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Active Clinical Trials

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

NCT:
03043651
Allegheny General Hospital
Allegheny General Hospital

Sponsor: 
United Therapeutics
Contact: 

For more information, please contact Joan Rossi at 412-359-3293 or Joan.Rossi@ahn.org.

SOUTHPAW2, TDE-HF-302; 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

Purpose: 

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.

Ages Eligible for Study:  18 Years to 79 Years   (Adult, Senior)

Sexes Eligible for Study:  All

Accepts Healthy Volunteers:  No

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.