207
Participants
Start Date
April 30, 2016
Primary Completion Date
August 31, 2018
Study Completion Date
August 31, 2018
Inhaled Nitric Oxide 75 mcg/kg IBW/hr
Inhaled Nitric Oxide 15mcg/Kg IBW/hr for two week run in period dose titrated to Inhaled Nitric Oxide 75 mcg/kg IBW/hr at randomizationTreatment Period (Week 3 to Week 18)
Placebo
Part 1 Placebo arm: Inhaled Nitric Oxide 15mcg/Kg IBW/hrfor two week run in period dose titrated to Inhaled Nitric Oxide 75 mcg/kg IBW/hr at randomizationTreatment Period
Hopital Erasme - Service de Cardiologie, Brussels
AKH-Vienna, Medical University of Vienna, Vienna
St Vincent's Public Hospital, Darlinghurst
Macquarie University Hospital, Sydney
Concord Repatriation General Hospital, Sydney
Nepean Hospital, Kingswood
Universitaire Ziekenhuizen (UZ) Leuven - Gasthuisberg -, Leuven
Universidade de Coimbra - Hospitais da Universidade de Coimbra (H.U.C), Coimbra
Princess Alexandra Hospital, Woolloongabba
Royal Adelaide Hospital, Adelaide
Innsbruck Medical University, University Hospital for Internal Medicine VI, Pneumology, Innsbruck
Royal Hobart Hospital, Hobart
Hospital Universitario Son Espases, Palma de Mallorca
Hospital Universitario Vall d'hebron, Barcelona
Hospital Clinic de Barcelona, Barcelona
University Hospital centre Zagreb, Zagreb
NYU Medical Center, Division Pulmonary, Critical Care and Sleep Medicine, New York
Montefiore Medical Center - Weiler Division, The Bronx
Clinical Center of Serbia Department of Cardiology and Polyclinic, Belgrade
Clinical Center of Serbia, Polyclinic, Pulomology Department, Belgrade
Clinical-Hospital Center Zemun, Belgrade
Clinical Hospital Center Bezanijska Kosa, Belgrade
New York Presbyterian Brooklyn Methodist Hospital - Division of Pulmonary/Critical Care/Sleep, Brooklyn
Winthrop University Hospital, Clinical Trials Center, Mineola
Albany Medical Center, Albany
Unfallkrankenhaus Berlin-Klinik für Innere Medizin/Kardiologie, Berlin
Allegheny Singer Research Institute, Pittsburgh
Complejo Hospitalario Universitario de Santiago de Compostela, Santiago de Compostela
Universitätsmedizin Greifswald Zentrum für innere Medizin Klinik und Poliklinik für Innere Medizin B, Greifswald
Clinical Center of Nis, Clinic for Cardiovascular Diseases, Niš
Temple University Hospital, Philadelphia
Azienda Ospedaliera San Gerardo - Monza, Monza
Pulmonary Associates of Richmond, Richmond
Azienda Ospedaliera Papa Giovanni XXIII, Bergamo
Hospital Universitario Puerta de Hierro - Madrid, Majadahonda
MedTrial, LLC, Columbia
Medical University of South Carolina, Charleston
Wellstar Medical Group - Pulmonary Medicine, Marietta
Piedmont Healthcare Pulmonary and Critical Care Research, Austell
Pulmonary and Critical Care of Atlanta, Atlanta
Medizinische Hochschule Hannover-Abteilung für Pneumologie, Hanover
Cleveland Clinic Florida, Weston
Hôpital Arnaud De Villeneuve - Service des Maladies Respiratoires, Montpellier
Pulmonary Disease Specialists, PA, Kissimmee
Hospital Universitario de Gran Canaria Dr. Negrin, Las Palmas de Gran Canaria
Centre Hospitalier Universitaire de Grenoble (CHU Grenoble) - Clinique de Pneumologie, Grenoble
Hospital Universitario Marques de Valdecilla (HUMV), Santander
Centre Hospitalier Universitaire de Saint Etienne, Saint-Priest-en-Jarez
The Ohio State University, Columbus
Cleveland Clinic, Cleveland
Hospital Virgen de la Salud (HVS), Toledo
Hospital Universitario de Valladolid, Valladolid
