Long-term Safety and Efficacy of Ralinepag in Pulmonary Arterial Hypertension
Condition: Pulmonary Arterial Hypertension
MeSH terms: Pulmonary Arterial Hypertension; Familial Primary Pulmonary Hypertension; Hypertension
Intervention: Ralinepag
Intervention description: Active
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 45.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No

Summary:

      This study was an open-label extension study to determine the long-term safety and
      tolerability of ralinepag in subjects with World Health Organization (WHO) Group 1 pulmonary
      arterial hypertension (PAH) who have completed Study APD811-003, or who were assigned to
      receive placebo and were discontinued due to clinical worsening.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Evidence of a personally signed and dated informed consent document.

          -  Was willing and able to comply with scheduled visits, treatment plan, laboratory
             tests, and other study procedures and was deemed an appropriate candidate for
             participation in a long-term extension study.

          -  Female subjects were nonpregnant, nonlactating, surgically sterile or postmenopausal,
             or agreed to use an accepted method of birth control for at least 3 months prior to
             the first dose, during, and for at least 30 days after the last dose of study drug.

          -  Male subjects were either surgically sterile or agreed to use a condom with spermicide
             when sexually active with a female partner who was not using an acceptable method of
             birth control during the study and for 30 days after the last dose of study drug.

          -  Male and female subjects agreed not to participate in a conception process during the
             study and for 30 days after the last dose of study drug.

          -  Fulfilled all eligibility criteria for Study APD811-003 and completed the study as
             planned.

        Subjects who were assigned to placebo in Study APD811-003 and experienced clinical
        worsening in that study could enroll in Study APD811-007 after completing all end of study
        procedures per protocol, including RHC, for Study APD811-003 and had their data locked.

        Exclusion Criteria:

          -  Subjects who enrolled in Study APD811-003 and were withdrawn from study drug treatment
             due to any adverse event (AE), serious adverse event (SAE), or subjects who did not
             complete Study APD811003, with the exception made for placebo-treated subjects who
             experienced a clinical worsening event.

          -  Female •subjects who wished to become pregnant.

          -  Systolic blood pressure <90 mmHg at Baseline.

          -  Other severe acute or chronic medical or laboratory abnormalities that could have
             increased the risk associated with study participation or investigational product
             administration or interfered with the interpretation of study results and, in the
             judgment of the investigator, would have made the subject inappropriate for entry into
             this study.