Ignite Creation Date:
2024-05-05 @ 11:21 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00004754
Status:
COMPLETED
Last Update Posted:
2005-06-24
First Post:
2000-02-24
Brief Title:
Phase IV Study of Chronic Infusional Epoprostenol for Severe Primary Pulmonary Hypertension
Sponsor:
National Center for Research Resources NCRR
Organization:
Office of Rare Diseases ORD
Study Overview
Official Title:
None
Status:
COMPLETED
Status Verified Date:
2001-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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
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 Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| BCM-P1850 | None | None | None |