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.
Men and women age 18 and older, with:
Detailed eligibility requirements will be reviewed when you contact the study team.
Melissa D. Ricketts, CCRC, phone 212-746-2698, email email@example.com
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). ClinicalTrials.gov Identifier NCT01457781