Oral Treprostinil in Subjects With Pulmonary Hypertension Associated With Heart Failure With Preserved Ejection Fraction
Status:
Terminated
Trial end date:
2019-12-03
Target enrollment:
Participant gender:
Summary
This was a multicenter, randomized (1:1; oral treprostinil to placebo), double-blind,
placebo-controlled study in subjects with World Health Organization (WHO) Group 2 pulmonary
hypertension (PH) associated with heart failure with preserved ejection fraction (HFpEF).
Once randomized, subjects took the initial dose of study drug at the study site on the day of
randomization. Subjects returned to the study site for visits scheduled at Weeks 6, 12, 18,
and 24. The duration of study participation was approximately 28 weeks from Screening until
study completion (includes a 30-day Screening Phase and 24-week Treatment Phase).
The study was discontinued by the Sponsor on 14 October 2019 due to slow enrollment. As only
a small portion of the anticipated total subjects had been enrolled, with many terminating
early due to the study termination, there was a limited ability to explore the effect of oral
treprostinil in this indication in this study.