<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/NCT04435782</url>
  </required_header>
  <id_info>
    <org_study_id>CR108753</org_study_id>
    <secondary_id>67896049PAH4005</secondary_id>
    <secondary_id>2019-004783-22</secondary_id>
    <nct_id>NCT04435782</nct_id>
  </id_info>
  <brief_title>A Study of Selexipag Assessing Right Ventricular Remodeling in Pulmonary Arterial Hypertension by Cardiac Magnetic Resonance Imaging</brief_title>
  <acronym>RESTORE</acronym>
  <official_title>A Prospective, Multicenter, Single-Arm, Open-Label, Phase 4 Study of the Effects of Selexipag on Right Ventricular Remodeling in Pulmonary Arterial Hypertension Assessed by Cardiac Magnetic Resonance Imaging</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Actelion</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Actelion</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of the study is to assess the effects of selexipag on right ventricular (RV)&#xD;
      function in participants with Pulmonary arterial hypertension (PAH).&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">July 7, 2021</start_date>
  <completion_date type="Anticipated">August 31, 2023</completion_date>
  <primary_completion_date type="Actual">July 28, 2023</primary_completion_date>
  <phase>Phase 4</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>Change from Baseline to Week 26 in Right Ventricular Stroke Volume (RVSV) Assessed by Pulmonary Artery Flow Magnetic Resonance Imaging (MRI)</measure>
    <time_frame>Baseline and week 26</time_frame>
    <description>Change from baseline to week 26 in RVSV in participants will be assessed by pulmonary artery flow MRI.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change from Baseline to Week 26 in RV End-Diastolic Volume (RVEDV) Assessed by MRI</measure>
    <time_frame>Baseline and week 26</time_frame>
    <description>Change from baseline to week 26 in RVEDV will be assessed by MRI.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from Baseline to Week 26 in RV End-Systolic Volume (RVESV) Assessed by MRI</measure>
    <time_frame>Baseline and week 26</time_frame>
    <description>Change from baseline to week 26 in RVESV will be assessed by MRI.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from Baseline to Week 26 in RV Ejection Fraction (RVEF) Assessed by MRI</measure>
    <time_frame>Baseline and week 26</time_frame>
    <description>Change from baseline to week 26 in RVEF will be assessed by MRI.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from Baseline to Week 26 in RV Mass Assessed by MRI</measure>
    <time_frame>Baseline and week 26</time_frame>
    <description>Change from baseline to week 26 in RV mass will be assessed by MRI.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from Baseline to Week 26 RV Global Longitudinal Strain (RVGLS) Assessed by MRI</measure>
    <time_frame>Baseline and week 26</time_frame>
    <description>Change from baseline to week 26 RVGLS will be assessed by MRI.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change of Baseline to Week 26 in World Health Organization Functional Class (WHO FC)</measure>
    <time_frame>Baseline and week 26</time_frame>
    <description>Change of baseline to week 26 in WHO FC in participants will be assessed.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change form Baseline to Week 26 in N-Terminal-Pro-Hormone Brain Natriuretic Peptide (NT-proBNP)</measure>
    <time_frame>Baseline and week 26</time_frame>
    <description>Change from baseline to week 26 NT-proBNP in participants will be assessed.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from Baseline to Week 26 in 6-Minute Walk Distance (6MWD)</measure>
    <time_frame>Baseline and week 26</time_frame>
    <description>Change from baseline to week 26 in 6MWD in participants will be assessed.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants with Treatment-Emergent Adverse Events (TEAEs)</measure>
    <time_frame>Up to 56 weeks</time_frame>
    <description>An AE is any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with the intervention. TEAE is any AE from first dose up to 3 days after end of study intervention.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants with Serious Adverse Events (SAEs)</measure>
    <time_frame>Up to 60 weeks</time_frame>
    <description>A serious adverse event (SAE) is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants with AEs Leading to Premature Discontinuation of Selexipag</measure>
    <time_frame>Up to 52 weeks</time_frame>
    <description>Number of participants with AEs leading to premature discontinuation of study drug Selexipag will be reported.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants with AEs of Special Interest</measure>
    <time_frame>Up to 60 weeks</time_frame>
    <description>Number of participants with AEs of special interest will be reported.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants with Treatment-Emergent Marked Laboratory Abnormalities</measure>
