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

PHASE3TerminatedINTERVENTIONAL
Enrollment

207

Participants

Timeline

Start Date

April 30, 2016

Primary Completion Date

August 31, 2018

Study Completion Date

August 31, 2018

Conditions
Pulmonary Arterial Hypertension
Interventions
DRUG

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)

DRUG

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

Trial Locations (109)

1070

Hopital Erasme - Service de Cardiologie, Brussels

1090

AKH-Vienna, Medical University of Vienna, Vienna

2010

St Vincent's Public Hospital, Darlinghurst

2109

Macquarie University Hospital, Sydney

2139

Concord Repatriation General Hospital, Sydney

2747

Nepean Hospital, Kingswood

3000

Universitaire Ziekenhuizen (UZ) Leuven - Gasthuisberg -, Leuven

3049

Universidade de Coimbra - Hospitais da Universidade de Coimbra (H.U.C), Coimbra

4102

Princess Alexandra Hospital, Woolloongabba

5000

Royal Adelaide Hospital, Adelaide

6020

Innsbruck Medical University, University Hospital for Internal Medicine VI, Pneumology, Innsbruck

7000

Royal Hobart Hospital, Hobart

7120

Hospital Universitario Son Espases, Palma de Mallorca

8035

Hospital Universitario Vall d'hebron, Barcelona

8036

Hospital Clinic de Barcelona, Barcelona

10000

University Hospital centre Zagreb, Zagreb

10279

NYU Medical Center, Division Pulmonary, Critical Care and Sleep Medicine, New York

10461

Montefiore Medical Center - Weiler Division, The Bronx

11000

Clinical Center of Serbia Department of Cardiology and Polyclinic, Belgrade

Clinical Center of Serbia, Polyclinic, Pulomology Department, Belgrade

11070

Clinical-Hospital Center Zemun, Belgrade

11080

Clinical Hospital Center Bezanijska Kosa, Belgrade

11215

New York Presbyterian Brooklyn Methodist Hospital - Division of Pulmonary/Critical Care/Sleep, Brooklyn

11501

Winthrop University Hospital, Clinical Trials Center, Mineola

12208

Albany Medical Center, Albany

12683

Unfallkrankenhaus Berlin-Klinik für Innere Medizin/Kardiologie, Berlin

15212

Allegheny Singer Research Institute, Pittsburgh

15706

Complejo Hospitalario Universitario de Santiago de Compostela, Santiago de Compostela

17475

Universitätsmedizin Greifswald Zentrum für innere Medizin Klinik und Poliklinik für Innere Medizin B, Greifswald

18000

Clinical Center of Nis, Clinic for Cardiovascular Diseases, Niš

19140

Temple University Hospital, Philadelphia

20900

Azienda Ospedaliera San Gerardo - Monza, Monza

23229

Pulmonary Associates of Richmond, Richmond

24129

Azienda Ospedaliera Papa Giovanni XXIII, Bergamo

28222

Hospital Universitario Puerta de Hierro - Madrid, Majadahonda

29204

MedTrial, LLC, Columbia

29425

Medical University of South Carolina, Charleston

30060

Wellstar Medical Group - Pulmonary Medicine, Marietta

30106

Piedmont Healthcare Pulmonary and Critical Care Research, Austell

30342

Pulmonary and Critical Care of Atlanta, Atlanta

30625

Medizinische Hochschule Hannover-Abteilung für Pneumologie, Hanover

33331

Cleveland Clinic Florida, Weston

34295

Hôpital Arnaud De Villeneuve - Service des Maladies Respiratoires, Montpellier

34741

Pulmonary Disease Specialists, PA, Kissimmee

35020

Hospital Universitario de Gran Canaria Dr. Negrin, Las Palmas de Gran Canaria

38043

Centre Hospitalier Universitaire de Grenoble (CHU Grenoble) - Clinique de Pneumologie, Grenoble

39008

Hospital Universitario Marques de Valdecilla (HUMV), Santander

42270

Centre Hospitalier Universitaire de Saint Etienne, Saint-Priest-en-Jarez

43065

The Ohio State University, Columbus

44195

Cleveland Clinic, Cleveland

45004

Hospital Virgen de la Salud (HVS), Toledo

47003

Hospital Universitario de Valladolid, Valladolid

49094

Dnipropetrovsk Regional Clinical Center of Cardiology and Cardiac Surgery of Dnipropetrovsk Regional Council, Department of Cardiology, Dnipro

