- The subject developed a concurrent illness or condition during Study TDE HF 301,
which, in the opinion of the Investigator, would represent a risk to the subject's
overall health if they enrolled in this study.
We found this trial at
82
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VitaLink Research - Anderson
55 East Camperdown Way
Anderson, South Carolina 29621
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University of Alabama at Birmingham
1720 2nd Ave S
Birmingham, Alabama 35233
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Brigham and Women's Hosp
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Boston, Massachusetts 02115
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Tufts Medical Center
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Boston, Massachusetts 02111
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Montefiore Medical Center
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Cleveland Clinic
9500 Euclid Avenue
Cleveland, Ohio 44106
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Baylor University Medical Center
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University of Texas Health Science Center at Houston
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Univ of Minnesota
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Vanderbilt University Medical Center
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New York, New York 10029
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Central Florida Pulmonary Group, PA
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Albany Medical College
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AnMed Health Pulmonary and Sleep Medicine
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University of Colorado Denver
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Piedmont Physicians Georgia Lung
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Medical University of South Carolina
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University of California, Davis Medical Center
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