    <time_frame>Up to 56 weeks</time_frame>
    <description>Number of participants with treatment-emergent marked laboratory abnormalities will be reported.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from Baseline to Week 26 in Number of Non-Invasive Low-Risk Criteria Variable</measure>
    <time_frame>Baseline to week 26</time_frame>
    <description>Change from baseline to Week 26 in number of non-invasive low-risk criteria among the following 8 variables: Absence of clinical signs of right heart failure; Absence of symptoms progression; Absence of syncope; World Health Organization functional class (WHO FC) I-II; 6-minute walking distance (6MWD) greater than (&gt;) 440 meters (m); N-terminal-pro-hormone brain natriuretic peptide (NT-proBNP) less than (&lt;) 300 nanogram per liters (ng/L); Right atrial (RA) area &lt;18 centimeter square (cm^2), as determined by echocardiography (Echo) and Absence of pericardial effusion, as determined by Echo will be assessed.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">9</enrollment>
  <condition>Pulmonary Arterial Hypertension</condition>
  <arm_group>
    <arm_group_label>JNJ-67896049</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants will receive JNJ-67896049 tablets at a starting dose of 200 mcg on Day 1. Dose will be up-titrated from Day 1 to the end of Week 12 (Day 84) to determine individual maintenance dose (IMD). Then, participants will receive JNJ-67896049 tablets at their IMD from Week 13 to Week 52.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>JNJ-67896049</intervention_name>
    <description>Participants will receive tablets at a starting dose of 200 mcg on Day 1. Dose will be up-titrated from Day 1 to the end of Week 12 (Day 84) to determine individual maintenance dose (IMD). Then, participants will receive JNJ-67896049 tablets at their IMD from Week 13 to Week 52.</description>
    <arm_group_label>JNJ-67896049</arm_group_label>
    <other_name>Selexipag</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  World health organization functional class (WHO FC) II or III. Enrollment will be&#xD;
             stratified by WHO FC II or III. Proportion of participants with WHO FC II and WHO FC&#xD;
             III are expected to be approximately 40 percent (%) and 60%, respectively&#xD;
&#xD;
          -  Pulmonary arterial hypertension (PAH) etiology belonging to one of the following&#xD;
             groups according to 6th world symposium of pulmonary hypertension (WSPH)&#xD;
             classification: a) Idiopathic PAH, b) Heritable PAH, c) Drugs or toxins induced d) PAH&#xD;
             associated with connective tissue disease, e) PAH associated with congenital heart&#xD;
             disease, with simple systemic-to-pulmonary shunt at least 1 year after surgical repair&#xD;
&#xD;
          -  Patients already receiving PAH-specific oral mono or dual therapy (that is,&#xD;
             phosphodiesterase type 5 inhibitors [PDE-5i] or soluble guanylate cyclase stimulators&#xD;
             [sGCs] and/or endothelin receptor antagonist [ERA]) or patients who are not candidates&#xD;
             for these therapies&#xD;
&#xD;
          -  N-terminal-pro-hormone brain natriuretic peptide (NT-proBNP) greater than or equal to&#xD;
             (&gt;=) 300 nanograms per liter (ng/L) (greater than or equal to [&gt;=] 300 picograms per&#xD;
             milliliter [pg/mL]; &gt;=35.5 picomoles per liter [pmol/L]) at screening&#xD;
&#xD;
          -  Women of childbearing potential must meet the following criteria: a) Have a negative&#xD;
             serum pregnancy test during screening and a negative urine pregnancy test on Day 1, b)&#xD;
             Agree to use acceptable methods of contraception from Day 1 to at least 30 days after&#xD;
             study intervention discontinuation, c) If only using hormonal contraception, have used&#xD;
             it for at least 1 month (30 days) before Day 1, and d) Agree to perform monthly&#xD;
             pregnancy tests to at least 30 days after study intervention discontinuation&#xD;
&#xD;
          -  6-minute walking distance (6MWD) &gt;=150 meter (m) during screening period&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Prior use of Prostacyclin (IP)-receptor agonist, prostacyclin, or prostacyclin analog.&#xD;
             Use of such treatments for vasoreactivity testing is not exclusionary; intermittent&#xD;
             use of such treatments for digital ulcers or Raynaud's phenomenon is not exclusionary&#xD;
             if stopped &gt; 6 months (180 days) prior to Day 1&#xD;
&#xD;
          -  Treatment with strong inhibitors of CYP2C8 (example, gemfibrozil) within 4 weeks (28&#xD;
             days) prior to Day 1&#xD;
&#xD;
          -  Treatment with another investigational drug planned or taken within 12 weeks (84 days)&#xD;
             prior to Day 1&#xD;
&#xD;
