<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/NCT03785405</url>
  </required_header>
  <id_info>
    <org_study_id>CLCZ696B2319E1</org_study_id>
    <nct_id>NCT03785405</nct_id>
  </id_info>
  <brief_title>CLCZ696B2319E1 OL Extension Study to Evaluate Long-term Safety of Sacubitril/Valsartan in Pediatric Patients With HF</brief_title>
  <official_title>A Multicenter Study to Evaluate Long-term Safety and Tolerability of Open Label Sacubitril/Valsartan in Pediatric Patients With Heart Failure Due to Systemic Left Ventricle Systolic Dysfunction Who Have Completed Study CLCZ696B2319</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Novartis Pharmaceuticals</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Novartis</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 this study is to evaluate long-term safety and tolerability data in eligible&#xD;
      CLCZ696B2319 (PANORAMA-HF) patients receiving open-label sacubitril/valsartan.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">May 2, 2019</start_date>
  <completion_date type="Anticipated">December 29, 2023</completion_date>
  <primary_completion_date type="Anticipated">December 29, 2023</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>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Number of participants with Adverse Events (AEs) as a measure of safety and tolerability</measure>
    <time_frame>to end of study, up to 3 years</time_frame>
    <description>Safety. Assessments include: Adverse Events (AEs)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of participants with Serious Adverse Events (SAEs) as a measure of safety and tolerability</measure>
    <time_frame>to end of study, up to 3 years</time_frame>
    <description>Safety. Assessments include: Serious Adverse Events (SAEs)</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">216</enrollment>
  <condition>Heart Failure</condition>
  <arm_group>
    <arm_group_label>sacubitril/valsartan</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>single arm, open label sacubitril/valsartan</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>sacubitril/valsartan</intervention_name>
    <description>Target dose 3.1 mg/kg bid&#xD;
Formulations:&#xD;
Tablets (50, 100, 200 mg) Granules [12.5 mg (4 granules), 31.25 mg (10 granules), in capsules] Liquid (1 mg/ml, 4 mg/ml, prepared from tablets)</description>
    <arm_group_label>sacubitril/valsartan</arm_group_label>
    <other_name>LCZ696</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Signed informed consent&#xD;
&#xD;
          -  On study drug at PANORAMA-HF Part 2 EOS visit. Does not have any significant safety&#xD;
             issue&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Subject only participated in PANORAMA-HF Part 1 or was a SF in PANORAMA-HF or&#xD;
             permanently discontinued study drug in PANORMA-HF Part 2&#xD;
&#xD;
          -  Use of investigational drugs within 5 half-lives of enrollment or within 30 days&#xD;
             (longer duration); with the exception of PANORAMA-HF study drug (requires &gt;/=36-hour&#xD;
             washout before baseline visit)&#xD;
&#xD;
          -  History of hypersensitivity or allergy to study treatment, its excipients or drugs of&#xD;
             similar chemical class, ACEIs, ARBs, or NEP inhibitor and known/suspected&#xD;
             contraindications to sacubitril/valsartan&#xD;
&#xD;
          -  Renal vascular hypertension (including renal artery stenosis)&#xD;
&#xD;
          -  Significant renal estimated glomerular filtration rate disorder (eGFR calculated using&#xD;
             modified Schwartz formula &lt;30% mean GFR for age); hepatic disorder (serum aspartate&#xD;
             aminotransferase or alanine aminotransferase &gt; 3 times upper limit of normal);&#xD;
             gastrointestinal disorder or biliary disorder&#xD;
&#xD;
          -  History of angioedema&#xD;
&#xD;
          -  Parents or legal guardians of subject who do not give consent or allow the child to&#xD;
             give assent, or inability of patient or parents/legal guardians to follow instructions&#xD;
             or comply with follow-up procedures&#xD;
&#xD;
          -  Any medical condition(s) that may put the patient at risk in the investigator's&#xD;
             opinion or that the investigator deems unsuitable for the study&#xD;
&#xD;
          -  Other protocol defined inclusion/exclusion criteria may apply&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>1 Year</minimum_age>
    <maximum_age>18 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Novartis Pharmaceuticals</last_name>
    <role>Study Director</role>
    <affiliation>Novartis Pharmaceuticals</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Loma Linda</city>
        <state>California</state>
        <zip>92354</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Los Angeles</city>
        <state>California</state>
        <zip>90095</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Palo Alto</city>
        <state>California</state>
        <zip>94304</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Saint Petersburg</city>
        <state>Florida</state>
        <zip>33701</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Atlanta</city>
        <state>Georgia</state>
        <zip>30322</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Indianapolis</city>
        <state>Indiana</state>
        <zip>46202</zip>
        <country>United States</country>
      </address>
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  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02115</zip>
        <country>United States</country>
      </address>
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  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Ann Arbor</city>
        <state>Michigan</state>
        <zip>48109-5238</zip>
        <country>United States</country>
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  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Minneapolis</city>
        <state>Minnesota</state>
        <zip>55455</zip>
        <country>United States</country>
      </address>
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  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Rochester</city>
        <state>Minnesota</state>
        <zip>55905</zip>
        <country>United States</country>
      </address>
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  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Saint Louis</city>
        <state>Missouri</state>
        <zip>63110</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10032</zip>
        <country>United States</country>
      </address>
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  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Charlotte</city>
        <state>North Carolina</state>
        <zip>28203</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Philadelphia</city>
