<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT04417036</url>
  </required_header>
  <id_info>
    <org_study_id>19999</org_study_id>
    <secondary_id>2019-001078-27</secondary_id>
    <nct_id>NCT04417036</nct_id>
  </id_info>
  <brief_title>This Study Collects Information on the Safety of Inhaled Pegylated Adrenomedullin (PEG-ADM), How the Drug is Tolerated and How it Affects Patients Suffering From a Type of Lung Failure That Cause Fluid to Build up in the Lungs Making Breathing Difficult (ARDS)</brief_title>
  <acronym>SEAL</acronym>
  <official_title>Safety and Efficacy of Inhaled Pegylated Adrenomedullin (PEG-ADM) in Patients Suffering From Acute Respiratory Distress Syndrome (ARDS): a Double-blind, Randomized, Placebo-controlled, Multicenter Phase 2a/b Clinical Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Bayer</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Bayer</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      The study is composed of two parts. In part A of the study two active doses of inhaled&#xD;
      pegylated adrenomedullin (PEG-ADM) will be compared regarding safety and efficacy to a&#xD;
      substance that has no therapeutic effect (placebo) in order to find an optimal and safe of&#xD;
      the study drug. In part B of the study the highest dose that is considered safe and has&#xD;
      demonstrated efficacy will be taken forward to collect information how well patients&#xD;
      suffering from Acute Respiratory Distress Syndrome (ARDS) respond to treatment with inhaled&#xD;
      pegylated adrenomedullin (PEG-ADM) compared to treatment with placebo. ARDS is a type of lung&#xD;
      failure that cause fluid to build up in the lungs making breathing difficult or impossible.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Terminated (based on Part A results, Bayer decided to not continue investigating BAY 1097761&#xD;
    further in Part B; this was not due to any safety data for BAY 1097761)&#xD;
  </why_stopped>
  <start_date type="Actual">July 7, 2020</start_date>
  <completion_date type="Actual">December 28, 2022</completion_date>
  <primary_completion_date type="Actual">December 28, 2022</primary_completion_date>
  <phase>Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>VFS in Part B participants</measure>
    <time_frame>At Day 28</time_frame>
    <description>Ventilator-free survival (VFS, participants alive and not on invasive mechanical ventilation)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>CUI in Part A participants</measure>
    <time_frame>Up to 7 days</time_frame>
    <description>Clinical Utility Index (CUI) is a summary measure used to compare different treatments, the index score will range between 0 and 1.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>VFS in Part A participants</measure>
    <time_frame>At Day 28</time_frame>
    <description>Ventilator-free survival (VFS, participants alive and not on invasive mechanical ventilation)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>All-cause mortality in Part A and Part B participants</measure>
    <time_frame>At Day 28, Day 60 and Day 90</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Proportion of participants who still require invasive mechanical ventilation support in Part A and Part B participants</measure>
    <time_frame>At Day 28 and Day 60</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Ventilator-free days (VFDs) in Part A and Part B participants</measure>
    <time_frame>Within Day 28 and Day 60</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>VFS in Part A and Part B participants</measure>
    <time_frame>At Day 60</time_frame>
    <description>Ventilator-free survival (VFS, participants alive and not on invasive mechanical ventilation)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Integrated analysis on VFS invoving all participants from Part A and Part B</measure>
    <time_frame>At Day 28 and Day 60</time_frame>
    <description>Ventilator-free survival (VFS, participants alive and not on invasive mechanical ventilation)</description>
  </secondary_outcome>
  <number_of_arms>5</number_of_arms>
  <enrollment type="Actual">90</enrollment>
  <condition>Acute Respiratory Distress Syndrome</condition>
  <arm_group>
    <arm_group_label>Part A - Active Drug Dose 1</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants will receive Active Drug Dose 1 for a maximum of 14 days in study phase Part A</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Part A - Active Drug Dose 2</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants will receive Active Drug Dose 2 for a maximum of 14 days in study phase Part A</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Part A - Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Participants will receive Placebo for a maximum of 14 days in study phase Part A</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Part B - Active Drug Dose</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants will receive Active Drug 1 or 2 for a maximum of 14 days in study phase Part B</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Part B - Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Participants will receive Placebo for a maximum of 14 days in study phase Part B</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>BAY1097761 Active Dose 1</intervention_name>
    <description>Participants will receive a lower dose ADM by inhalation</description>
    <arm_group_label>Part A - Active Drug Dose 1</arm_group_label>
    <arm_group_label>Part B - Active Drug Dose</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Placebo to BAY1097761</intervention_name>
    <description>Participants will receive Placebo to BAY1097761 by inhalation</description>
    <arm_group_label>Part A - Placebo</arm_group_label>
    <arm_group_label>Part B - Placebo</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>BAY1097761 Active Dose 2</intervention_name>
    <description>Participants will receive a higher dose ADM by inhalation</description>
