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Pulmonary Arterial HypertensionPhase 3INOvation-1NCT02725372

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

A Phase 3 study testing Inhaled Nitric Oxide 75 mcg/kg IBW/hr in people with Pulmonary Arterial Hypertension, run by Bellerophon Pulse Technologies at 109 sites in 18 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
Search all trials

Trial summary

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 Read more about this study

Who is it for?
Ages 18 to 85 years
Conditions the study is for
Pulmonary Arterial Hypertension
What is being tested?
Inhaled Nitric Oxide 75 mcg/kg IBW/hr
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
207 participants
Where
109 sitesin 18 countries
Study dates
Apr 2016to Aug 2018
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 85 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Signed Informed Consent Form (and assent as appropriate) prior to the initiation of any study mandated procedures or assessments
  • 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
  • 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)
  • Subjects using oxygen therapy by nasal cannula for at least 4 weeks prior to Screening
  • PAH diagnosis confirmed by RHC within the previous 5 years, according to the following definitions:
  • PVR ≥ 400 dynes.sec.cm-5 (5 Wood units)
Show all 15Show fewer
  • 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
  • 6MWD ≥ 100 meters and ≤ 450 meters prior to randomization
  • 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
  • Age between 18 and 85 years (inclusive)
  • Willingness to use INOpulse delivery device for at least 12 hours per day
  • Willingness to continue on study drug until the subject has completed Week 18 assessments
  • 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.

Who cannot join

  • 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 7. PAH associated with significant venous or capillary involvement, known or suspected pulmonary veno-occlusive disease, or pulmonary capillary hemangiomatosis 8. Any subject with WHO PH Groups 2, 3, 4 or 5 9. Subjects with any of the following cardiac abnormalities:
  • Underlying cardiomyopathy or clinically significant aortic or mitral valve disease in the opinion of the investigator b. 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 c. Current symptomatic coronary artery disease, myocardial infarction within 1 year, or any coronary artery interventions within 6 months 10. 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) 11. 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 12. 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 13. 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 14. Any subject who develops or has developed a PCWP > 20 mmHg during acute vasodilator testing (AVT) 15. Systemic hypotension defined as SBP < 90 mmHg persistent at Screening after a period of rest 16. Moderate to severe hepatic impairment, i.e., Child-Pugh Class B or C 17. On dialysis 18. 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 19. Pregnant or breastfeeding females at Screening 20. Administered L-arginine within 1 month prior to Screening 21. Known concomitant life-threatening disease with a life expectancy less than 1 year 22. Atrial septostomy within 3 months preceding randomization 23. 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.
  • 24. Use of investigational drugs or devices within 1 month prior to Screening (other than acute vasodilator testing with iNO) 25. Any underlying medical or psychiatric condition that, in the opinion of the Investigator, makes the subject an unsuitable candidate for the study 26. Any subject who has been enrolled in any previous clinical study with inhaled NO administered through pulse delivery.

Trial locations and contacts

109 sites in 18 countries.

