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

• Sponsor: National Center for Research Resources (NCRR) (NIH)
• Overall Status: Completed
• CT.gov ID: NCT00004754
• Collaborator: Baylor College of Medicine (Other)

Study Details

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.

1. 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

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.

Study Design

• Study Type: Interventional
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Study Start Date: Aug 1, 1993

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

• Ages Eligible for Study: 0 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

PROTOCOL ENTRY CRITERIA:

• Severe primary pulmonary hypertension

• Able to prepare and self-administer medication

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• National Center for Research Resources (NCRR)
• Baylor College of Medicine

Investigators

• Study Chair: Adaani E. Frost, Baylor College of Medicine

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00004754
• Other Study ID Numbers: 199/11678; BCM-P1850
• First Posted: Feb 25, 2000
• Last Update Posted: Jun 24, 2005
• Last Verified: Dec 1, 2001

• Keywords provided by , ,: cardiovascular and respiratory diseases; hypertensive disorder; primary pulmonary hypertension; rare disease
• Additional relevant MeSH terms: Hypertension, Pulmonary; Familial Primary Pulmonary Hypertension; Hypertension; Epoprostenol; Tezosentan

Study Results

No Results Posted as of Jun 24, 2005