Phase IV Study of Chronic Infusional Epoprostenol for Severe Primary Pulmonary Hypertension
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|ClinicalTrials.gov Identifier: NCT00004754|
Recruitment Status : Completed
First Posted : February 25, 2000
Last Update Posted : June 24, 2005
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.
|Condition or disease||Intervention/treatment||Phase|
|Hypertension, Pulmonary||Drug: epoprostenol||Phase 4|
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.
|Study Type :||Interventional (Clinical Trial)|
|Masking:||None (Open Label)|
|Study Start Date :||August 1993|
U.S. FDA Resources
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00004754
|Study Chair:||Adaani E. Frost||Baylor College of Medicine|