Compassionate Use of Beraprost Sodium 314d Modified Release for Patients With Pulmonary Arterial Hypertension (PAH)
Status:
Completed
Trial end date:
2019-06-02
Target enrollment:
Participant gender:
Summary
The purpose of this study is to see if Lung LLC's new experimental formulation of the
medicine Beraprost Sodium, called Beraprost Sodium 314d Modified Release (BPS-314d-MR), can
improve the symptoms of pulmonary arterial hypertension (PAH) in patients. An experimental
drug is one that has not been approved by the U.S. Food and Drug Administration for use in
the general public. This research study is for patients who have pulmonary arterial
hypertension (PAH) and have just completed taking part in an earlier research study and
received an older experimental formulation of Beraprost Sodium, called Beraprost Sodium
Modified Release (BPS-MR). That earlier study was being done to see if BPS-MR could improve
their PAH.
Patients may also be taking Tyvaso (treprostinil), Tracleer (bosentan), Letairis
(ambrisentan), Adcirca (tadalafil) and/or Viagra or Revatio (sildenafil) to treat their PAH.
The diagnosis of PAH means that the blood pressure in their lungs is higher than normal. The
increased blood pressure in the lungs places a strain on the heart. The strain causes the
heart to pump less blood into the lungs, causing shortness of breath and tiredness. The
strain on the heart weakens the heart muscle making it less able to pump blood, a condition
called heart failure. As heart failure develops, swelling in the feet and abdomen may occur.
Phase:
Phase 2
Details
Lead Sponsor:
Los Angeles Biomedical Research Institute Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center