109 sites in 18 countries

United States37 sites

  • Albany Medical Center

    Albany, New York, 12208

  • Pulmonary and Critical Care of Atlanta

    Atlanta, Georgia, 30342

  • University of Colorado Denver

    Aurora, Colorado, 80045

  • Piedmont Healthcare Pulmonary and Critical Care Research

    Austell, Georgia, 30106

  • Cedars-Sinai Medical Center

    Beverly Hills, California, 90211

  • Brigham and Women's Hospital

    Boston, Massachusetts, 02115

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

    Brooklyn, New York, 11215

  • Medical University of South Carolina

    Charleston, South Carolina, 29425

  • Bluhm Cardiovascular Institute, Clinical Trials Unit

    Chicago, Illinois, 60611

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

    Cincinnati, Ohio, 45267-0564

  • Cleveland Clinic

    Cleveland, Ohio, 44195

  • MedTrial, LLC

    Columbia, South Carolina, 29204

  • The Ohio State University

    Columbus, Ohio, 43065

  • University of Texas Southwestern Medical Center of Dallas

    Dallas, Texas, 75390-8550

  • Pulmonary Disease Specialists, PA

    Kissimmee, Florida, 34741

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

    La Jolla, California, 92093

  • West Los Angeles VA Healthcare Center

    Los Angeles, California, 90073

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

    Louisville, Kentucky, 40202-1332

  • University of Wisconsin

    Madison, Wisconsin, 53792-1615

  • Wellstar Medical Group - Pulmonary Medicine

    Marietta, Georgia, 30060

  • Medical College of Wisconsin

    Milwaukee, Wisconsin, 53226

  • Winthrop University Hospital, Clinical Trials Center

    Mineola, New York, 11501

  • NYU Medical Center, Division Pulmonary, Critical Care and Sleep Medicine

    New York, New York, 10279

  • University of Nebraska Medical Center

    Omaha, Nebraska, 68198-5590

  • Central Florida Pulmonary Group, PA

    Orlando, Florida, 32803-5727

  • HeartCare Midwest

    Peoria, Illinois, 61616

  • Temple University Hospital

    Philadelphia, Pennsylvania, 19140

  • Arizona Pulmonary Specialists, Ltd

    Phoenix, Arizona, 85012

  • Allegheny Singer Research Institute

    Pittsburgh, Pennsylvania, 15212

  • Legacy Medical Group - Pulmonary Clinic

    Portland, Oregon, 97210

  • The Oregon Clinic, PC

    Portland, Oregon, 97220

  • Pulmonary Associates of Richmond

    Richmond, Virginia, 23229

  • University of California, Davis Medical Center

    Sacramento, California, 95817

  • Sioux Falls Cardiovascular

    Sioux Falls, South Dakota, 57108

  • Montefiore Medical Center - Weiler Division

    The Bronx, New York, 10461

  • University of Arizona Sarver Heart Center

    Tucson, Arizona, 85724-5046

  • Cleveland Clinic Florida

    Weston, Florida, 33331

Other trials in United States

Germany10 sites

  • Unfallkrankenhaus Berlin-Klinik für Innere Medizin/Kardiologie

    Berlin, 12683

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

    Dresden, Saxony, 01307

  • Helios Klinikum Erfurt

    Erfurt, Thuringia, 99089

  • "Universitätsklinikum Freiburg - Medizinische Universitätsklinik

    Freiburg im Breisgau, Baden-Wurttemberg, 79106

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

    Greifswald, Mecklenburg-Vorpommern, 17475

  • Medizinische Hochschule Hannover-Abteilung für Pneumologie

    Hanover, Lower Saxony, 30625

  • Thoraxklinik am Universitätsklinikum Heidelberg-Zentrum für Pulmonale Hypertension

    Heidelberg, Baden-Wurttemberg, 69126

  • Universitätsklinikum Leipzig-Dept. für Innere MedizinAbteilung für Pneumologie

    Leipzig, Saxony, 04103

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

    Regensburg, Bavaria, 93053

  • Waldburg-Zeil Kliniken - Fachkliniken Wangen Klinik für Pneumologie

    Wangen, Baden-Wurttemberg, 88239

Other trials in Germany

Spain9 sites

  • Hospital Universitario Vall d'hebron

    Barcelona, 8035

  • Hospital Clinic de Barcelona

    Barcelona, 8036

  • Hospital Universitario de Gran Canaria Dr. Negrin

    Las Palmas de Gran Canaria, Canary Islands, 35020

  • Hospital Universitario Puerta de Hierro - Madrid

    Majadahonda, Madrid, 28222

  • Hospital Universitario Son Espases

    Palma de Mallorca, Mallorca, 7120

  • Hospital Universitario Marques de Valdecilla (HUMV)

    Santander, Cantabria, 39008

  • Complejo Hospitalario Universitario de Santiago de Compostela

    Santiago de Compostela, A Coruña, 15706

  • Hospital Virgen de la Salud (HVS)

    Toledo, Castille-La Mancha, 45004

  • Hospital Universitario de Valladolid

    Valladolid, 47003

Other trials in Spain

Israel8 sites

  • Barzilai University Medical Center

    Ashkelon, 7830604

  • Soroka Medical Center

    Beersheba, 84101

  • Carmel Medical Center

    Haifa, 3436212

  • The Edith Wolfson Medical Center

    Holon, 58100

  • Hadassah University Medical Center

    Jerusalem

  • Meir Medical Center - Pulmonology Dept.

