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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

Page last updated: August 23, 2015

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