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

This study has been completed.
Sponsor:
Collaborator:
Baylor College of Medicine
Information provided by:
Office of Rare Diseases (ORD)
ClinicalTrials.gov Identifier:
NCT00004754
First received: February 24, 2000
Last updated: June 23, 2005
Last verified: December 2001
History of Changes
  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 4

Study Type: Interventional
Study Design: Masking: Open Label
Primary Purpose: Treatment

Resource links provided by NLM:

U.S. FDA Resources

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

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

Additional relevant MeSH terms:
Hypertension, Pulmonary
Hypertension
Lung Diseases
Respiratory Tract Diseases
Vascular Diseases
Cardiovascular Diseases
Epoprostenol
Tezosentan
 Platelet Aggregation Inhibitors
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions
Antihypertensive Agents
Cardiovascular Agents
Vasodilator Agents

ClinicalTrials.gov processed this record on June 17, 2013