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Clinical Study of Pulsed, Inhaled Nitric Oxide Versus Placebo in Symptomatic Subjects With PAH (INOvation-1)

This study is currently recruiting participants.
Verified August 2017 by Bellerophon ( Bellerophon Pulse Technologies )
Sponsor:
ClinicalTrials.gov Identifier:
NCT02725372
First Posted: April 1, 2016
Last Update Posted: August 17, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Collaborator:
Worldwide Clinical Trials
Information provided by (Responsible Party):
Bellerophon ( Bellerophon Pulse Technologies )
  Purpose
Phase 3, placebo controlled, double-blind, randomized clinical study to determine safety, tolerability, and efficacy of pulsed, inhaled nitric oxide (iNO) versus placebo in symptomatic subjects with pulmonary arterial hypertension (PAH). Part 1 and Part 2

Condition Intervention Phase
Pulmonary Arterial Hypertension Drug: Inhaled Nitric Oxide 75 mcg/kg IBW/hr Drug: Placebo Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase 3, Placebo Controlled, Double-Blind, Randomized, Clinical Study to Determine Efficacy, Safety, and Tolerability of Pulsed, Inhaled Nitric Oxide (iNO) Versus Placebo in Symptomatic Subjects With PAH (Part 1 and Part 2)

Resource links provided by NLM:


Further study details as provided by Bellerophon ( Bellerophon Pulse Technologies ):

Primary Outcome Measures:
  • Six Minute Walk Distance (6MWD) - Change from baseline 6MWD at 18 Weeks [ Time Frame: Change from baseline to 18 weeks ]
    Change in 6MWD from baseline to 18 weeks


Secondary Outcome Measures:
  • Time to Clinical Worsening (TTCW) [ Time Frame: baseline to 18 weeks ]

    1. TTCW, the time (in days) from start of treatment to first event (first day the event is noted), with iNO as compared to placebo, measured from baseline to 18 weeks . TTCW event is defined as any of the following:

    1. Death (all-cause mortality)
    2. Atrial septostomy
    3. Hospitalization due to worsening of PAH (adjudicated)
    4. Start of new specific PAH TX (endothelin receptor antagonists [ERAs], phosphodiesterase type-5 [PDE-5] inhibitors or prostanoids), an increase in the dose of an ERA or PDE-5, increase in the dose or frequency of an inhaled prostanoids, or an increase in the dose of an intravenous or subcutaneous prostanoids by >10%.
    5. Decrease of >15% from baseline or >30% compared with the last study related measurement in 6MWD should be confirmed by a repeat measurement performed at least 14 days later
    6. Worsening of WHO Functional Class (e.g., from Class II to Class III or IV, OR Class III to Class IV); and confirmed by a repeat assessment at least 14 days later

  • Change in World Health Organization (WHO) Functional Class [ Time Frame: from baseline to 18 weeks ]
    Change in World Health Organization (WHO) Functional Class from baseline to 18 weeks


Other Outcome Measures:
  • Change in health-related quality of life using Short Form-36 (SF-36) version 2 health survey [ Time Frame: from baseline to 18 weeks ]
    Change in QOL SF36 from Baseline to 18 weeks

  • Change in Pulmonary Hemodynamics [ Time Frame: from baseline to 18 weeks ]
    Change in pulmonary hemodynamics (i.e., cardiac output [CO], cardiac index [CI], mean pulmonary artery pressure [mPAP], mean pulmonary capillary wedge pressure [mPCWP], systolic pulmonary artery pressure [sPAP], diastolic pulmonary artery pressure [dPAP], pulmonary vascular resistance [PVR], and oxygen saturation by pulse oximeter [SpO2], mixed venous O2, and right atrial pressure [RAP]), measured by right heart catheterization (RHC), with iNO as compared to placebo, from baseline to 18 weeks, in a subset of subjects (approximately 50), at selected sites

  • Change in Echocardiogram measurements [ Time Frame: from baseline to 18 weeks ]
    Change in echocardiogram measurements right ventricular function (including right ventricular fractional area change, systolic pulmonary artery pressure [sPAP], tricuspid annular motion/tricuspid annular plane systolic excursion, tricuspid annular systolic velocity, and Tei index) and left ventricular function (including left ventricular ejection fraction [LVEF], LV size, and improvement in LV early diastolic relaxation velocity), with iNO as compared to placebo, from baseline to 18 weeks, in a subset of subjects (approximately 50), at selected sites