          -  Severe coronary heart disease or unstable angina&#xD;
&#xD;
          -  Cerebrovascular events (example, transient ischemic attack, stroke) within 3 months&#xD;
             (90 days) prior to Day 1&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>64 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Actelion Clinical Trial</last_name>
    <role>Study Director</role>
    <affiliation>Actelion</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University Of California San Diego</name>
      <address>
        <city>La Jolla</city>
        <state>California</state>
        <zip>92093</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>AnMed Health</name>
      <address>
        <city>Anderson</city>
        <state>South Carolina</state>
        <zip>29621</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>UT Southwestern</name>
      <address>
        <city>Dallas</city>
        <state>Texas</state>
        <zip>75231</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Italiano de Buenos Aires</name>
      <address>
        <city>Caba</city>
        <zip>1199ABB</zip>
        <country>Argentina</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sanatorio Ramon Cereijo</name>
      <address>
        <city>Caba</city>
        <zip>C1048AAN</zip>
        <country>Argentina</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Instituto Cardiovascular de Buenos Aires</name>
      <address>
        <city>Ciudad Autonoma Buenos Aires</city>
        <zip>1428</zip>
        <country>Argentina</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Associacao Hospitalar Moinhos de Vento</name>
      <address>
        <city>Porto Alegre</city>
        <zip>90035-001</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Irmandade Santa Casa de Misericordia de Porto Alegre</name>
      <address>
        <city>Porto Alegre</city>
        <zip>90035-074</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Das Clinicas Da Faculdade De Medicina Da USP</name>
      <address>
        <city>Sao Paulo</city>
        <zip>05403-000</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>SPDM - Associacao Paulista para o Desenvolvimento da Medicina - Hospital Sao Paulo</name>
      <address>
        <city>São Paulo</city>
        <zip>04024-002</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHU Grenoble</name>
      <address>
        <city>La Tronche</city>
        <zip>38700</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>DRK Kliniken Westend</name>
      <address>
        <city>Berlin</city>
        <zip>14050</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Universitatsklinikum Bonn</name>
      <address>
        <city>Bonn</city>
        <zip>53127</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Universitätsmedizin der Johannes Gutenberg-Universität Mainz</name>
      <address>
        <city>Mainz</city>
        <zip>55131</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Grantham Hospital</name>
      <address>
        <city>Hong Kong</city>
        <country>Hong Kong</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Queen Mary Hospital, University of Hong Kong</name>
      <address>
        <city>Hong Kong</city>
        <country>Hong Kong</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hadassah Medical Center</name>
      <address>
        <city>Jerusalem</city>
        <country>Israel</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Rabin Medical Center, Beilinson Campus</name>
      <address>
        <city>Petah Tikva</city>
        <zip>4941492</zip>
        <country>Israel</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Chungnam National University Hospital</name>
      <address>
        <city>Daejeon</city>
        <zip>35015</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Gachon University Gil Medical Center</name>
      <address>
        <city>Incheon</city>
        <zip>21565</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Seoul National University Hospital</name>
      <address>
        <city>Seoul</city>
        <zip>03080</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Asan Medical Center</name>
      <address>
        <city>Seoul</city>
        <zip>05505</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Samsung Medical Center</name>
      <address>
        <city>Seoul</city>
        <zip>06351</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Institut Jantung Negara</name>
      <address>
        <city>Kuala Lumpur</city>
        <zip>50400</zip>
        <country>Malaysia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>VUMC Amsterdam</name>
      <address>
        <city>Amsterdam</city>
        <zip>1081 HV</zip>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Radboud Umcn</name>
      <address>
        <city>Nijmegen</city>
        <zip>6525 GA</zip>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>National Medical Research Center of Cardiology of MoH of Russian Federation</name>
