Phase IV Study of Chronic Infusional Epoprostenol for Severe Primary Pulmonary Hypertension
OBJECTIVES: I. Provide epoprostenol (Flolan, prostaglandin I2) by chronic infusion to patients with severe primary pulmonary hypertension for whom no alternative therapy is available.
II. Obtain additional safety information on continuous infusion epoprostenol. III. Obtain additional information on economic resource health consumption.
|Study Design:||Masking: Open Label
Primary Purpose: Treatment
|Study Start Date:||August 1993|
PROTOCOL OUTLINE: Patients are treated with a chronic continuous infusion of epoprostenol.
The highest tolerated infusion rate is determined for each patient by gradually increasing the rate until the target dose is reached or the patient experiences at least 1 dose-limiting effect.
Patients are subsequently treated with a chronic continuous infusion, beginning at a rate below the highest tolerated rate. Attempts are made to increase the dose to the highest tolerated rate over the first 72 hours.
|Study Chair:||Adaani E. Frost||Baylor College of Medicine|