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

National Center for Research Resources (NCRR)

Status and phase: Completed; Phase 4

Conditions: Hypertension, Pulmonary

Treatments: Drug: epoprostenol

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT00004754

BCM-P1850

199/11678

Details and patient eligibility

About

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.

Full 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.

Sex: All

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

PROTOCOL ENTRY CRITERIA:

• Severe primary pulmonary hypertension
• Able to prepare and self-administer medication