Dnipropetrovsk Regional Clinical Center of Cardiology and Cardiac Surgery of Dnipropetrovsk Regional Council, Department of Cardiology, Dnipro
Rabin Medical Center, Petah Tikva
Medical College of Wisconsin, Milwaukee
Sioux Falls Cardiovascular, Sioux Falls
The Edith Wolfson Medical Center, Holon
Bluhm Cardiovascular Institute, Clinical Trials Unit, Chicago
"Municipal Institution of health care Kharkiv City Clinical Hospital №13, Pulmonology Department №1", Kharkiv
"Government Institution L.T.Malaya Therapy National Institute of the National Academy of Medical Sciences of Ukraine, Cardiopulmonology Department", Kharkiv
HeartCare Midwest, Peoria
Thoraxklinik am Universitätsklinikum Heidelberg-Zentrum für Pulmonale Hypertension, Heidelberg
Centre Hospitalier Universitaire (CHU) Hopitaux de Rouen - Hopital Charles Nicolle, Rouen
Lviv Regional Clinical Hospital, Department of Intesive Care #2, Lviv
"Universitätsklinikum Freiburg - Medizinische Universitätsklinik", Freiburg im Breisgau
University of Colorado Denver, Aurora
Soroka Medical Center, Beersheba
Arizona Pulmonary Specialists, Ltd, Phoenix
Waldburg-Zeil Kliniken - Fachkliniken Wangen Klinik für Pneumologie, Wangen
West Los Angeles VA Healthcare Center, Los Angeles
Istituto Mediterraneo per i Trapianti e Terapie ad Alta Specializzazione, Palermo
Cedars-Sinai Medical Center, Beverly Hills
UC San Diego / Pulmonary, Critical Care and Sleep Medicine Division, La Jolla
Klinikum der Universität Regensburg - Klinik und Poliklinik für Innere Medizin II, Regensburg
University of California, Davis Medical Center, Sacramento
Legacy Medical Group - Pulmonary Clinic, Portland
The Oregon Clinic, PC, Portland
Helios Klinikum Erfurt, Erfurt
Carmel Medical Center, Haifa
Meir Medical Center - Pulmonology Dept., Kfar Saba
Sheba Medical Center, Ramat Gan
Barzilai University Medical Center, Ashkelon
University of Arizona Sarver Heart Center, Tucson
Central Florida Pulmonary Group, PA, Orlando
Kentuckiana Pulmonary Associates (KPA), Inc. - Louisville, Louisville
Brigham and Women's Hospital, Boston
University of Nebraska Medical Center, Omaha
University of Cincinnati Medical Ctr, Dept of Internal Medicine / Pulmonary, Critical Care & Sleep Medicine, Cincinnati
University of Texas Southwestern Medical Center of Dallas, Dallas
University of Wisconsin, Madison
Faculty of Medicine / Peter Lougheed Center / Respiratory Research, Calgary
Lawson Clinical Research Services / London Health Sciences Centre - VH, London
Toronto General Hospital, University Health Network, Toronto
Fundación Abood Shaio, Bogotá
Hadassah University Medical Center, Jerusalem
Vseobecna Fakultni Nemocnice v Praze (VFN), Prague
CHU de Nice Hôpital Pasteur - Pavillon H - Service Pneumologie, Nice
Technische Universitaet Dresden - Universitaetsklinikum Carl Gustav Carus - Medizinische Klinik und Poliklinik I, Dresden
Universitätsklinikum Leipzig-Dept. für Innere MedizinAbteilung für Pneumologie, Leipzig
A.O.U. Policlinico Umberto I- Università La Sapienza, Roma
Vrije Universiteit Medisch Centrum (VUMC), Amsterdam
Hospital Garcia de Orta, Almada
Centro Hospitalar de Lisboa Norte - Hospital de Santa Maria, Lisbon
National institute of phthisiology and pulmonology, Kyiv
"National Scientific Centre M.D. STRAZHESKO INSTITUTE OF CARDIOLOGY, MAS OF UKRAINE", Kyiv
Freeman Hospital, Newcastle upon Tyne
Golden Jubilee National Hospital, Clydebank
Royal Free Hospital, London
Royal Brompton Hospital, London
Lead Sponsor
Collaborators (1)
Worldwide Clinical Trials
OTHER
Bellerophon Pulse Technologies
INDUSTRY