80
Participants
Start Date
April 30, 2012
Primary Completion Date
October 31, 2014
Study Completion Date
July 31, 2016
Inhaled Nitric Oxide 0.025 mg/kg IBW/hr delivered via INOpulse DS Device
Cohort 1: 0.025 mg/kg IBW/hr for up to 24 hours/day x 16 weeks (3.0 mg/L \[2440 ppm\] NO mini-cylinder; change q 24 hours) delivered via INOpulse DS Device and INOpulse DS nasal cannula
Placebo delivered via INOpulse DS Device
Placebo 0.075 mg/kg IBW/hr for up to 24 hours/day x 16 weeks (Nitrogen N2, 99.999%) delivered via INOpulse DS Device and INOpulse DS nasal cannula
Inhaled nitric oxide 0.075 mg/kg IBW/hr delivered via INOpulse DS Device
Cohort 2: 0.075 mg/kg IBW/hr for up to 24 hours/day x 16 weeks (6.0 mg/L \[4880 ppm\] NO mini-cylinder; change q 24 hours) delivered via INOpulse DS Device and INOpulse DS nasal cannula
Beth Israel Medical Center, New York
Weill Cornell Medical Center, New York
Montefiore Medical Center, The Bronx
Allegheny Singer Research Institute/Allegheny General Hospital, Pittsburgh
Temple University Hospital, Philadelphia
Christiana Care Health System, Newark
University of Maryland Medical Center, Baltimore
Duke University Medical Center, Durham
Emory University Hospital-Emory Clinic, Atlanta
University of Florida College of Medicine, Jacksonville
Cleveland Clinic Florida, Weston
Kentuckiana Pulmonary Associates, Louisville
University of Kentucky Gill Heart, Lexington
Ohio State University Martha Morehouse Medical Pavillion, Columbus
University Hospitals Case Medical Center, Cleveland
Cleveland Clinic, Cleveland
UC Health/University of Cincinnati, Cincinnati
University of Michigan, Ann Arbor
University of Iowa Hospitals & Clinics, Iowa City
Aurora St. Luke's Medical Center, Milwaukee
University of Minnesota, Cardiovascular Division, Minneapolis
Mayo Clinic, Rochester
Sioux Falls Cardiovascular PC, Sioux Falls
Washington University School of Medicine, St Louis
University of Kansas Medical Center, Kansas City
LSUHSC-New Orleans, New Orleans
South Oklahoma Heart Research LLC, Oklahoma City
University of Texas Southwestern Medical Center, Dallas
Baylor College of Medicine, Houston
Children's Hospital Colorado, Aurora
University of Colorado Denver, Aurora
South Denver Cardiology Associates P.C., Littleton
Intermountain Medical Center, Murray
Arizona Pulmonary Specialists, Phoenix
West Los Angeles VA Healthcare Center, Los Angeles
David Geffen School of Medicine at UCLA, Los Angeles
Los Angeles Biomedical Research Institute at Harbor-UCLA Med Ctr, Torrance
Allianz Research Institute, Inc., Fountain Valley
University of California, San Francisco-Fresno, Fresno
Legacy Medical Group - Pulmonary Clinic, Portland
University of Alabama at Birmingham, Birmingham
Tufts Medical Center, Boston
Boston University Medical Center/Boston University School of Medicine, Boston
Dartmouth-Hitchcock Medical Center, Lebanon
University of Medicine and Dentistry of NJ, Newark
Barnabas Health Newark Beth Israel Medical Center, Newark
Rhode Island Hospital, Providence
Peter Lougheed Center, Calgary
ABACUS - University of Alberta Hospitals, Edmonton
London Health Sciences Centre, London
University Health Network - Toronto General Hospital, Toronto
Lead Sponsor
Bellerophon Pulse Technologies
INDUSTRY