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.

Condition

Eligibility

Eligible Ages
Between 18 Years and 79 Years
Eligible Genders
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.

Study Design

Phase
Phase 3
Study Type
Interventional
Intervention Model
Single Group Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Oral treprostinil
Sustained-Release tablets for three times daily (TID) administration
  • Drug: Oral Treprostinil
    Sustained-release oral tablets for TID administration
    Other names:
    • Treprostinil diethanolamine

Recruiting Locations

Montefiore Medical Center
Bronx, New York 10461
Contact:
Johanna Oviedo
718-920-8780
joviedo@montefiore.org

More Details

NCT ID
NCT03043651
Status
Recruiting
Sponsor
United Therapeutics

Study Contact

David B Yehle, RPh
919 485-8350
dyehle@unither.com

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.