  • Change in Prop BNP [ Time Frame: from screening to 18 weeks ]
    as compared to placebo from screening to 18 weeks

  • Change in Borg Dyspnea Scale [ Time Frame: from baseline to 18 weeks ]
    immediately following 6MWT with iNO as compared to Placebo from baseline, to 18weeks

  • Change in 6MWD [ Time Frame: from baseline to 18weeks ]
    as related to degree of drug adherence, with iNO as compared to placebo,

  • Unsatisfactory Clinical Response [ Time Frame: from baseline to 18weeks ]
    Number of subjects with unsatisfactory clinical response, with iNO as compared to placebo, from baseline to 18 weeks. Defined as WHO Functional Class III or IV symptoms with no improvement

  • Subjects undergoing heart-lung or lung transplant [ Time Frame: from baseline to 18weeks ]
    Number of subjects undergoing heart-lung or lung transplantation, number of subjects listed for transplantation, deaths while awaiting transplant, from baseline to 18 week

  • Medical Resource Utilization [ Time Frame: from baseline to 18 weeks ]
    Economic evaluation of the use as compared to placebo from baseline to 18weeks and baseline to EOS. Number of hospitalizations, Er visits and outpatient visits in the previous year as compared to study duration. Frequency duration and diagnosis will be recorded.


Estimated Enrollment: 188
Actual Study Start Date: April 2016
Estimated Study Completion Date: December 2018
Estimated Primary Completion Date: July 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Inhaled Nitric Oxide 75mcg/KgIBW/Hr

Part 1:

15Mcg/kg IBW/hr during Run-in Period dose titrated to Inhaled Nitric Oxide / 75mcg/KgIBW/Hr upon randomization to treatment arm.

Part 2: iNO 75 mcg/kg IBW/hr Open Label Treatment

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)
Other Names:
  • Inhaled Nitric Oxide
  • iNO
Placebo Comparator: Placebo

Part 1:

Placebo dose setting 15mcg/kg IBW/hr Run In Period / Placebo dose setting 75 mcg/kg IBW/hr treatment period

Part 2: iNO 75 mcg/kg IBW/hr Open Label Treatment

Drug: Placebo
Placebo arm: Inhaled Nitric Oxide 15mcg/Kg IBW/hr
Other Names:
  • Inhaled Nitric Oxide
  • iNO

Detailed Description:
Phase 3, 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 subjects with pulmonary arterial hypertension (PAH) who remain symptomatic on approved PAH monotherapy or combination approved PAH therapy and long term oxygen therapy (LTOT). (Part 1 and Part 2)
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 85 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Signed Informed Consent Form (and assent as appropriate) prior to the initiation of any study mandated procedures or assessments
  2. A confirmed diagnosis of PAH Group 1 who have either idiopathic PAH (IPAH), heritable PAH, drug and toxin-induced PAH, associated PAH (APAH) with connective tissue disease (CTD), APAH with repaired simple congenital systemic to pulmonary shunt (i.e., atrial septal defect, ventricular septal defect and/or patent ductus arteriosus; complete repair at least 1 year prior to Screening), APAH with human immunodeficiency virus (HIV), or APAH with portal hypertension
  3. Subjects receiving at least one PAH specific therapy (ERA or PDE-5 inhibitor, or inhaled, subcutaneous, or intravenous prostacyclin or a prostacyclin analog) with the same type of therapy for at least 3 months with stable dosing 4 weeks prior to Screening. (Subjects should be receiving optimal therapy according to the disease severity)
  4. Subjects using oxygen therapy by nasal cannula for at least 4 weeks prior to Screening
  5. PAH diagnosis confirmed by RHC within the previous 5 years, according to the following definitions:

    • PVR ≥ 400 dynes.sec.cm-5 (5 Wood units)
    • mPAP ≥ 25 mmHg
    • PCWP or LVEDP ≤ 15 mmHg
    • Subjects who otherwise meet all the inclusion criteria and none of the exclusion criteria but have not undergone a RHC within the previous 5 years may be considered eligible for the study if they undergo a RHC and then meet the pulmonary hemodynamics criterion
  6. 6MWD ≥ 100 meters and ≤ 450 meters prior to randomization
  7. WHO Functional Class II-IV. Subjects with WHO Functional Class IV should be treated with prostacyclin or a prostacyclin analog (subcutaneous or intravenous), plus at least one additional PAH specific therapy (ERA or PDE-5), if available to the subject and reimbursed by health insurance
  8. Age between 18 and 85 years (inclusive)
  9. Willingness to use INOpulse delivery device for at least 12 hours per day
  10. Willingness to continue on study drug until the subject has completed Week 18 assessments (EOS)
  11. Female subjects of childbearing potential must have a negative pre-treatment pregnancy test (serum or urine). All female subjects should take adequate precaution to avoid pregnancy.

