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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Study Classification

INTERVENTIONAL

Study Start Date

1993-08-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Hypertension, Pulmonary

Keywords

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cardiovascular and respiratory diseases hypertensive disorder primary pulmonary hypertension rare disease

Study Design

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Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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epoprostenol

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

PROTOCOL ENTRY CRITERIA:

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

Minimum Eligible Age

0 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Principal Investigators

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Adaani E. Frost

Role: STUDY_CHAIR

Baylor College of Medicine

Other Identifiers

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BCM-P1850

Identifier Type: -

Identifier Source: secondary_id

199/11678