    Kfar Saba, 4428164

  • Rabin Medical Center

    Petah Tikva, 49100

  • Sheba Medical Center

    Ramat Gan, 5265601

Other trials in Israel

Australia7 sites

  • Royal Adelaide Hospital

    Adelaide, South Australia, 5000

  • St Vincent's Public Hospital

    Darlinghurst, New South Wales, 2010

  • Royal Hobart Hospital

    Hobart, Tasmania, 7000

  • Nepean Hospital

    Kingswood, New South Wales, 2747

  • Macquarie University Hospital

    Sydney, New South Wales, 2109

  • Concord Repatriation General Hospital

    Sydney, New South Wales, 2139

  • Princess Alexandra Hospital

    Woolloongabba, Queensland, 4102

Other trials in Australia

Ukraine6 sites

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

    Dnipro, 49094

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

    Kharkiv, 61035

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

    Kharkiv, 61039

  • National institute of phthisiology and pulmonology

    Kyiv, 03680

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

    Kyiv, 03680

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

    Lviv, 79010

Other trials in Ukraine

France5 sites

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

    Grenoble, Rhone, 38043

  • Hôpital Arnaud De Villeneuve - Service des Maladies Respiratoires

    Montpellier, 34295

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

    Nice, 06001

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

    Rouen, Normandy, 76031

  • Centre Hospitalier Universitaire de Saint Etienne

    Saint-Priest-en-Jarez, Rhone, 42270

Other trials in France

Serbia5 sites

  • Clinical Center of Serbia Department of Cardiology and Polyclinic

    Belgrade, 11000

  • Clinical Center of Serbia, Polyclinic, Pulomology Department

    Belgrade, 11000

  • Clinical-Hospital Center Zemun

    Belgrade, 11070

  • Clinical Hospital Center Bezanijska Kosa

    Belgrade, 11080

  • Clinical Center of Nis, Clinic for Cardiovascular Diseases

    Niš, 18000

Other trials in Serbia

Italy4 sites

  • Azienda Ospedaliera Papa Giovanni XXIII

    Bergamo, BG, 24129

  • Azienda Ospedaliera San Gerardo - Monza

    Monza, MI, 20900

  • Istituto Mediterraneo per i Trapianti e Terapie ad Alta Specializzazione

    Palermo, PA, 90127

  • A.O.U. Policlinico Umberto I- Università La Sapienza

    Roma, RM, 00161

Other trials in Italy

United Kingdom4 sites

  • Golden Jubilee National Hospital

    Clydebank, West Dunbartonshire, G81 4DY

  • Royal Free Hospital

    London, NW3 3QG

  • Royal Brompton Hospital

    London, SW3 6NP

  • Freeman Hospital

    Newcastle upon Tyne, Newcastle, NE7 7DN

Other trials in United Kingdom

Canada3 sites

  • Faculty of Medicine / Peter Lougheed Center / Respiratory Research

    Calgary, Alberta, T1Y 6J4

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

    London, Ontario, N6A 5W9

  • Toronto General Hospital, University Health Network

    Toronto, Ontario, M5G 2C4

Other trials in Canada

Portugal3 sites

  • Hospital Garcia de Orta

    Almada, Lisbon District, 2801-951

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

    Coimbra, Mondego, 3049

  • Centro Hospitalar de Lisboa Norte - Hospital de Santa Maria

    Lisbon, 1649-035

Other trials in Portugal

Austria2 sites

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

    Innsbruck, Tyrol, 6020

  • AKH-Vienna, Medical University of Vienna

    Vienna, 1090

Other trials in Austria

Belgium2 sites

  • Hopital Erasme - Service de Cardiologie

    Brussels, 1070

  • Universitaire Ziekenhuizen (UZ) Leuven - Gasthuisberg -

    Leuven, Brabant, 3000

Other trials in Belgium

Colombia1 site

  • Fundación Abood Shaio

    Bogotá, Bogota D.C.