Exclusion Criteria:

  1. Subjects with known HIV infection who have a history within the past 3 months of any opportunistic pulmonary disease (e.g., tuberculosis, Pneumocystis carinii pneumonia, or other pneumonias) at the time of Screening
  2. PAH associated with untreated thyroid disorders, glycogen storage disease, Gaucher's disease, hereditary hemorrhagic telangiectasia, hemoglobinopathies, myeloproliferative disorders or splenectomy
  3. Subjects with pulmonary conditions that may contribute to PAH including, but not limited to, chronic bronchiectasis, cystic fibrosis, or other pulmonary condition that the Investigator may deem to contribute to the severity of the disease or impair the delivery of iNO due to airway disease
  4. Subjects receiving riociguat
  5. Subjects receiving oral prostanoids as monotherapy
  6. PAH associated with significant venous or capillary involvement, known or suspected pulmonary veno-occlusive disease, or pulmonary capillary hemangiomatosis
  7. Any subject with WHO PH Groups 2, 3, 4 or 5
  8. Subjects with any of the following cardiac abnormalities:

    1. Underlying cardiomyopathy or clinically significant aortic or mitral valve disease in the opinion of the investigator
    2. Left ventricular systolic dysfunction (LVSD), i.e., left ventricular ejection fraction (LVEF) < 40% or left ventricular shortening fraction (LVSF) < 22%, as determined by local reading
    3. Current symptomatic coronary artery disease, myocardial infarction within 1 year, or any coronary artery interventions within 6 months
  9. Systemic hypertension defined as systolic blood pressure (SBP) > 160 mmHg and/or diastolic blood pressure (DBP) > 100 mmHg persistent at Screening after a period of rest (treated or untreated)
  10. Subjects with a history of deep vein thrombosis, pulmonary embolism/infarction or prothrombotic disorder must have had chronic thromboembolic pulmonary hypertension (CTEPH) excluded by ventilation/perfusion lung (V/Q) scan
  11. Severe obstructive lung disease defined as both a forced expiratory volume in 1 second/forced vital capacity (FEV1/FVC) < 70% and FEV1 < 55% of predicted value
  12. Moderate to severe restrictive lung disease: total lung capacity (TLC) < 60% of predicted; if TLC 60% to 70% predicted, a high resolution CT scan showing diffuse disease or more than mild patchy disease
  13. Any subject who develops or has developed a PCWP > 20 mmHg during acute vasodilator testing (AVT)
  14. Systemic hypotension defined as SBP < 90 mmHg persistent at Screening after a period of rest
  15. Moderate to severe hepatic impairment, i.e., Child-Pugh Class B or C
  16. On dialysis
  17. Acute or chronic physical impairment (other than dyspnea due to PAH) that would limit the ability to comply with study procedures or adherence to therapy (i.e., 6MWT), including carrying and wearing the pulsed delivery device per study protocol, or medical problem(s) likely to preclude completion of the study
  18. Pregnant or breastfeeding females at Screening
  19. Administered L-arginine within 1 month prior to Screening
  20. Known concomitant life-threatening disease with a life expectancy less than 1 year
  21. Atrial septostomy within 3 months preceding randomization
  22. The concurrent use of the INOpulse device with a continuous positive airway pressure (CPAP), Bilevel positive airway presure BiPAP, or any other positive pressure device.
  23. Use of investigational drugs or devices within 1 month prior to Screening (other than acute vasodilator testing with iNO)
  24. Any underlying medical or psychiatric condition that, in the opinion of the Investigator, makes the subject an unsuitable candidate for the study
  25. Any subject who has been enrolled in any previous clinical study with inhaled NO administered through pulse delivery.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02725372


Contacts
Contact: Deena Peace deena.peace@bellerophon.com
Contact: Deborah Quinn, MD deborah.quinn@bellerophon.com