49100

Rabin Medical Center, Petah Tikva

53226

Medical College of Wisconsin, Milwaukee

57108

Sioux Falls Cardiovascular, Sioux Falls

58100

The Edith Wolfson Medical Center, Holon

60611

Bluhm Cardiovascular Institute, Clinical Trials Unit, Chicago

61035

"Municipal Institution of health care Kharkiv City Clinical Hospital №13, Pulmonology Department №1", Kharkiv

61039

"Government Institution L.T.Malaya Therapy National Institute of the National Academy of Medical Sciences of Ukraine, Cardiopulmonology Department", Kharkiv

61616

HeartCare Midwest, Peoria

69126

Thoraxklinik am Universitätsklinikum Heidelberg-Zentrum für Pulmonale Hypertension, Heidelberg

76031

Centre Hospitalier Universitaire (CHU) Hopitaux de Rouen - Hopital Charles Nicolle, Rouen

79010

Lviv Regional Clinical Hospital, Department of Intesive Care #2, Lviv

79106

"Universitätsklinikum Freiburg - Medizinische Universitätsklinik", Freiburg im Breisgau

80045

University of Colorado Denver, Aurora

84101

Soroka Medical Center, Beersheba

85012

Arizona Pulmonary Specialists, Ltd, Phoenix

88239

Waldburg-Zeil Kliniken - Fachkliniken Wangen Klinik für Pneumologie, Wangen

90073

West Los Angeles VA Healthcare Center, Los Angeles

90127

Istituto Mediterraneo per i Trapianti e Terapie ad Alta Specializzazione, Palermo

90211

Cedars-Sinai Medical Center, Beverly Hills

92093

UC San Diego / Pulmonary, Critical Care and Sleep Medicine Division, La Jolla

93053

Klinikum der Universität Regensburg - Klinik und Poliklinik für Innere Medizin II, Regensburg

95817

University of California, Davis Medical Center, Sacramento

97210

Legacy Medical Group - Pulmonary Clinic, Portland

97220

The Oregon Clinic, PC, Portland

99089

Helios Klinikum Erfurt, Erfurt

3436212

Carmel Medical Center, Haifa

4428164

Meir Medical Center - Pulmonology Dept., Kfar Saba

5265601

Sheba Medical Center, Ramat Gan

7830604

Barzilai University Medical Center, Ashkelon

85724-5046

University of Arizona Sarver Heart Center, Tucson

32803-5727

Central Florida Pulmonary Group, PA, Orlando

40202-1332

Kentuckiana Pulmonary Associates (KPA), Inc. - Louisville, Louisville

02115

Brigham and Women's Hospital, Boston

68198-5590

University of Nebraska Medical Center, Omaha

45267-0564

University of Cincinnati Medical Ctr, Dept of Internal Medicine / Pulmonary, Critical Care & Sleep Medicine, Cincinnati

75390-8550

University of Texas Southwestern Medical Center of Dallas, Dallas

53792-1615

University of Wisconsin, Madison

T1Y 6J4

Faculty of Medicine / Peter Lougheed Center / Respiratory Research, Calgary

N6A 5W9

Lawson Clinical Research Services / London Health Sciences Centre - VH, London

M5G 2C4

Toronto General Hospital, University Health Network, Toronto

Unknown

Fundación Abood Shaio, Bogotá

Hadassah University Medical Center, Jerusalem

128 02

Vseobecna Fakultni Nemocnice v Praze (VFN), Prague

06001

CHU de Nice Hôpital Pasteur - Pavillon H - Service Pneumologie, Nice

01307

Technische Universitaet Dresden - Universitaetsklinikum Carl Gustav Carus - Medizinische Klinik und Poliklinik I, Dresden

04103

Universitätsklinikum Leipzig-Dept. für Innere MedizinAbteilung für Pneumologie, Leipzig

00161

A.O.U. Policlinico Umberto I- Università La Sapienza, Roma

1081 HV

Vrije Universiteit Medisch Centrum (VUMC), Amsterdam

2801-951

Hospital Garcia de Orta, Almada

1649-035

Centro Hospitalar de Lisboa Norte - Hospital de Santa Maria, Lisbon

03680

National institute of phthisiology and pulmonology, Kyiv

"National Scientific Centre M.D. STRAZHESKO INSTITUTE OF CARDIOLOGY, MAS OF UKRAINE", Kyiv

NE7 7DN

Freeman Hospital, Newcastle upon Tyne

G81 4DY

Golden Jubilee National Hospital, Clydebank

NW3 3QG

Royal Free Hospital, London

SW3 6NP

Royal Brompton Hospital, London

Sponsors
All Listed Sponsors
collaborator

Worldwide Clinical Trials

OTHER

lead

Bellerophon Pulse Technologies

INDUSTRY