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



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

For Condition: Hypertension, Pulmonary
Status: Completed
Sponsor(s): National Center for Research Resources (NCRR) , Baylor College of Medicine
Synopsis: 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.
Details: 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:
Study Type:
  Interventional, Treatment, Open Label
Minimum Age/Maximum Age: /
Genders: Both
Protocol Entry Criteria: PROTOCOL ENTRY CRITERIA: - Severe primary pulmonary hypertension - Able to prepare and self-administer medication
Total Enrollment: 

Location and Contact Information:

Overall Study Official:
AdaaniFrost,  Study Chair,  Baylor College of Medicine


Additional Information:
Study ID Numbers:
  199/11678;  BCM-P1850
Study Start Date: August 1993
Record last reviewed: December 2001
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00004754

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