  Hide Study Locations
Locations
United States, Arizona
Arizona Pulmonary Specialists, Ltd Recruiting
Phoenix, Arizona, United States, 85012
University of Arizona Sarver Heart Center Recruiting
Tucson, Arizona, United States, 85724-5046
United States, California
Cedars-Sinai Medical Center Recruiting
Beverly Hills, California, United States, 90211
West Los Angeles VA Healthcare Center Recruiting
Los Angeles, California, United States, 90073
University of California, Davis Medical Center Recruiting
Sacramento, California, United States, 95817
United States, Colorado
University of Colorado Denver Recruiting
Aurora, Colorado, United States, 80045
United States, Florida
Pulmonary Disease Specialists, PA Recruiting
Kissimmee, Florida, United States, 34741
Central Florida Pulmonary Group, PA Recruiting
Orlando, Florida, United States, 32803-5727
Himanshu Chandarana, MD, PA Withdrawn
Saint Petersburg, Florida, United States, 33710
Cleveland Clinic Florida Recruiting
Weston, Florida, United States, 33331
United States, Georgia
Pulmonary and Critical Care of Atlanta Recruiting
Atlanta, Georgia, United States, 30342
United States, Illinois
Bluhm Cardiovascular Institute, Clinical Trials Unit Recruiting
Chicago, Illinois, United States, 60611
HeartCare Midwest Recruiting
Peoria, Illinois, United States, 61616
United States, Kentucky
Kentuckiana Pulmonary Associates (KPA), Inc. - Louisville Recruiting
Louisville, Kentucky, United States, 40202-1332
United States, New York
Albany Medical Center Recruiting
Albany, New York, United States, 12208
Winthrop University Hospital, Clinical Trials Center Recruiting
Mineola, New York, United States, 11501
Mount Sinai Beth Israel Recruiting
New York, New York, United States, 10003
Montefiore Medical Center - Weiler Division Recruiting
The Bronx, New York, United States, 10461
United States, Ohio
University of Cincinnati Medical Ctr, Dept of Internal Medicine / Pulmonary, Critical Care & Sleep Medicine Recruiting
Cincinnati, Ohio, United States, 45267-0564
Cleveland Clinic Recruiting
Cleveland, Ohio, United States, 44195
The Ohio State University Terminated
Columbus, Ohio, United States, 43065
United States, Oregon
Legacy Medical Group - Pulmonary Clinic Recruiting
Portland, Oregon, United States, 97210
The Oregon Clinic, PC Recruiting
Portland, Oregon, United States, 97220
United States, Pennsylvania
Temple University Hospital Recruiting
Philadelphia, Pennsylvania, United States, 19140
Allegheny Singer Research Institute Recruiting
Pittsburgh, Pennsylvania, United States, 15212
United States, South Carolina
Medical University of South Carolina Recruiting
Charleston, South Carolina, United States, 29425
MedTrial, LLC Recruiting
Columbia, South Carolina, United States, 29204
United States, South Dakota
Sioux Falls Cardiovascular Recruiting
Sioux Falls, South Dakota, United States, 57108
United States, Texas
University of Texas Southwestern Medical Center of Dallas Recruiting
Dallas, Texas, United States, 75390-8550
United States, Virginia
Pulmonary Associates of Richmond Recruiting
Richmond, Virginia, United States, 23229
United States, Wisconsin
University of Wisconsin Recruiting
Madison, Wisconsin, United States, 53792-1615
Medical College of Wisconsin Recruiting
Milwaukee, Wisconsin, United States, 53226
Australia, New South Wales
St Vincent's Public Hospital Recruiting
Darlinghurst, New South Wales, Australia, 2010
Nepean Hospital Recruiting
Kingswood, New South Wales, Australia, 2747
Macquarie University Hospital Recruiting
Sydney, New South Wales, Australia, 2109
Concord Repatriation General Hospital Recruiting
Sydney, New South Wales, Australia, 2139
Australia, Queensland
Princess Alexandra Hospital Recruiting
Woolloongabba, Queensland, Australia, 4102
Australia, South Australia
Royal Adelaide Hospital Recruiting
Adelaide, South Australia, Australia, 5000
