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
Study type: Interventional
Phase: Phase 4

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).
    

Detailed description: 
      This is a multicentre, open label, single-arm study in approximately 20 adult patients (18 -
      75 years old) designed to evaluate the Impact on lifestyle of a new thermo stable formulation
      of epoprostenol sodium in subjects with Pulmonary Arterial Hypertension (PAH). The co-primary
      objectives are 1) to describe the effect of the new thermo stable formulation of epoprostenol
      sodium on quality of life and 2) to determine the dose titration requirement in patients
      switching from the currently marketed FLOLAN (epoprostenol sodium) to the new thermo stable
      formulation. Secondary objectives include assessing the safety, tolerability and efficacy of
      the thermo stable formulation of epoprostenol sodium and the exploratory objective is to
      evaluate the effect of the new thermo stable formulation of epoprostenol sodium on
      haemodynamic parameters in a subset of subjects.

      Subjects who are already receiving FLOLAN (epoprostenol sodium) for the treatment of PAH and
      have been on a stable dose for at least 3 months and on stable doses of other PAH treatments
      for at least 30 days prior to screening will be enrolled. After a screening visit, eligible
      subjects will have a 4-week run-in period with their existing FLOLAN (epoprostenol sodium)
      treatment. At the end of the 4-week period, they will be admitted to the clinic for baseline
      assessments and for switching to study medication (the new thermo stable formulation of
      epoprostenol sodium). Subjects will remain in hospital for a minimum of 6 hours to ensure
      clinical and hemodynamic stability prior to discharge. Subjects may stay in hospital for up
      to 24-48 hours after switching to the new thermo stable formulation of epoprostenol sodium at
      the discretion of the investigator. Dose titration requirement will be assessed at the time
      of discharge. Haemodynamic parameters will be obtained in a subgroup of subjects enrolled in
      centres where the collection of haemodynamic data is considered part of the standard of care.
      Subjects will receive the study medication as a continuous intravenous infusion for a 4-week
      treatment period. Those who complete the 4-week treatment period will have the option of
      entering an extension phase of the study to continue receiving the new formulation.
    

Intervention name(s): current marketed FLOLAN (epoprostenol sodium); new thermo stable formulation of epoprostenol sodium
Intervention type(s): Drug; Drug
Intervention description(s): continuous intravenous infusion; continuous intravenous infusion
Intervention MeSH terms: Epoprostenol; Tezosentan
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: flolan; pulmonary arterial hypertension; thermo stable formulation; epoprostenol sodium; modified sterile diluent