    <arm_group_label>Part A - Active Drug Dose 2</arm_group_label>
    <arm_group_label>Part B - Active Drug Dose</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  ≥18 years of age at the time of inclusion into study.&#xD;
&#xD;
          -  Invasively mechanically ventilated acute respiratory distress syndrome [ARDS] patients&#xD;
             (diagnosed according to Berlin definition of ARDS, including positive end-expiratory&#xD;
             pressure [PEEP] of ≥5 cm H2O, X-ray (or CT scan) indicative of ARDS: bilateral&#xD;
             opacities not fully explained by cardiac failure, fluid overload, lobar/lung collapse,&#xD;
             effusions or nodules).&#xD;
&#xD;
          -  Initial diagnosis of mild, moderate or severe ARDS prior to study inclusion, with&#xD;
             acute onset of ARDS within 1 week after suspected trigger factor of&#xD;
&#xD;
               -  Pneumonia&#xD;
&#xD;
               -  Aspiration&#xD;
&#xD;
               -  Sepsis&#xD;
&#xD;
               -  Pancreatitis&#xD;
&#xD;
          -  Prior to randomization, hypoxemia with PaO2:FiO2 ≤300 mmHg continuously observed for a&#xD;
             period of ≥4 hours (with values of ≥2 arterial blood gas [ABG] analyses during that&#xD;
             time, with the last value obtained timely (generally ≤3 hours) prior to&#xD;
             randomization), under ventilation with minimum PEEP ≥8 cm H2O.&#xD;
&#xD;
          -  Time from first meeting the last diagnostic ARDS criterion (Berlin criteria) to&#xD;
             randomization must be ≤48 hours.&#xD;
&#xD;
          -  For Study Part A: ARDS patients for whom measurements of extra-vascular lung water are&#xD;
             regarded as medically indicated by the treating physician, and these measurements are&#xD;
             planned as part of their clinical care, from Study Day 1 up to Study Day 7 (if then&#xD;
             still intubated).&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Any value of a PaO2:FiO2 ratio &gt;300 mmHg within a time interval of 4 hours before&#xD;
             randomization&#xD;
&#xD;
          -  Rescue therapy (e.g. inhalation of nitric oxide gas and/or inhalation of prostacyclin&#xD;
             analogues, or extra corporeal membrane oxygenation [ECMO] / extra corporeal CO2&#xD;
             removal [ECCO2R]) already initiated at screening and/or Study Day 1 (prior to first&#xD;
             dose of the study intervention)&#xD;
&#xD;
          -  Moribund participants not expected to survive 24 hours (clinical decision)&#xD;
&#xD;
          -  Expected duration of invasive mechanical ventilation less than 48 hours (clinical&#xD;
             decision)&#xD;
&#xD;
          -  History of co-morbidities requiring long-term/home oxygen use (e.g. severe chronic&#xD;
             obstructive pulmonary disease [COPD], pulmonary fibrosis) or non-invasive ventilation&#xD;
             (except for sleep apnea management), or making weaning per se improbable (e.g. ALS,&#xD;
             muscular dystrophy)&#xD;
&#xD;
          -  Smoke inhalation injury, extensive burns or trauma/head injury as concomitant&#xD;
             condition&#xD;
&#xD;
          -  History of pneumectomy, lung lobectomy or lung transplant&#xD;
&#xD;
          -  Diffuse alveolar hemorrhage from vasculitis&#xD;
&#xD;
          -  Current lung malignancy (incl. lung metastasis), or other malignancy requiring&#xD;
             chemotherapy or radiation within the last month&#xD;
&#xD;
          -  Chronic kidney disease with a history of renal replacement therapy (e.g. dialysis)&#xD;
&#xD;
          -  Chronic liver disease Child-Pugh Class C&#xD;
&#xD;
          -  Chronic heart failure NYHA IV&#xD;
&#xD;
          -  Known hypersensitivity to polyethyleneglycol (PEG, Macrogol)&#xD;
&#xD;
          -  Participation in other interventional studies involving pharmacological interventions,&#xD;
             or biological or cell therapy interventions&#xD;
&#xD;
          -  Diagnosis of COVID-19 pneumonia within 6 weeks prior to study inclusion. History of&#xD;
             SARS-CoV-2 infection (positive test based on nucleic acid amplification technology or&#xD;
             positive antigen test) without COVID-19 pneumonia does not exclude patients&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Medizinische Universität Innsbruck</name>
      <address>
        <city>Innsbruck</city>
        <state>Tirol</state>
        <zip>6020</zip>
        <country>Austria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Universitätsklinikum AKH Wien</name>
      <address>
        <city>Wien</city>
        <zip>1090</zip>
        <country>Austria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Fakultni nemocnice Kralovske Vinohrady</name>
      <address>
        <city>Praha 10</city>
        <zip>10034</zip>
        <country>Czechia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Fakultni nemocnice v Motole</name>
      <address>
        <city>Praha 5</city>
        <zip>150 06</zip>
        <country>Czechia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Masaryk Hospital Usti n/L</name>
      <address>
        <city>Usti nad Labem</city>
        <zip>401 13</zip>
        <country>Czechia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centre Hospitalier Universitaire - Angers</name>
      <address>
        <city>Angers Cedex 09</city>
        <zip>49933</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Center Hospitalier Michallon - Grenoble</name>
      <address>
        <city>La Tronche</city>
        <zip>38700</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hôpital du Nord - Marseille</name>
      <address>
        <city>Marseille Cedex 20</city>
        <zip>13915</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hôpital de la Pitié-Salpétrière</name>
      <address>
        <city>Paris</city>
        <zip>75013</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Cochin - Paris</name>
      <address>
        <city>Paris</city>
        <zip>75014</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hôpital Civil - Strasbourg</name>