Australian Respiratory and Sleep Medicine Institute (ARASMI) Recruiting
Bedford Park, South Australia, Australia, 5042
Australia, Tasmania
Royal Hobart Hospital Recruiting
Hobart, Tasmania, Australia, 7000
Australia, Victoria
The Alfred Hospital Recruiting
Melbourne, Victoria, Australia, 3004
Austria
Innsbruck Medical University, University Hospital for Internal Medicine VI, Pneumology Recruiting
Innsbruck, Tirol, Austria, 6020
AKH-Vienna, Medical University of Vienna Recruiting
Wien, Austria, 1090
Belgium
Universitaire Ziekenhuizen (UZ) Leuven - Gasthuisberg - Recruiting
Leuven, Brabant, Belgium, 3000
Hopital Erasme - Service de Cardiologie Recruiting
Bruxelles, Belgium, 1070
Canada, Alberta
Faculty of Medicine / Peter Lougheed Center / Respiratory Research Recruiting
Calgary, Alberta, Canada, T1Y 6J4
Canada, Ontario
Lawson Clinical Research Services / London Health Sciences Centre - VH Recruiting
London, Ontario, Canada, N6A 5W9
Toronto General Hospital, University Health Network Recruiting
Toronto, Ontario, Canada, M5G 2C4
Czechia
Vseobecna Fakultni Nemocnice v Praze (VFN) Recruiting
Praha 2, Bohemia, Czechia, 128 02
France
Centre Hospitalier Regional et Universitaire (CHRU) de Besancon - L'Hopital Jean Minjoz Recruiting
Besancon, Comte, France, 25000
Centre Hospitalier Universitaire (CHU) Hopitaux de Rouen - Hopital Charles Nicolle Recruiting
Rouen, Normandy, France, 76031
Centre Hospitalier Universitaire de Grenoble (CHU Grenoble) - Clinique de Pneumologie Recruiting
Grenoble, Rhone, France, 38043
Centre Hospitalier Universitaire de Saint Etienne Recruiting
St Priest en Jarez, Rhone, France, 42270
Hôpital Arnaud De Villeneuve - Service des Maladies Respiratoires Recruiting
Montpellier, France, 34295
CHU de Nice Hôpital Pasteur - Pavillon H - Service Pneumologie Recruiting
Nice, France, 06001
Germany
"Universitätsklinikum Freiburg - Medizinische Universitätsklinik Recruiting
Freiburg, Baden-Württemberg, Germany, 79106
Thoraxklinik am Universitätsklinikum Heidelberg-Zentrum für Pulmonale Hypertension Recruiting
Heidelberg, Baden-Württemberg, Germany, 69126
Waldburg-Zeil Kliniken - Fachkliniken Wangen Klinik für Pneumologie Recruiting
Wangen, Baden-Württemberg, Germany, 88239
Klinikum der Universität Regensburg - Klinik und Poliklinik für Innere Medizin II Recruiting
Regensburg, Bayern, Germany, 93053
Universitätsmedizin Greifswald Zentrum für innere Medizin Klinik und Poliklinik für Innere Medizin B Recruiting
Greifswald, Mecklenburg-Vorpommern, Germany, 17475
Medizinische Hochschule Hannover-Abteilung für Pneumologie Recruiting
Hannover, Niedersachsen, Germany, 30625
Technische Universitaet Dresden - Universitaetsklinikum Carl Gustav Carus - Medizinische Klinik und Poliklinik I Recruiting
Dresden, Sachsen, Germany, 01307
Universitätsklinikum Leipzig-Dept. für Innere MedizinAbteilung für Pneumologie Recruiting
Leipzig, Sachsen, Germany, 04103
Helios Klinikum Erfurt Recruiting
Erfurt, Thüringen, Germany, 99089
Unfallkrankenhaus Berlin-Klinik für Innere Medizin/Kardiologie Recruiting
Berlin, Germany, 12683
Universitätsklinikum Hamburg-Eppendorf Onkologisches Zentrum II. Medizinische Klinik und Poliklinik Recruiting
Hamburg, Germany, 20246
Israel
Barzilai University Medical Center Recruiting
Ashqelon, Israel, 7830604
Soroka Medical Center Recruiting
Beer Sheba, Israel, 84101
The Edith Wolfson Medical Center Recruiting
Holon, Israel, 58100
Meir Medical Center - Pulmonology Dept. Recruiting
Kfar Saba, Israel, 4428164
Rabin Medical Center Recruiting
Petaẖ Tiqwa, Israel, 49100
Italy
Azienda Ospedaliera Papa Giovanni XXIII Recruiting
Bergamo, BG, Italy, 24129
Azienda Ospedaliera San Gerardo - Monza Recruiting
Monza, MI, Italy, 20900
A.O.U. Policlinico Umberto I- Università La Sapienza Recruiting
Roma, RM, Italy, 00161
Netherlands
Vrije Universiteit Medisch Centrum (VUMC) Recruiting
Amsterdam, Netherlands, 1081 HV
Portugal
