Phase IV Study of Chronic Infusional Epoprostenol for Severe Primary Pulmonary Hypertension
Information source: Office of Rare Diseases (ORD)
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Hypertension, Pulmonary
Intervention: epoprostenol (Drug)
Phase: Phase 4
Status: Completed
Sponsored by: National Center for Research Resources (NCRR) Official(s) and/or principal investigator(s):
Adaani E. Frost, Study Chair, Affiliation: Baylor College of Medicine
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.
Clinical Details
Study design: Masking: Open Label, Primary Purpose: Treatment
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.
Eligibility
Minimum age: N/A.
Maximum age: N/A.
Gender(s): Both.
Criteria:
PROTOCOL ENTRY CRITERIA:
- Severe primary pulmonary hypertension
- Able to prepare and self-administer medication
Locations and Contacts
Additional Information
Starting date: August 1993
Last updated: June 23, 2005
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