drugset / Trial / NCT02436512

Study to Assess Acute Vasodilation Response of Inhaled Nitric Oxide

NCT02436512

Phase 3 Withdrawn Geno LLC
NaSingle-groupOpen-labelDiagnostic

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.

Timeline

Start
2015-06
Primary completion
2015-08
Completion
2015-08

Drugs

EvaluationDrugModalityDoseRoute
Subject Nitric Oxide Other / unclassified 5 ppm Inhaled
Subject Nitric Oxide Other / unclassified 40 ppm Inhaled