Clinical Study of Pulsed, Inhaled Nitric Oxide Versus Placebo in Symptomatic Subjects With PAH

Summary

Phase 3, placebo controlled, double-blind, randomized clinical study to determine safety, tolerability, and efficacy of pulsed, inhaled nitric oxide (iNO) versus placebo in symptomatic subjects with pulmonary arterial hypertension (PAH). Part 1 and Part 2

Timeline

Start

2016-04

Primary completion

2018-08

Completion

2018-08

Outcome

Missed primary endpoint

Stopped: “Trial stopped for futility”

registry analysis (superiority test); Inhaled Nitric Oxide 75mcg/KgIBW/Hr vs Placebo; p = 0.87; Mean Difference (Final Values) 1.99 (95% CI -22.47 to 26.45); Mixed Models Analysis NCT02725372 ↗

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Nitric Oxide	Other / unclassified	75 ug/kg	Inhaled

Indications