        <state>Pennsylvania</state>
        <zip>19104</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Pittsburgh</city>
        <state>Pennsylvania</state>
        <zip>15224</zip>
        <country>United States</country>
      </address>
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  <location>
    <facility>
      <name>Novartis Investigative Site</name>
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        <city>Ciudad de Salta</city>
        <state>Provincia De Salta</state>
        <zip>A4406BPF</zip>
        <country>Argentina</country>
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  <location>
    <facility>
      <name>Novartis Investigative Site</name>
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        <zip>6020</zip>
        <country>Austria</country>
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  <location>
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      <name>Novartis Investigative Site</name>
      <address>
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        <zip>1309</zip>
        <country>Bulgaria</country>
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    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Edmonton</city>
        <state>Alberta</state>
        <zip>T6G 1C9</zip>
        <country>Canada</country>
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  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Toronto</city>
        <state>Ontario</state>
        <zip>M5G 1X8</zip>
        <country>Canada</country>
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  <location>
    <facility>
      <name>Novartis Investigative Site</name>
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        <city>Zagreb</city>
        <zip>10000</zip>
        <country>Croatia</country>
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  <location>
    <facility>
      <name>Novartis Investigative Site</name>
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        <city>Praha 5</city>
        <zip>150 06</zip>
        <country>Czechia</country>
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  <location>
    <facility>
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        <zip>00290</zip>
        <country>Finland</country>
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  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Paris cedex 15</city>
        <zip>75015</zip>
        <country>France</country>
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  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Berlin</city>
        <zip>13353</zip>
        <country>Germany</country>
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  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Erlangen</city>
        <zip>91054</zip>
        <country>Germany</country>
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    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Freiburg</city>
        <zip>79106</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Heidelberg</city>
        <zip>69120</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Stuttgart</city>
        <zip>70174</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Budapest</city>
        <zip>H 1096</zip>
        <country>Hungary</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>New Delhi</city>
        <state>Delhi</state>
        <zip>110076</zip>
        <country>India</country>
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    </facility>
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  <location>
    <facility>
      <name>Novartis Investigative Site</name>
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        <city>Ahmedabad</city>
        <state>Gujarat</state>
        <zip>380 060</zip>
        <country>India</country>
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        <state>Kerala</state>
        <zip>682041</zip>
        <country>India</country>
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  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
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        <zip>110029</zip>
        <country>India</country>
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  <location>
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        <zip>84101</zip>
        <country>Israel</country>
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        <state>BG</state>
        <zip>24127</zip>
        <country>Italy</country>
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        <state>BO</state>
        <zip>40138</zip>
        <country>Italy</country>
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  <location>
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        <state>FI</state>
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        <country>Italy</country>
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      <address>
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        <state>MI</state>
        <zip>20162</zip>
        <country>Italy</country>
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        <state>RM</state>
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        <country>Italy</country>
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        <state>TO</state>
        <zip>10126</zip>
        <country>Italy</country>
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        <zip>80131</zip>
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  <location>
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        <state>Aichi</state>
        <zip>474 8710</zip>
        <country>Japan</country>
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        <state>Hokkaido</state>
        <zip>060 8648</zip>
        <country>Japan</country>
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      <name>Novartis Investigative Site</name>
      <address>
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        <state>Nagasaki</state>
        <zip>856-8562</zip>
        <country>Japan</country>
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    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Bunkyo ku</city>
        <state>Tokyo</state>
        <zip>113 8655</zip>
        <country>Japan</country>
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      <name>Novartis Investigative Site</name>
      <address>
        <city>Setagaya-ku</city>
        <state>Tokyo</state>
        <zip>157-8535</zip>
        <country>Japan</country>
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    <facility>
      <name>Novartis Investigative Site</name>
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        <city>Shinjuku ku</city>
        <state>Tokyo</state>
        <zip>162 8666</zip>
        <country>Japan</country>
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        <country>Japan</country>
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        <zip>51-124</zip>
