Study of Oral Treprostinil in Subjects With Pulmonary Hypertension (PH) Associated With Heart Failure With Preserved Ejection Fraction (HFpEF)
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.
- Pulmonary Hypertension Associated With HFpEF
- Eligible Ages
- Between 18 Years and 79 Years
- Eligible Genders
- Accepts Healthy Volunteers
- 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.
- 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.
- Phase 3
- Study Type
- Intervention Model
- Single Group Assignment
- Primary Purpose
- None (Open Label)
|Sustained-Release tablets for three times daily (TID) administration||
- NCT ID
- United Therapeutics
Study ContactDavid B Yehle, RPh