      <address>
        <city>Moscow</city>
        <zip>121552</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Federal State Budgetary Institution</name>
      <address>
        <city>St Petersburg</city>
        <zip>197341</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>King Faisal Specialist Hospital &amp; Research Center</name>
      <address>
        <city>Riyadh</city>
        <zip>12713</zip>
        <country>Saudi Arabia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>National Heart Centre (NHC) Singapore</name>
      <address>
        <city>Singapore</city>
        <zip>169609</zip>
        <country>Singapore</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Tan Tock Seng Hospital</name>
      <address>
        <city>Singapore</city>
        <zip>308433</zip>
        <country>Singapore</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Cleveland Clinic Abu Dhabi</name>
      <address>
        <city>Abu Dhabi</city>
        <zip>112412</zip>
        <country>United Arab Emirates</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Golden Jubilee National Hospital</name>
      <address>
        <city>Glasgow</city>
        <zip>G81 4HX</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Royal Free Hospital</name>
      <address>
        <city>Hampstead</city>
        <zip>NW3 2QG</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sheffield Teaching Hospitals NHS Foundation Trust Royal Hallamshire Hospital</name>
      <address>
        <city>Sheffield</city>
        <zip>S10 2RX</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Argentina</country>
    <country>Brazil</country>
    <country>France</country>
    <country>Germany</country>
    <country>Hong Kong</country>
    <country>Israel</country>
    <country>Korea, Republic of</country>
    <country>Malaysia</country>
    <country>Netherlands</country>
    <country>Russian Federation</country>
    <country>Saudi Arabia</country>
    <country>Singapore</country>
    <country>United Arab Emirates</country>
    <country>United Kingdom</country>
    <country>United States</country>
  </location_countries>
  <removed_countries>
    <country>China</country>
    <country>Italy</country>
  </removed_countries>
  <verification_date>August 2023</verification_date>
  <study_first_submitted>June 15, 2020</study_first_submitted>
  <study_first_submitted_qc>June 15, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 17, 2020</study_first_posted>
  <last_update_submitted>August 15, 2023</last_update_submitted>
  <last_update_submitted_qc>August 15, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">August 16, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Right ventricle</keyword>
  <keyword>Reverse remodeling</keyword>
  <keyword>Magnetic resonance Imaging</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Pulmonary Arterial Hypertension</mesh_term>
    <mesh_term>Familial Primary Pulmonary Hypertension</mesh_term>
    <mesh_term>Hypertension</mesh_term>
    <mesh_term>Ventricular Remodeling</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Selexipag</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>The data sharing policy of the Janssen Pharmaceutical Companies of Johnson &amp; Johnson is available at www.janssen.com/clinical-trials/transparency.&#xD;
As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu.</ipd_description>
    <ipd_url>https://www.janssen.com/clinical-trials/transparency</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/NCT04435782
org study id: CR108753
secondary id: 67896049PAH4005
secondary id: 2019-004783-22
nct id: NCT04435782
lead sponsor: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
The purpose of the study is to assess the effects of selexipag on right ventricular (RV)
      function in participants with Pulmonary arterial hypertension (PAH).
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Change from Baseline to Week 26 in Right Ventricular Stroke Volume (RVSV) Assessed by Pulmonary Artery Flow Magnetic Resonance Imaging (MRI)
time frame: Baseline and week 26
description: Change from baseline to week 26 in RVSV in participants will be assessed by pulmonary artery flow MRI.
measure: Change from Baseline to Week 26 in RV End-Diastolic Volume (RVEDV) Assessed by MRI
time frame: Baseline and week 26
description: Change from baseline to week 26 in RVEDV will be assessed by MRI.
measure: Change from Baseline to Week 26 in RV End-Systolic Volume (RVESV) Assessed by MRI
time frame: Baseline and week 26
description: Change from baseline to week 26 in RVESV will be assessed by MRI.
measure: Change from Baseline to Week 26 in RV Ejection Fraction (RVEF) Assessed by MRI
time frame: Baseline and week 26
description: Change from baseline to week 26 in RVEF will be assessed by MRI.
measure: Change from Baseline to Week 26 in RV Mass Assessed by MRI
time frame: Baseline and week 26
description: Change from baseline to week 26 in RV mass will be assessed by MRI.
