Open-label Extension of Oral Treprostinil in Subjects With PH Associated With HFpEF
Status:
Terminated
Trial end date:
2020-03-02
Target enrollment:
Participant gender:
Summary
This was an open-label study to evaluate the safety of continued therapy with oral
treprostinil in subjects who completed Study TDE-HF-301. This study provided 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 occurred at Baseline, Weeks 6, 12, 18, 24, and
every 12 weeks thereafter until either oral treprostinil was commercially available to treat
PH associated with HFpEF or the study was discontinued by the Sponsor.
The Sponsor terminated Studies TDE-HF-301 and TDE-HF-302 on 14 October 2019 due to slow
enrollment. Safety data from the final subject in Study TDE-HF-302 were recorded on 02 March
2020. Due to the lower than expected number of subjects enrolled, the planned secondary
efficacy-related endpoints were not analyzed.