<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/NCT04464525</url>
  </required_header>
  <id_info>
    <org_study_id>20190370</org_study_id>
    <nct_id>NCT04464525</nct_id>
  </id_info>
  <brief_title>Omecamtiv Mecarbil Post-trial Access Study</brief_title>
  <official_title>Omecamtiv Mecarbil Post-trial Access Protocol for Subjects Completing Study 20110203 GALACTIC-HF</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Cytokinetics</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Cytokinetics</source>
  <oversight_info>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The primary objective of this study is to provide access to omecamtiv mecarbil for&#xD;
      participants who have completed GALACTIC-HF 20110203.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This study was conducted by Amgen as the IND holder, with Cytokinetics as a collaborator. Due&#xD;
      to the termination of the collaboration agreement between Amgen and Cytokinetics in May 2021&#xD;
      and subsequent transfer of the omecamtiv mecarbil IND from Amgen to Cytokinetics,&#xD;
      Cytokinetics is now listed as the sponsor.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Withdrawn</overall_status>
  <why_stopped>
    Sponsor decision&#xD;
  </why_stopped>
  <start_date type="Anticipated">December 18, 2020</start_date>
  <completion_date type="Anticipated">November 27, 2026</completion_date>
  <primary_completion_date type="Anticipated">November 27, 2026</primary_completion_date>
  <phase>Phase 3</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Number of participants administered omecamtiv mecarbil during the treatment period</measure>
    <time_frame>Up to 252 weeks</time_frame>
    <description>Primary analysis is based on the exploratory outcome measure.</description>
  </primary_outcome>
  <other_outcome>
    <measure>Participant incidence of serious adverse events and treatment emergent adverse events</measure>
    <time_frame>Up to 252 weeks</time_frame>
    <description>Targeted adverse events are those which lead to temporary or permanent discontinuation of OM, adverse events that are possibly related to OM or study procedures, and all adverse events of myocardial infarction, myorcardial ischemia, and ventricular arrhythmia, irrespective of seriousness and relationship to OM.</description>
  </other_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">0</enrollment>
  <condition>Chronic Heart Failure With Reduced Ejection Fraction</condition>
  <arm_group>
    <arm_group_label>Omecamtiv mecarbil</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>All subjects will be assigned to OM</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Omecamtiv mecarbil</intervention_name>
    <description>Film-coated tablet administered orally.</description>
    <arm_group_label>Omecamtiv mecarbil</arm_group_label>
    <other_name>AMG 423</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Participant has provided GALACTIC-HF PTA informed consent prior to initiation of any&#xD;
             study specific activities/procedures.&#xD;
&#xD;
          -  Participant has completed GALACTIC-HF.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Investigational product was permanently discontinued during GALACTIC-HF due to&#xD;
             protocol-specified reason.&#xD;
&#xD;
          -  Female participant is pregnant or breastfeeding or planning to become pregnant or&#xD;
             breastfeed during treatment and for an additional 5 days after the last dose of&#xD;
             treatment.&#xD;
&#xD;
          -  Female participants of childbearing potential unwilling to use 2 acceptable methods of&#xD;
             effective contraception during treatment with OM and for an additional 5 days after&#xD;
             the last dose of treatment.&#xD;
&#xD;
          -  Female participants of childbearing potential with a positive pregnancy test assessed&#xD;
             on day 1 by a urine pregnancy test.&#xD;
&#xD;
          -  Participant has known sensitivity to any of the products or components to be&#xD;
             administered during dosing.&#xD;
&#xD;
          -  History or evidence of any clinically significant disorder, condition or disease that,&#xD;
             in the opinion of the investigator or Amgen physician, if consulted, would pose a risk&#xD;
             to participant safety or interfere with the study evaluation, procedures or&#xD;
             completion.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>85 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>MD</last_name>
    <role>Study Director</role>
    <affiliation>Amgen</affiliation>
  </overall_official>
  <link>
    <url>http://www.amgentrials.com</url>
    <description>AmgenTrials clinical trials website</description>
  </link>
  <verification_date>July 2021</verification_date>
  <study_first_submitted>July 6, 2020</study_first_submitted>
  <study_first_submitted_qc>July 6, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 9, 2020</study_first_posted>
  <last_update_submitted>July 25, 2021</last_update_submitted>
  <last_update_submitted_qc>July 25, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">July 30, 2021</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>Heart Failure</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request.</ipd_description>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