measure: Change from Baseline to Week 26 RV Global Longitudinal Strain (RVGLS) Assessed by MRI
time frame: Baseline and week 26
description: Change from baseline to week 26 RVGLS will be assessed by MRI.
measure: Change of Baseline to Week 26 in World Health Organization Functional Class (WHO FC)
time frame: Baseline and week 26
description: Change of baseline to week 26 in WHO FC in participants will be assessed.
measure: Change form Baseline to Week 26 in N-Terminal-Pro-Hormone Brain Natriuretic Peptide (NT-proBNP)
time frame: Baseline and week 26
description: Change from baseline to week 26 NT-proBNP in participants will be assessed.
measure: Change from Baseline to Week 26 in 6-Minute Walk Distance (6MWD)
time frame: Baseline and week 26
description: Change from baseline to week 26 in 6MWD in participants will be assessed.
measure: Number of Participants with Treatment-Emergent Adverse Events (TEAEs)
time frame: Up to 56 weeks
description: An AE is any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with the intervention. TEAE is any AE from first dose up to 3 days after end of study intervention.
measure: Number of Participants with Serious Adverse Events (SAEs)
time frame: Up to 60 weeks
description: A serious adverse event (SAE) is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.
measure: Number of Participants with AEs Leading to Premature Discontinuation of Selexipag
time frame: Up to 52 weeks
description: Number of participants with AEs leading to premature discontinuation of study drug Selexipag will be reported.
measure: Number of Participants with AEs of Special Interest
time frame: Up to 60 weeks
description: Number of participants with AEs of special interest will be reported.
measure: Number of Participants with Treatment-Emergent Marked Laboratory Abnormalities
time frame: Up to 56 weeks
description: Number of participants with treatment-emergent marked laboratory abnormalities will be reported.
measure: Change from Baseline to Week 26 in Number of Non-Invasive Low-Risk Criteria Variable
time frame: Baseline to week 26
description: Change from baseline to Week 26 in number of non-invasive low-risk criteria among the following 8 variables: Absence of clinical signs of right heart failure; Absence of symptoms progression; Absence of syncope; World Health Organization functional class (WHO FC) I-II; 6-minute walking distance (6MWD) greater than (>) 440 meters (m); N-terminal-pro-hormone brain natriuretic peptide (NT-proBNP) less than (<) 300 nanogram per liters (ng/L); Right atrial (RA) area <18 centimeter square (cm^2), as determined by echocardiography (Echo) and Absence of pericardial effusion, as determined by Echo will be assessed.
arm group label: JNJ-67896049
arm group type: Experimental
description: Participants will receive JNJ-67896049 tablets at a starting dose of 200 mcg on Day 1. Dose will be up-titrated from Day 1 to the end of Week 12 (Day 84) to determine individual maintenance dose (IMD). Then, participants will receive JNJ-67896049 tablets at their IMD from Week 13 to Week 52.
intervention type: Drug
intervention name: JNJ-67896049
description: Participants will receive tablets at a starting dose of 200 mcg on Day 1. Dose will be up-titrated from Day 1 to the end of Week 12 (Day 84) to determine individual maintenance dose (IMD). Then, participants will receive JNJ-67896049 tablets at their IMD from Week 13 to Week 52.
arm group label: JNJ-67896049
other name: Selexipag
criteria: 
gender: All
minimum age: 18 Years
maximum age: 64 Years
healthy volunteers: No
last name: Actelion Clinical Trial
role: Study Director
affiliation: Actelion
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country: Argentina
country: Brazil
country: France
country: Germany
country: Hong Kong
country: Israel
country: Korea, Republic of
country: Malaysia
country: Netherlands
country: Russian Federation
country: Saudi Arabia
country: Singapore
country: United Arab Emirates
country: United Kingdom
country: United States
country: China
country: Italy
responsible party type: Sponsor
mesh term: Pulmonary Arterial Hypertension
mesh term: Familial Primary Pulmonary Hypertension
mesh term: Hypertension
mesh term: Ventricular Remodeling
mesh term: Selexipag
sharing ipd: Yes
ipd description: The data sharing policy of the Janssen Pharmaceutical Companies of Johnson & Johnson is available at www.janssen.com/clinical-trials/transparency.
As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu.
ipd url: https://www.janssen.com/clinical-trials/transparency