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

This study has been completed.

First Received: February 24, 2000 Last Updated: June 23, 2005 History of Changes

Sponsors and Collaborators:	National Center for Research Resources (NCRR) Baylor College of Medicine
Information provided by:	Office of Rare Diseases (ORD)
ClinicalTrials.gov Identifier:	NCT00004754

Purpose

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	Intervention	Phase
Hypertension, Pulmonary	Drug: epoprostenol	Phase IV

Genetics Home Reference related topics: pulmonary arterial hypertension

MedlinePlus related topics: High Blood Pressure Pulmonary Hypertension

Drug Information available for: Epoprostenol Epoprostenol sodium

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Open Label

Further study details as provided by Office of Rare Diseases (ORD):

Study Start Date:

August 1993

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

Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

PROTOCOL ENTRY CRITERIA:

Severe primary pulmonary hypertension
Able to prepare and self-administer medication

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00004754

Sponsors and Collaborators

National Center for Research Resources (NCRR)

Baylor College of Medicine

Investigators

Study Chair:

Adaani E. Frost

Baylor College of Medicine

More Information

No publications provided

Study ID Numbers:	199/11678, BCM-P1850
Study First Received:	February 24, 2000
Last Updated:	June 23, 2005
ClinicalTrials.gov Identifier:	NCT00004754 History of Changes
Health Authority:	United States: Federal Government

Keywords provided by Office of Rare Diseases (ORD):

cardiovascular and respiratory diseases
hypertensive disorder
primary pulmonary hypertension
rare disease

Study placed in the following topic categories:

Respiratory Tract Diseases
Hypertension, Pulmonary
Lung Diseases
Respiration Disorders
Epoprostenol
Idiopathic Pulmonary Hypertension

Vascular Diseases
Rare Diseases
Platelet Aggregation Inhibitors
Cardiovascular Agents
Antihypertensive Agents
Hypertension

Additional relevant MeSH terms:

Hematologic Agents
Vascular Diseases
Cardiovascular Agents
Antihypertensive Agents
Pharmacologic Actions
Respiratory Tract Diseases
Hypertension, Pulmonary

Lung Diseases
Therapeutic Uses
Epoprostenol
Cardiovascular Diseases
Platelet Aggregation Inhibitors
Hypertension

ClinicalTrials.gov processed this record on May 07, 2009