A Study With BPS-314d-MR-PAH-303 in Participants With Pulmonary Arterial Hypertension
Condition: Pulmonary Arterial Hypertension
MeSH terms: Pulmonary Arterial Hypertension; Familial Primary Pulmonary Hypertension; Hypertension
Intervention: Esuberaprost; Placebo
Intervention description: Sodium tablets; Placebo tablets, which are identical in size and appearance to those containing Esuberaprost.
Intervention MeSH terms: Beraprost
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Masking description: Treatment during the first 4 weeks of this study will be double-blind. The Investigator and study staff, the participants, the monitors, and the Sponsor will remain blinded to the treatment group allocation from BPS-314d-MR-PAH-302 double-blind study (NCT01908699) and to study drug during the first 4 weeks of the OLE study while the participants transition to the OLE treatment. After the 4 weeks, the study will continue as unblinded and open label.
Enrollment: 112.0
Sex: All
Minimum age: 18 Years
Maximum age: 85 Years
Healthy volunteers: No
Keywords: Hypertension; Familial Primary Pulmonary Hypertension; Hypertension, Pulmonary; Lung Diseases; Vascular Diseases; Cardiovascular Diseases; Respiratory Tract Diseases; Prostacyclin; Beraprost; Epoprostenol; Platelet Aggregation Inhibitors; Vasodilator Agents; Antihypertensive Agents

Summary:

      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).
    

Eligibility criteria:

        Inclusion Criteria:

          1. Participant must have been actively participating in the double-blind study,
             BPS-314d-MR-PAH-302 (NCT01908699), when the Sponsor concluded that study.

          2. In the Investigator's opinion, participant must be competent to understand the
             information given in the Institutional Review Board (IRB) or Independent Ethics
             Committee (IEC) approved informed consent form (ICF) and must sign the form prior to
             the initiation of any study procedures.

          3. Women of child-bearing potential (defined as less than 1 year post-menopausal and not
             surgically sterile) must be practicing abstinence or using 2 highly-effective methods
             of contraception (defined as a method of birth control that results in a low failure
             rate [that is, less than 1% per year, such as approved hormonal contraceptives,
             barrier methods (such as a condom or diaphragm) used with a spermicide or an
             intrauterine device]). Participant must have a negative pregnancy test at the
             BPS-314d-MR-PAH-302 EOS Visit / BPS-314d-MR-PAH-303 Enrollment Visit.

          4. Participant must be willing and able to comply with study requirements and
             restrictions.

        Exclusion Criteria:

          1. Participant is pregnant or lactating.

          2. Participant is scheduled to receive another investigational drug, device, or therapy
             during the course of the study.

          3. Participant is taking or intends to take any prostacyclin / prostacyclin (IP) analog
             or IP receptor agonist (except for treprostinil, inhaled [Tyvaso®]).

          4. Participant has any other clinically significant illness or other reason that, in the
             opinion of the Investigator, might put the participant at risk of harm during the
             study or might adversely affect the interpretation of the study data.