    <ipd_info_type>Informed Consent Form (ICF)</ipd_info_type>
    <ipd_info_type>Clinical Study Report (CSR)</ipd_info_type>
    <ipd_time_frame>Data sharing requests relating to this study will be considered beginning 18 months after the study has ended and either 1) the product and indication have been granted marketing authorization in both the US and Europe or 2) clinical development for the product and/or indication discontinues and the data will not be submitted to regulatory authorities. There is no end date for eligibility to submit a data sharing request for this study.</ipd_time_frame>
    <ipd_access_criteria>Qualified researchers may submit a request containing the research objectives, the Amgen product(s) and Amgen study/studies in scope, endpoints/outcomes of interest, statistical analysis plan, data requirements, publication plan, and qualifications of the researcher(s). In general, Amgen does not grant external requests for individual patient data for the purpose of re-evaluating safety and efficacy issues already addressed in the product labelling. Requests are reviewed by a committee of internal advisors. If not approved, a Data Sharing Independent Review Panel will arbitrate and make the final decision. Upon approval, information necessary to address the research question will be provided under the terms of a data sharing agreement. This may include anonymized individual patient data and/or available supporting documents, containing fragments of analysis code where provided in analysis specifications. Further details are available at the URL below.</ipd_access_criteria>
    <ipd_url>https://www.amgen.com/datasharing</ipd_url>
  </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/NCT04464525
org study id: 20190370
nct id: NCT04464525
lead sponsor: 
is fda regulated drug: Yes
is fda regulated device: No
The primary objective of this study is to provide access to omecamtiv mecarbil for
      participants who have completed GALACTIC-HF 20110203.
This study was conducted by Amgen as the IND holder, with Cytokinetics as a collaborator. Due
      to the termination of the collaboration agreement between Amgen and Cytokinetics in May 2021
      and subsequent transfer of the omecamtiv mecarbil IND from Amgen to Cytokinetics,
      Cytokinetics is now listed as the sponsor.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Number of participants administered omecamtiv mecarbil during the treatment period
time frame: Up to 252 weeks
description: Primary analysis is based on the exploratory outcome measure.
measure: Participant incidence of serious adverse events and treatment emergent adverse events
time frame: Up to 252 weeks
description: Targeted adverse events are those which lead to temporary or permanent discontinuation of OM, adverse events that are possibly related to OM or study procedures, and all adverse events of myocardial infarction, myorcardial ischemia, and ventricular arrhythmia, irrespective of seriousness and relationship to OM.
arm group label: Omecamtiv mecarbil
arm group type: Experimental
description: All subjects will be assigned to OM
intervention type: Drug
intervention name: Omecamtiv mecarbil
description: Film-coated tablet administered orally.
arm group label: Omecamtiv mecarbil
other name: AMG 423
criteria: 
gender: All
minimum age: 18 Years
maximum age: 85 Years
healthy volunteers: No
last name: MD
role: Study Director
affiliation: Amgen
url: http://www.amgentrials.com
description: AmgenTrials clinical trials website
responsible party type: Sponsor
mesh term: Heart Failure
sharing ipd: Yes
ipd description: De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request.
ipd info type: Study Protocol
ipd info type: Statistical Analysis Plan (SAP)
ipd info type: Informed Consent Form (ICF)
ipd info type: Clinical Study Report (CSR)
ipd time frame: Data sharing requests relating to this study will be considered beginning 18 months after the study has ended and either 1) the product and indication have been granted marketing authorization in both the US and Europe or 2) clinical development for the product and/or indication discontinues and the data will not be submitted to regulatory authorities. There is no end date for eligibility to submit a data sharing request for this study.
ipd access criteria: Qualified researchers may submit a request containing the research objectives, the Amgen product(s) and Amgen study/studies in scope, endpoints/outcomes of interest, statistical analysis plan, data requirements, publication plan, and qualifications of the researcher(s). In general, Amgen does not grant external requests for individual patient data for the purpose of re-evaluating safety and efficacy issues already addressed in the product labelling. Requests are reviewed by a committee of internal advisors. If not approved, a Data Sharing Independent Review Panel will arbitrate and make the final decision. Upon approval, information necessary to address the research question will be provided under the terms of a data sharing agreement. This may include anonymized individual patient data and/or available supporting documents, containing fragments of analysis code where provided in analysis specifications. Further details are available at the URL below.
ipd url: https://www.amgen.com/datasharing