NCT00004754

Phase IV Study of Chronic Infusional Epoprostenol for Severe Primary Pulmonary Hypertension

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: —
• Sponsor: National Center for Research Resources (NCRR) · NIH
• Sex: All
• Age: 0 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Hypertension, Pulmonary

Interventions

Type	Name	Description
DRUG	epoprostenol

Timeline

• Start date: 1993-08-01
• First posted: 2000-02-25
• Last updated: 2005-06-24