Back to resultsPhase IV Study of Chronic Infusional Epoprostenol for Severe Primary Pulmonary Hypertension
Primary Purpose
Hypertension, Pulmonary
Status
Completed
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
epoprostenol
Sponsored by
About this trial
This is an interventional treatment trial for Hypertension, Pulmonary focused on measuring cardiovascular and respiratory diseases, hypertensive disorder, primary pulmonary hypertension, rare disease
Eligibility Criteria
PROTOCOL ENTRY CRITERIA: Severe primary pulmonary hypertension Able to prepare and self-administer medication
Sites / Locations
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
NCT ID
NCT00004754
First Posted
February 24, 2000
Last Updated
June 23, 2005
Sponsor
National Center for Research Resources (NCRR)
Collaborators
Baylor College of Medicine
1. Study Identification
Unique Protocol Identification Number
NCT00004754
Brief Title
Phase IV Study of Chronic Infusional Epoprostenol for Severe Primary Pulmonary Hypertension
Study Type
Interventional
2. Study Status
Record Verification Date
December 2001
Overall Recruitment Status
Completed
Study Start Date
August 1993 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
National Center for Research Resources (NCRR)
Collaborators
Baylor College of Medicine
4. Oversight
5. Study Description
Brief Summary
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypertension, Pulmonary
Keywords
cardiovascular and respiratory diseases, hypertensive disorder, primary pulmonary hypertension, rare disease
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Masking
None (Open Label)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
epoprostenol
10. Eligibility
Sex
All
Minimum Age & Unit of Time
0 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
PROTOCOL ENTRY CRITERIA:
Severe primary pulmonary hypertension
Able to prepare and self-administer medication
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Adaani E. Frost
Organizational Affiliation
Baylor College of Medicine
Official's Role
Study Chair
12. IPD Sharing Statement
Learn more about this trial
Phase IV Study of Chronic Infusional Epoprostenol for Severe Primary Pulmonary Hypertension
We'll reach out to this number within 24 hrs