      <address>
        <city>Strasbourg</city>
        <zip>67091</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Klinikum Oldenburg AöR</name>
      <address>
        <city>Oldenburg</city>
        <state>Niedersachsen</state>
        <zip>26133</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Klinikum der Stadt Köln gGmbH - Krankenhaus Merheim</name>
      <address>
        <city>Köln</city>
        <state>Nordrhein-Westfalen</state>
        <zip>51109</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Universitätsklinikum Schleswig-Holstein (UKSH)</name>
      <address>
        <city>Kiel</city>
        <state>Schleswig-Holstein</state>
        <zip>24105</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Istituto Clinico Humanitas - Humanitas Mirasole S.p.A.</name>
      <address>
        <city>Milano</city>
        <state>Lombardia</state>
        <zip>20089</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico</name>
      <address>
        <city>Milano</city>
        <state>Lombardia</state>
        <zip>20122</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>ASST Santi Paolo e Carlo</name>
      <address>
        <city>Milano</city>
        <state>Lombardia</state>
        <zip>20142</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Corporació Sanitària Parc Taulí</name>
      <address>
        <city>Sabadell</city>
        <state>Barcelona</state>
        <zip>08208</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ciutat Sanitaria i Universitaria de la Vall d'Hebron</name>
      <address>
        <city>Barcelona</city>
        <zip>08035</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital de la Santa Creu i de Sant Pau</name>
      <address>
        <city>Barcelona</city>
        <zip>08041</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University Hospital of Wales</name>
      <address>
        <city>Cardiff</city>
        <zip>CF14 4XW</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Guy's Hospital</name>
      <address>
        <city>London</city>
        <zip>SE1 9RT</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Austria</country>
    <country>Czechia</country>
    <country>France</country>
    <country>Germany</country>
    <country>Italy</country>
    <country>Spain</country>
    <country>United Kingdom</country>
  </location_countries>
  <removed_countries>
    <country>Belgium</country>
    <country>Canada</country>
    <country>Denmark</country>
    <country>Finland</country>
    <country>Greece</country>
    <country>Hungary</country>
    <country>Ireland</country>
    <country>Israel</country>
    <country>Korea, Republic of</country>
    <country>Netherlands</country>
    <country>Portugal</country>
    <country>Romania</country>
    <country>Russian Federation</country>
    <country>Slovakia</country>
    <country>Switzerland</country>
    <country>Taiwan</country>
  </removed_countries>
  <link>
    <url>https://clinicaltrials.bayer.com/</url>
    <description>Click here to find information for studies related to Bayer products. To find this study enter the ClinicalTrials.gov identifier (NCT) number or Bayer Study Identifier (ID) in the search field.</description>
  </link>
  <verification_date>March 2023</verification_date>
  <study_first_submitted>May 29, 2020</study_first_submitted>
  <study_first_submitted_qc>June 2, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 4, 2020</study_first_posted>
  <last_update_submitted>April 13, 2023</last_update_submitted>
  <last_update_submitted_qc>April 13, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">April 18, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Respiratory Distress Syndrome</mesh_term>
    <mesh_term>Respiratory Distress Syndrome, Newborn</mesh_term>
    <mesh_term>Acute Lung Injury</mesh_term>
    <mesh_term>Syndrome</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>Availability of this study's data will later be determined according to Bayer's commitment to the EFPIA/PhRMA &quot;Principles for responsible clinical trial data sharing&quot;. This pertains to scope, timepoint and process of data access. As such, Bayer commits to sharing upon request from qualified researchers patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the US and EU as necessary for conducting legitimate research. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014.&#xD;
Interested researchers can use www.vivli.org to request access to anonymized patient-level data and supporting documents from clinical studies to conduct research. Information on the Bayer criteria for listing studies and other relevant information is provided in the member section of the portal.</ipd_description>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT04417036
org study id: 19999
secondary id: 2019-001078-27
nct id: NCT04417036
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
is us export: No
The study is composed of two parts. In part A of the study two active doses of inhaled
      pegylated adrenomedullin (PEG-ADM) will be compared regarding safety and efficacy to a
      substance that has no therapeutic effect (placebo) in order to find an optimal and safe of
      the study drug. In part B of the study the highest dose that is considered safe and has
      demonstrated efficacy will be taken forward to collect information how well patients
      suffering from Acute Respiratory Distress Syndrome (ARDS) respond to treatment with inhaled
      pegylated adrenomedullin (PEG-ADM) compared to treatment with placebo. ARDS is a type of lung
      failure that cause fluid to build up in the lungs making breathing difficult or impossible.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: VFS in Part B participants
time frame: At Day 28
description: Ventilator-free survival (VFS, participants alive and not on invasive mechanical ventilation)
measure: CUI in Part A participants
time frame: Up to 7 days
description: Clinical Utility Index (CUI) is a summary measure used to compare different treatments, the index score will range between 0 and 1.
