Study to Assess Acute Vasodilation Response of Inhaled Nitric Oxide

Withdrawn before enrolling · Phase 3

Conditions studied: Pulmonary Arterial Hypertension

In brief

The EAGLE study is a Phase 3, open-label, multi-center, two-part, single-arm study of GeNOsyl(R) delivery system(s) 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.

Key facts

Study ID

NCT02436512

Run by

Geno LLC

People needed

0

Starts

2015-06-01

Expected to finish

2015-08-01

Last updated by the study team

2015-09-07

Who can join

Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• The subject or subject's legally authorized representative signs and dates an Institutional Review Board (IRB) approved informed consent form prior to the initiation of any study-related activities.
• The subject has been diagnosed with PAH (WHO Group 1) and is WHO Functional Class I or II at Screening.
• The subject has documented continuous PGI use for ≥ 1 year from Screening, without a significant interruption (i.e., ≤ 2 day interruption) and without a failed complete wean attempt.
• The subject is a candidate for weaning off parenteral PGI therapy (per Investigator judgment and standard of care).

You may not qualify if…

• The subject has a hypersensitivity or allergy to ingredients of inhaled nitric oxide or other clinically significant allergies (clinical significance per Investigator judgment).
• The subject has a PCWP or left ventricular end diastolic pressure (LVEDP) ≥15 mmHg at Baseline.
• The subject has participated in an investigational product or device study within the 30 days prior to Screening.

Where it is running

• University of Alabama — Birmingham, Alabama, United States
• Allegheny General Hospital — Pittsburgh, Pennsylvania, United States

Full record on ClinicalTrials.gov

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