Study Status: 
Study Description: 

This clinical trial is for men and women who are being treated for with Pulmonary Hypertension (PH) or pulmonary arterial hypertension (PAH) but continue to experience symptoms such as  shortness of breath during exertion, dizziness, or fainting spells.

The purpose of this study is to evaluate the use of inhaled nitric oxide (iNO) with a pulsed delivery device (INOpulse DS). Similar treatments are approved only for conditions found in newborn babies.

There are two parts to this study. For the first 16 weeks, subjects are randomized to receive either one of  two doses of iNO delivered by a pulsed delivery device, or a placebo. All subjects who complete this part of the study are eligible to enter an extended study in which all subjects receive iNO. This part of the study continues until the entire study is closed.

Key Eligibility: 

Men and women age 18 and older, with:

  • A confirmed diagnosis of Pulmonary Hypertension Group 1 (PAH)
  • 6 minute walk between 100 meters and 450 meters
  • At least one approved PAH therapy
  • Clinical symptoms from PAH, e.g., onset or increased dyspnea on exertion, dizziness, near-syncope, syncope, chest pain or peripheral edema
  • No diagnosis of Pulmonary Hypertension Group 2, 3, 4, or 5
  • No left ventricular systolic dysfunction, i.e., no LVEF < 40% or LVSF < 22%
  • No significant cardiomyopathy or valvular heart disease

Detailed eligibility requirements will be reviewed when you contact the study team.

Principal Investigator: 
Evelyn Horn, M.D.

Melissa D. Ricketts, CCRC, phone 212-746-2698, email

Ikaria, Inc.
Official Title: 

A Phase 2, Placebo Controlled, Double-Blind, Randomized, Clinical Study to Determine Safety, Tolerability and Efficacy of Pulsed, Inhaled Nitric Oxide (iNO) Versus Placebo as Add-On Therapy in Symptomatic Subjects With Pulmonary Arterial Hypertension (PAH). Identifier NCT01457781

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