Pulmonary Arterial Hypertension Clinical Trial
Official title:
An Open-label Extension of BPS-314d-MR-PAH-302 in Pulmonary Arterial Hypertension Patients
This is a multi-center, open-label study for eligible participants who were actively participating in the BPS-314d-MR-PAH-302 double-blind study (NCT01908699) at the time the study was concluded. This open-label extension (OLE) study will evaluate the safety, tolerability, and efficacy of long-term treatment with esuberaprost sodium tablets (Beraprost Sodium 314d Modified Release tablets).
Participants will sign an informed consent to continue treatment for pulmonary arterial
hypertension (PAH) with esuberaprost sodium tablets in this OLE study. At the Enrollment
Visit for this OLE study, participants will begin a blinded transition from the
BPS-314d-MR-PAH-302 double-blind study to this study over 4 weeks. The first dose for all
participants in this OLE study will be 2 tablets. During this blinded transition, those
participants on active study drug in the BPS-314d-MR-PAH-302 study will continue with blinded
active study drug 4-times daily (QID); those participants who were on placebo study drug will
receive 1 active tablet and 1 placebo tablet QID (blinded) during the first 2 weeks and
increase to 2 active tablets QID (blinded) thereafter. After the first dose, the Investigator
may adjust the dose as medically warranted. The maximum dose for this study is 30 microgram
(μg) QID with a minimum accepted dose as 15 μg QID. For the first 4 weeks, contact with the
participant should occur weekly to ensure up-titration to the fixed dose is tolerated and
assess adverse events (AEs).
Participants will return to the clinic at Week 4 to be supplied open-label esuberaprost
sodium tablets and complete protocol specified procedures. At the Week 4 Visit, participants
will be dosed with two 15 μg tablets (30 μg total), administered orally QID (provided the
target dose is tolerated), or follow the Investigator's (or designee's) directions if
adjustment is needed. Following the Week 4 Visit, each participant will return to the clinic
at Months 3, 6, 9, and 12, and quarterly thereafter for assessments.
This study is expected to continue until the first of any of the following are reached: the
study drug is commercially available, the Sponsor discontinues the study, or the Sponsor
offers enrollment in another study (estimated to be up to 2 years). At the conclusion of the
study or if a participant discontinues the study prematurely, participants will return to the
clinic for an End-of-Study (EOS) Visit. Participants will be provided instructions about down
titration off esuberaprost sodium tablets by the Investigator.
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