Ignite Creation Date:
2024-05-06 @ 4:02 AM
Last Modification Date:
2024-10-26 @ 11:42 AM
Study NCT ID:
NCT02436512
Status:
WITHDRAWN
Last Update Posted:
2015-09-07
First Post:
2015-04-13
Brief Title:
Study to Assess Acute Vasodilation Response of Inhaled Nitric Oxide
Sponsor:
Geno LLC
Organization:
Geno LLC
Study Overview
Official Title:
A Phase 3 Open-label Multi-Center Two-Part Single-arm Study to Evaluate the Acute Vasodilation Response of Inhaled Nitric Oxide as a Predictor of Successful Wean From Parental Prostacyclins in Subjects With Pulmonary Arterial Hypertension
Status:
WITHDRAWN
Status Verified Date:
2015-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Inability meet enrollment in study population
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
EAGLE
Brief Summary:
The EAGLE study is a Phase 3 open-label multi-center two-part single-arm study of GeNOsylR delivery systems to evaluate if inhaled nitric oxide-induced vasodilation predicts successful wean from parenteral prostacyclin PGI in subjects with World Health Organization WHO Group 1 pulmonary arterial hypertension PAH undergoing a medically necessary right heart catheterization RHC All subjects enrolled in the study will undergo an attempt to wean from parenteral PGI per standard of care
Detailed Description:
This study will be divided into 2 parts a Pilot Phase followed by Pivotal Phase
The Pilot Phase will enroll up to 20 subjects The information derived from the Pilot Phase will evaluate safety and assess the vasoreactivity test response rate
Approximately 150 subjects will be enrolled in the Pivotal Phase of the study to gather further data on weaned successes from parenteral PGI The Investigator and study staff involved with the wean and patient management will be blinded in this phase of the study to the vasoreactivity results
The Pilot Phase will enroll up to 20 subjects The information derived from the Pilot Phase will evaluate safety and assess the vasoreactivity test response rate
Approximately 150 subjects will be enrolled in the Pivotal Phase of the study to gather further data on weaned successes from parenteral PGI The Investigator and study staff involved with the wean and patient management will be blinded in this phase of the study to the vasoreactivity results
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None