measure: VFS in Part A participants
time frame: At Day 28
description: Ventilator-free survival (VFS, participants alive and not on invasive mechanical ventilation)
measure: All-cause mortality in Part A and Part B participants
time frame: At Day 28, Day 60 and Day 90
measure: Proportion of participants who still require invasive mechanical ventilation support in Part A and Part B participants
time frame: At Day 28 and Day 60
measure: Ventilator-free days (VFDs) in Part A and Part B participants
time frame: Within Day 28 and Day 60
measure: VFS in Part A and Part B participants
time frame: At Day 60
description: Ventilator-free survival (VFS, participants alive and not on invasive mechanical ventilation)
measure: Integrated analysis on VFS invoving all participants from Part A and Part B
time frame: At Day 28 and Day 60
description: Ventilator-free survival (VFS, participants alive and not on invasive mechanical ventilation)
arm group label: Part A - Active Drug Dose 1
arm group type: Experimental
description: Participants will receive Active Drug Dose 1 for a maximum of 14 days in study phase Part A
arm group label: Part A - Active Drug Dose 2
arm group type: Experimental
description: Participants will receive Active Drug Dose 2 for a maximum of 14 days in study phase Part A
arm group label: Part A - Placebo
arm group type: Placebo Comparator
description: Participants will receive Placebo for a maximum of 14 days in study phase Part A
arm group label: Part B - Active Drug Dose
arm group type: Experimental
description: Participants will receive Active Drug 1 or 2 for a maximum of 14 days in study phase Part B
arm group label: Part B - Placebo
arm group type: Placebo Comparator
description: Participants will receive Placebo for a maximum of 14 days in study phase Part B
intervention type: Drug
intervention name: BAY1097761 Active Dose 1
description: Participants will receive a lower dose ADM by inhalation
arm group label: Part A - Active Drug Dose 1
arm group label: Part B - Active Drug Dose
intervention type: Other
intervention name: Placebo to BAY1097761
description: Participants will receive Placebo to BAY1097761 by inhalation
arm group label: Part A - Placebo
arm group label: Part B - Placebo
intervention type: Drug
intervention name: BAY1097761 Active Dose 2
description: Participants will receive a higher dose ADM by inhalation
arm group label: Part A - Active Drug Dose 2
arm group label: Part B - Active Drug Dose
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
facility: 
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facility: 
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facility: 
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facility: 
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facility: 
country: Austria
country: Czechia
country: France
country: Germany
country: Italy
country: Spain
country: United Kingdom
country: Belgium
country: Canada
country: Denmark
country: Finland
country: Greece
country: Hungary
country: Ireland
country: Israel
country: Korea, Republic of
country: Netherlands
country: Portugal
country: Romania
country: Russian Federation
country: Slovakia
country: Switzerland
country: Taiwan
url: https://clinicaltrials.bayer.com/
description: Click here to find information for studies related to Bayer products. To find this study enter the ClinicalTrials.gov identifier (NCT) number or Bayer Study Identifier (ID) in the search field.
responsible party type: Sponsor
mesh term: Respiratory Distress Syndrome
mesh term: Respiratory Distress Syndrome, Newborn
mesh term: Acute Lung Injury
mesh term: Syndrome
sharing ipd: No
ipd description: Availability of this study's data will later be determined according to Bayer's commitment to the EFPIA/PhRMA "Principles for responsible clinical trial data sharing". This pertains to scope, timepoint and process of data access. As such, Bayer commits to sharing upon request from qualified researchers patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the US and EU as necessary for conducting legitimate research. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014.
Interested researchers can use www.vivli.org to request access to anonymized patient-level data and supporting documents from clinical studies to conduct research. Information on the Bayer criteria for listing studies and other relevant information is provided in the member section of the portal.