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        <country>Portugal</country>
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        <country>Portugal</country>
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      <address>
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        <zip>125412</zip>
        <country>Russian Federation</country>
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  <location>
    <facility>
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      <address>
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        <zip>197341</zip>
        <country>Russian Federation</country>
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  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
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        <zip>119260</zip>
        <country>Singapore</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Singapore</city>
        <zip>229899</zip>
        <country>Singapore</country>
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    </facility>
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    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Soweto</city>
        <state>Gauteng</state>
        <zip>2013</zip>
        <country>South Africa</country>
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    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Cordoba</city>
        <state>Andalucia</state>
        <zip>14004</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Barcelona</city>
        <state>Cataluna</state>
        <zip>08950</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Barcelona</city>
        <state>Catalunya</state>
        <zip>08035</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Madrid</city>
        <zip>28009</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Madrid</city>
        <zip>28046</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Lausanne</city>
        <zip>1011</zip>
        <country>Switzerland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Tainan</city>
        <zip>70403</zip>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Taipei</city>
        <zip>10041</zip>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Bangkoknoi</city>
        <state>Bangkok</state>
        <zip>10700</zip>
        <country>Thailand</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Bangkok</city>
        <zip>10400</zip>
        <country>Thailand</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Ankara</city>
        <zip>06490</zip>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Izmir</city>
        <zip>35040</zip>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Konak-Izmir</city>
        <zip>35210</zip>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Argentina</country>
    <country>Austria</country>
    <country>Bulgaria</country>
    <country>Canada</country>
    <country>Croatia</country>
    <country>Czechia</country>
    <country>Finland</country>
    <country>France</country>
    <country>Germany</country>
    <country>Hungary</country>
    <country>India</country>
    <country>Israel</country>
    <country>Italy</country>
    <country>Japan</country>
    <country>Korea, Republic of</country>
    <country>Lebanon</country>
    <country>Poland</country>
    <country>Portugal</country>
    <country>Russian Federation</country>
    <country>Singapore</country>
    <country>South Africa</country>
    <country>Spain</country>
    <country>Switzerland</country>
    <country>Taiwan</country>
    <country>Thailand</country>
    <country>Turkey</country>
    <country>United States</country>
  </location_countries>
  <verification_date>August 2023</verification_date>
  <study_first_submitted>December 20, 2018</study_first_submitted>
  <study_first_submitted_qc>December 20, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 24, 2018</study_first_posted>
  <last_update_submitted>August 8, 2023</last_update_submitted>
  <last_update_submitted_qc>August 8, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">August 9, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>heart failure</keyword>
  <keyword>pediatric</keyword>
  <keyword>LCZ696</keyword>
  <keyword>sacubitril/valsartan</keyword>
  <keyword>open-label study</keyword>
  <keyword>angiotensin receptor neprilysin inhibitor</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Heart Failure</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Valsartan</mesh_term>
    <mesh_term>Sacubitril and valsartan sodium hydrate drug combination</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.&#xD;
This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com</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/NCT03785405
org study id: CLCZ696B2319E1
nct id: NCT03785405
lead sponsor: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
The purpose of this study is to evaluate long-term safety and tolerability data in eligible
      CLCZ696B2319 (PANORAMA-HF) patients receiving open-label sacubitril/valsartan.
allocation: N/A
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Number of participants with Adverse Events (AEs) as a measure of safety and tolerability
time frame: to end of study, up to 3 years
description: Safety. Assessments include: Adverse Events (AEs)
measure: Number of participants with Serious Adverse Events (SAEs) as a measure of safety and tolerability
time frame: to end of study, up to 3 years
description: Safety. Assessments include: Serious Adverse Events (SAEs)
arm group label: sacubitril/valsartan
arm group type: Experimental
description: single arm, open label sacubitril/valsartan
intervention type: Drug
intervention name: sacubitril/valsartan
description: Target dose 3.1 mg/kg bid
Formulations:
Tablets (50, 100, 200 mg) Granules [12.5 mg (4 granules), 31.25 mg (10 granules), in capsules] Liquid (1 mg/ml, 4 mg/ml, prepared from tablets)
arm group label: sacubitril/valsartan
other name: LCZ696
criteria: 
gender: All
minimum age: 1 Year
maximum age: 18 Years
healthy volunteers: No
last name: Novartis Pharmaceuticals
role: Study Director
affiliation: Novartis Pharmaceuticals
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country: Argentina
country: Austria
country: Bulgaria
country: Canada
country: Croatia
country: Czechia
country: Finland
country: France
country: Germany
country: Hungary
country: India
country: Israel
country: Italy
country: Japan
country: Korea, Republic of
country: Lebanon
country: Poland
country: Portugal
country: Russian Federation
country: Singapore
country: South Africa
country: Spain
country: Switzerland
country: Taiwan
country: Thailand
country: Turkey
country: United States
responsible party type: Sponsor
mesh term: Heart Failure
mesh term: Valsartan
mesh term: Sacubitril and valsartan sodium hydrate drug combination
sharing ipd: Yes
ipd description: Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.
This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com