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

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

  • Pulmonary Hypertension Associated With HFpEF

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

Banner University Medical Center Phoenix
Phoenix, Arizona 85006
Contact:
Monya Pierce
602-828-2431
Monya.Pierce@bannerhealth.com

More Details

NCT ID
NCT03043651
Status
Recruiting
Sponsor
United Therapeutics

Study Contact

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