Hospital Garcia de Orta Recruiting
Almada, Lisbon, Portugal, 2801-951
Universidade de Coimbra - Hospitais da Universidade de Coimbra (H.U.C) Not yet recruiting
Coimbra, Mondego, Portugal, 3049
Centro Hospitalar de Lisboa Norte - Hospital de Santa Maria Recruiting
Lisbon, Portugal, 1649-035
Serbia
Clinical Center of Serbia Department of Cardiology and Polyclinic Recruiting
Belgrade, Serbia, 11000
Clinical Center of Serbia, Polyclinic, Pulomology Department Recruiting
Belgrade, Serbia, 11000
Clinical-Hospital Center Zemun Recruiting
Belgrade, Serbia, 11070
Clinical Hospital Center Bezanijska Kosa Recruiting
Belgrade, Serbia, 11080
Clinical Center of Nis, Clinic for Cardiovascular Diseases Recruiting
Nis, Serbia, 18000
Spain
Complejo Hospitalario Universitario de Santiago de Compostela Recruiting
Santiago de Compostela, A Coruña, Spain, 15706
Hospital Universitario de Gran Canaria Dr. Negrin Recruiting
Las Palmas de Gran Canaria, Canarias, Spain, 35020
Hospital Universitario Marques de Valdecilla (HUMV) Recruiting
Santander, Cantabria, Spain, 39008
Hospital Virgen de la Salud (HVS) Recruiting
Toledo, Castile - La Mancha, Spain, 45004
Hospital Universitario Puerta de Hierro - Madrid Recruiting
Majadahonda, Madrid, Spain, 28222
Hospital Universitario Son Espases Recruiting
Palma de Mallorca, Mallorca, Spain, 7120
Hospital Universitario Vall d'hebron Recruiting
Barcelona, Spain, 8035
Hospital Clinic de Barcelona Recruiting
Barcelona, Spain, 8036
Hospital Universitario de Valladolid Recruiting
Valladolid, Spain, 47003
Ukraine
Dnipropetrovsk Regional Clinical Center of Cardiology and Cardiac Surger of Dnipropetrovsk Regional Council, Department of Cardiology Recruiting
Dnepropetrovsk, Ukraine, 49094
Dnipropetrovsk Regional Clinical Center of Cardiology and Cardiac Surgery of Dnipropetrovsk Regional Council, Department of Cardiology Recruiting
Dnepropetrovsk, Ukraine, 49094
Municipal Institution of health care "Kharkiv City Clinical Hospital №13", Pulmonology Department №1 Recruiting
Kharkiv, Ukraine, 61035
Government Institution "L.T.Malaya Therapy National Institute of the National Academy of Medical Sciences of Ukraine", Cardiopulmonology Department Recruiting
Kharkiv, Ukraine, 61039
National institute of phthisiology and pulmonology Recruiting
Kyiv, Ukraine, 03680
National Scientific Centre "M.D. STRAZHESKO INSTITUTE OF CARDIOLOGY, MAS OF UKRAINE" Recruiting
Kyiv, Ukraine, 03680
Lviv Regional Clinical Hospital, Department of Intesive Care #2 Recruiting
Lviv, Ukraine, 79010
United Kingdom
Freeman Hospital Recruiting
Newcastle Upon Tyne, Newcastle, United Kingdom, NE7 7DN
Golden Jubilee National Hospital Recruiting
Clydebank, West Dunbartonshire, United Kingdom, G81 4DY
Royal Free Hospital Recruiting
London, United Kingdom, NW3 3QG
Sponsors and Collaborators
Bellerophon Pulse Technologies
Worldwide Clinical Trials
Investigators
Study Director: Deborah Quinn, MD Bellerophon Therapuetics
  More Information

Responsible Party: Bellerophon Pulse Technologies
ClinicalTrials.gov Identifier: NCT02725372     History of Changes
Other Study ID Numbers: PULSE-PAH-004
First Submitted: January 19, 2016
First Posted: April 1, 2016
Last Update Posted: August 17, 2017
Last Verified: August 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Bellerophon ( Bellerophon Pulse Technologies ):
Pulmonary Arterial Hypertension
PAH
Inhaled Nitric Oxide
iNO
long term oxygen therapy
oxygen therapy

Additional relevant MeSH terms:
Hypertension
Familial Primary Pulmonary Hypertension
Vascular Diseases
Cardiovascular Diseases
Hypertension, Pulmonary
Lung Diseases
Respiratory Tract Diseases
Nitric Oxide
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Free Radical Scavengers
Antioxidants
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Endothelium-Dependent Relaxing Factors
Vasodilator Agents
Gasotransmitters
Protective Agents