NCT02436512

Study to Assess Acute Vasodilation Response of Inhaled Nitric Oxide

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• Status: Withdrawn
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Geno LLC · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

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.

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.

Conditions

• Pulmonary Arterial Hypertension

Interventions

Type	Name	Description
DRUG	Inhaled Nitric Oxide	The investigational product is inhaled nitric oxide delivered via nasal cannula or venturi mask with the GeNOsylTM Delivery System or GeNOsylTM Acute DS, during RHC as follows: * (Dose 1): 5 ppm inhaled nitric oxide for 15 minutes * (Dose 2): 40 ppm inhaled nitric oxide for 15 minutes

Timeline

• Start date: 2015-06-01
• Primary completion: 2015-08-01
• Completion: 2015-08-01
• First posted: 2015-05-06
• Last updated: 2015-09-07

Locations

2 sites across 1 country: United States