Study of a New Thermo Stable Formulation of Epoprostenol Sodium to Treat Pulmonary Arterial Hypertension (PAH)
Condition: Hypertension, Pulmonary
MeSH terms: Pulmonary Arterial Hypertension; Hypertension, Pulmonary; Hypertension
Intervention: current marketed FLOLAN (epoprostenol sodium); new thermo stable formulation of epoprostenol sodium
Intervention description: continuous intravenous infusion; continuous intravenous infusion
Intervention MeSH terms: Epoprostenol; Tezosentan
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 16.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: flolan; pulmonary arterial hypertension; thermo stable formulation; epoprostenol sodium; modified sterile diluent

Summary:

      The purpose of this multicentre, open label, single-arm study in approximately 20 adult
      patients is to evaluate the Impact on lifestyle of a new thermo stable formulation of
      epoprostenol sodium in subjects with Pulmonary Arterial Hypertension (PAH).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Adult male or female at least 18 to 75 years at the time of screening.

          -  Subjects must have been on FLOLAN (epoprostenol sodium) therapy for pulmonary arterial
             hypertension (PAH) as approved in the product label.

          -  Subjects must be on stable doses of their existing FLOLAN (epoprostenol sodium)
             treatment for a minimum of 3 months prior to screening.

          -  Subjects must be on stable doses of any current PAH treatments other than FLOLAN
             (epoprostenol sodium) in the last 30 days.

          -  Subjects must walk a distance of at least 150 meters during six-minute walk distance
             test (6MWD). This test must be completed during the Screening Visit.

          -  A female subject is eligible to participate if she is of non-childbearing potential or
             of childbearing potential, has a negative pregnancy test at screen, and agrees to use
             one of the contraception methods listed in the protocol.

          -  Subjects must be competent to understand the information given in the Institutional
             Review Board (IRB) or Independent Ethics Committee (IEC) approved informed consent
             form and must sign the form prior to the initiation of any study procedures.

        Exclusion Criteria:

          -  Subjects who are given FLOLAN (epoprostenol sodium) for a condition or in a manner
             that is outside the approved indication.

          -  Subjects with congestive heart failure arising from severe left ventricular
             dysfunction.

          -  Subjects, with or without supplemental oxygen, who have a resting arterial oxygen
             saturation (SaO2) <90% as measured by pulse oximetry at screening.

          -  Subjects have been hospitalized as an emergency or visited the emergency room for a
             condition related to PAH or treatment for PAH in the last 3 months.

          -  The subject's clinical condition is such that they are not expected to remain
             clinically stable for the duration of the study.

          -  Female subjects who are pregnant or breastfeeding.

          -  Subjects who have demonstrated noncompliance with previous medical regimens.

          -  Subjects who have a history of abusing alcohol or illicit drugs within 1 year.

          -  Subjects with a diagnosis of active hepatitis (hepatitis B surface antibody and
             hepatitis C antibody).

          -  Subjects who have participated in a clinical study involving another investigational
             drug or device within four weeks before screening.

          -  Subjects who had history malignancies within the past 5 years, with the exception of
             basal cell carcinoma of the skin or in situ carcinoma of the cervix.

          -  Any concurrent condition that would affect the safety of the subject or in the opinion
             of the investigator it is not in the best interest of the patient to participate in
             the study.