Other trials in Colombia

Croatia1 site

  • University Hospital centre Zagreb

    Zagreb, 10000

Other trials in Croatia

Czechia1 site

  • Vseobecna Fakultni Nemocnice v Praze (VFN)

    Prague, Bohemia, 128 02

Other trials in Czechia

Netherlands1 site

  • Vrije Universiteit Medisch Centrum (VUMC)

    Amsterdam, 1081 HV

Other trials in Netherlands

About this study

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)

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

Read the 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)

Being tested
Inhaled Nitric Oxide 75 mcg/kg IBW/hr, Placebo
Keywords
Pulmonary Arterial Hypertension, PAH, Inhaled Nitric Oxide, iNO, long term oxygen therapy, oxygen therapy
Medical subject headings
Pulmonary Arterial Hypertension

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Inhaled Nitric Oxide 75 mcg/kg IBW/hrDrug

    Also called Inhaled Nitric Oxide, iNO

    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)

  • PlaceboDrug

    Also called Inhaled Nitric Oxide, iNO

    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

Study groups in NCT02725372
Study groupRoleWhat they receive
Inhaled Nitric Oxide 75mcg/KgIBW/HrExperimentalPart 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 (Open Label Treatment - All Subjects)
Receives: Drug: Inhaled Nitric Oxide 75 mcg/kg IBW/hr
PlaceboPlacebo comparatorPart 1: Placebo dose setting 15mcg/kg IBW/hr Run In Period / Placebo dose setting 75 mcg/kg IBW/hr treatment period
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in 6-minute Walk Distance (6MWD) From Baseline (Randomization) to End of Treatment Period (Week 18)

    The 6-minute walk distance test (6MWD) is a non-encouraged test performed in a 30 m long flat corridor, where the patient is instructed to walk as far as possible, back and forth around two cones, with the permission to slow down, rest, or stop if needed. All patients were required to complete two walks while on chronic oxygen therapy given at a standard rate during the test and throughout the study while using the investigational product (INOpulse device with nitric oxide or matching placebo). The average of two walks at Week 2 visit (2 weeks after Run-In) was used as the Baseline 6MWD.

    Measured: Change in 6MWD from Week 2 (2 weeks after randomization and run-in period) to Week 18 (end of blinded treatment period)

Secondary outcomes (2)

  1. Time (in Days) to First Clinical Worsening Event (TTCW)

    Clinical worsening was assessed continuously from Randomization to Week 18 (End of blinded treatment period). Clinical worsening events were defined as death (all causes), atrial septostomy, hospitalization due to worsening of pulmonary arterial hypertension (PAH), initiation of new pulmonary arterial hypertension treatment including endothelin receptor antagonists [ERAs], phosphodiesterase type-5 [PDE-5] inhibitors or prostanoids, an increase in existing treatment of 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%, a decrease of >15% from baseline or >30% compared with the last study related measurement in 6MWD or worsening of WHO Functional Class (e.g., from Class II to Class III or IV, OR Class III to Class IV). All worsening events were entered by the study sites into the eCRF.

    Measured: From Randomization to Week 18 (End of blinded treatment period)

  2. Number of Participants With an Improvement in World Health Organization Functional Class (WHO FC) Baseline (Randomization) to End of Treatment Period (Week 18)

    WHO FC (where Class I is defined as "No limitations in daily physical activities. No symptoms of dyspnea and with routine exertion" and Class IV is defined as "Inability to perform even minimal activities. Signs and symptoms of right heart failure may be present. Dyspnea present at rest") for PAH was taken at randomization (Week 0) for all participants and was assessed after blinded treatment (Week 18). The number of participants that had an improvement (lower functional class) as compared to baseline were measured.

    Measured: From Randomization to Week 18 (End of blinded treatment period)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Apr 2016 (estimated)
  2. Study startApr 2016
  3. Primary completionAug 2018
  4. Study completionAug 2018

Why it stopped: Trial stopped for futility

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
207 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02725372
Sponsor's protocol ID
PULSE-PAH-004
Acronym
INOvation-1
Status last verified
Jan 2023
First submitted
19 Jan 2016
Last updated
21 Feb 2023
Data monitoring committee
Yes
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Inhaled Nitric Oxide 75 mcg/kg IBW/hr in people with Pulmonary Arterial Hypertension, run by Bellerophon Pulse Technologies at 109 sites in 18 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 15 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 21 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 109 sites in United States, Germany, Spain, Israel, Australia and 13 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 25 Jan 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in 6-minute Walk Distance (6MWD) From Baseline (Randomization) to End of Treatment Period (Week 18) (time frame: Change in 6MWD from Week 2 (2 weeks after randomization and run-in period) to Week 18 (end of blinded treatment period)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02725372.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Feb 2023.

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