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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
Sponsor:
Collaborator:
Baylor College of Medicine
Information provided by:
Office of Rare Diseases (ORD)

February 24, 2000
February 25, 2000
June 24, 2005
August 1993
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No Changes Posted
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Phase IV Study of Chronic Infusional Epoprostenol for Severe Primary Pulmonary Hypertension
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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.

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.

Interventional
Phase 4
Masking: None (Open Label)
Primary Purpose: Treatment
Hypertension, Pulmonary
Drug: epoprostenol
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
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PROTOCOL ENTRY CRITERIA:

  • Severe primary pulmonary hypertension
  • Able to prepare and self-administer medication
Sexes Eligible for Study: All
Child, Adult, Older Adult
No
Contact information is only displayed when the study is recruiting subjects
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NCT00004754
199/11678
BCM-P1850
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National Center for Research Resources (NCRR)
Baylor College of Medicine
Study Chair: Adaani E. Frost Baylor College of Medicine
Office of Rare Diseases (ORD)
December 2001

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP