xml: <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/NCT05976230</url>
    </required_header>
    <id_info>
      <org_study_id>CLCZ696A1402</org_study_id>
      <nct_id>NCT05976230</nct_id>
    </id_info>
    <brief_title>Special Drug Use Surveillance of Entresto Tablets (Hypertension)</brief_title>
    <acronym>ENLIGHT</acronym>
    <official_title>Special Drug Use Surveillance of Entresto Tablets (Hypertension, CLCZ696A1402): ENLIGHT</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>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        This is a single arm, multicenter, observational study to evaluate the safety and efficacy of&#xD;
        Entresto Tablets during the first 52 weeks of treatment in Japanese patients with&#xD;
        hypertension.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        This study is a special drug use surveillance to collect information on the safety&#xD;
        specifications under the actual clinical practice of Entresto Tablets in patients with&#xD;
        hypertension in Japan to confirm the occurrence and timing of onset of events related to the&#xD;
        safety specifications and investigate their risk factors.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">September 1, 2023</start_date>
    <completion_date type="Anticipated">September 30, 2025</completion_date>
    <primary_completion_date type="Anticipated">September 30, 2025</primary_completion_date>
    <study_type>Observational</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <observational_model>Cohort</observational_model>
      <time_perspective>Prospective</time_perspective>
    </study_design_info>
    <primary_outcome>
      <measure>Percentage of patients with hypotension, hyperkalemia, and renal impairment/failure</measure>
      <time_frame>Up to 52 weeks</time_frame>
      <description>To investigate the safety of 52 weeks of treatment with Entresto in patients with hypertension in a real-world setting. In particular, the occurrence status of hypotension, hyperkalemia, and renal impairment/renal failure</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Percentage of patients with hypotension, hyperkalemia, and renal impairment/failure by risk factor</measure>
      <time_frame>Up to 52 weeks</time_frame>
      <description>To identify risk factors associated with the development of hypotension, hyperkalemia, and renal impairment/failure</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Odds ratio (OR) for each risk factor of hypotension, hyperkalemia, and renal impairment/failure</measure>
      <time_frame>Up to 52 weeks</time_frame>
      <description>To identify risk factors associated with the development of hypotension, hyperkalemia, and renal impairment/failure</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change from baseline in sitting systolic blood pressure (sSBP) and sitting diastolic blood pressure (sDBP) over time</measure>
      <time_frame>Up to 52 weeks</time_frame>
      <description>To evaluate the efficacy of 52 weeks of treatment with Entresto in a real-world setting</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Percentage of patients who achieved blood pressure control at each evaluation time point</measure>
      <time_frame>Up to 52 weeks</time_frame>
      <description>To evaluate the efficacy of 52 weeks of treatment with Entresto in a real-world setting</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Percentage of patients who achieved improvement in sSBP and sDBP at each evaluation time point</measure>
      <time_frame>Up to 52 weeks</time_frame>
      <description>To evaluate the efficacy of 52 weeks of treatment with Entresto in a real-world setting</description>
    </secondary_outcome>
    <number_of_groups>1</number_of_groups>
    <enrollment type="Anticipated">1000</enrollment>
    <condition>Hypertension</condition>
    <arm_group>
      <arm_group_label>Entresto</arm_group_label>
      <description>Patients administered Entresto by prescription</description>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Entresto</intervention_name>
      <description>There is no treatment allocation. Patients administered Entresto by prescription that have started before inclusion of the patient into the study will be enrolled.</description>
      <arm_group_label>Entresto</arm_group_label>
      <other_name>Entresto Tablets</other_name>
    </intervention>
    <eligibility>
      <study_pop>
        <textblock>
          Japanese patients with hypertension using Entresto&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            1. Patients who have given written consent to participate in this study before the start&#xD;
               of treatment with Entresto&#xD;
  &#xD;
            2. Patients who used Entresto for the first time for the indication of hypertension&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            1. Patients who have received a formulation containing the same ingredient as Entresto&#xD;
               (including investigational product or post-marketing clinical study drug)&#xD;
  &#xD;
            2. The following patients for whom administration of Entresto is contraindicated in the&#xD;
               package insert:&#xD;
  &#xD;
                 -  Patients with a history of hypersensitivity to any of the ingredients of Entresto&#xD;
  &#xD;
                 -  Patients who are receiving angiotensin-converting enzyme inhibitors (alacepril,&#xD;
                    imidapril hydrochloride, enalapril maleate, captopril, quinapril hydrochloride,&#xD;
                    cilazapril hydrate, temocapril hydrochloride, delapril hydrochloride,&#xD;
                    trandolapril, benazepril hydrochloride, perindopril erbumine, and lisinopril&#xD;
                    hydrate) or who discontinued these drugs within 36 hours.&#xD;
  &#xD;
                 -  Patients with a history of angioedema (angioedema due to angiotensin II receptor&#xD;
                    antagonists or angiotensin converting enzyme inhibitors, hereditary angioedema,&#xD;
                    acquired angioedema, idiopathic angioedema, etc.)&#xD;
  &#xD;
                 -  Patients with diabetes mellitus who are receiving aliskiren fumarate&#xD;
  &#xD;
                 -  Patients with severe hepatic impairment (Child-Pugh class C)&#xD;
  &#xD;
                 -  Pregnant or possibly pregnant women&#xD;
  &#xD;
            3. Patients with a history or complication of cardiac failure&#xD;
  &#xD;
            4. Patients who have been hospitalized at the start of treatment with Entresto&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>99 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>
    <overall_contact>
      <last_name>Novartis Pharmaceuticals</last_name>
      <phone>+81337978748</phone>
      <email>novartis.email@novartis.com</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Novartis Pharmaceuticals</last_name>
    </overall_contact_backup>
    <location>
      <facility>
        <name>Novartis Investigative Site</name>
        <address>
          <city>Kasugai</city>
          <state>Aichi</state>
          <zip>487-0024</zip>
          <country>Japan</country>
        </address>
      </facility>
      <status>Recruiting</status>
    </location>
    <location>
      <facility>
        <name>Novartis Investigative Site</name>
        <address>
          <city>Inzai</city>
          <state>Chiba</state>
          <zip>270-1334</zip>
          <country>Japan</country>
        </address>
      </facility>
      <status>Recruiting</status>
    </location>
    <location>
      <facility>
        <name>Novartis Investigative Site</name>
        <address>
          <city>Saijo</city>
          <state>Ehime</state>
          <zip>799-1371</zip>
          <country>Japan</country>
        </address>
      </facility>
      <status>Recruiting</status>
    </location>
    <location>
      <facility>
        <name>Novartis Investigative Site</name>
        <address>
          <city>Omuta</city>
          <state>Fukuoka</state>
          <zip>837-0916</zip>
          <country>Japan</country>
        </address>
      </facility>
      <status>Recruiting</status>
    </location>
    <location>
      <facility>
        <name>Novartis Investigative Site</name>
        <address>
          <city>Yame</city>
          <state>Fukuoka</state>
          <zip>834-0004</zip>
          <country>Japan</country>
        </address>
      </facility>
      <status>Recruiting</status>
    </location>
    <location>
      <facility>
        <name>Novartis Investigative Site</name>
        <address>
          <city>Yokohama</city>
          <state>Kanagawa</state>
          <zip>241-0821</zip>
          <country>Japan</country>
        </address>
      </facility>
      <status>Recruiting</status>
    </location>
    <location>
      <facility>
        <name>Novartis Investigative Site</name>
        <address>
          <city>Yamaga</city>
          <state>Kumamoto</state>
          <zip>861-0382</zip>
          <country>Japan</country>
        </address>
      </facility>
      <status>Recruiting</status>
    </location>
    <location>
      <facility>
        <name>Novartis Investigative Site</name>
        <address>
          <city>Nakatsu</city>
          <state>Oita</state>
          <zip>871-0152</zip>
          <country>Japan</country>
        </address>
      </facility>
      <status>Recruiting</status>
    </location>
    <location>
      <facility>
        <name>Novartis Investigative Site</name>
        <address>
          <city>Kurashiki</city>
          <state>Okayama</state>
          <zip>710-1101</zip>
          <country>Japan</country>
        </address>
      </facility>
      <status>Recruiting</status>
    </location>
    <location>
      <facility>
        <name>Novartis Investigative Site</name>
        <address>
          <city>Kurashiki</city>
          <state>Okayama</state>
          <zip>713-8121</zip>
          <country>Japan</country>
        </address>
      </facility>
      <status>Recruiting</status>
    </location>
    <location>
      <facility>
        <name>Novartis Investigative Site</name>
        <address>
          <city>Ikeda</city>
          <state>Osaka</state>
          <zip>563-0047</zip>
          <country>Japan</country>
        </address>
      </facility>
      <status>Recruiting</status>
    </location>
    <location>
      <facility>
        <name>Novartis Investigative Site</name>
        <address>
          <city>Tosu</city>
          <state>Saga</state>
          <zip>841-0061</zip>
          <country>Japan</country>
        </address>
      </facility>
      <status>Recruiting</status>
    </location>
    <location>
      <facility>
        <name>Novartis Investigative Site</name>
        <address>
          <city>Kawaguchi</city>
          <state>Saitama</state>
          <zip>333-0847</zip>
          <country>Japan</country>
        </address>
      </facility>
      <status>Recruiting</status>
    </location>
    <location>
      <facility>
        <name>Novartis Investigative Site</name>
        <address>
          <city>Hachioji-city</city>
          <state>Tokyo</state>
          <zip>192-0918</zip>
          <country>Japan</country>
        </address>
      </facility>
      <status>Recruiting</status>
    </location>
    <location>
      <facility>
        <name>Novartis Investigative Site</name>
        <address>
          <city>Koto-ku</city>
          <state>Tokyo</state>
          <zip>135-0003</zip>
          <country>Japan</country>
        </address>
      </facility>
      <status>Recruiting</status>
    </location>
    <location>
      <facility>
        <name>Novartis Investigative Site</name>
        <address>
          <city>Nerima-ku</city>
          <state>Tokyo</state>
          <zip>178-0065</zip>
          <country>Japan</country>
        </address>
      </facility>
      <status>Recruiting</status>
    </location>
    <location>
      <facility>
        <name>Novartis Investigative Site</name>
        <address>
          <city>Setagaya-ku</city>
          <state>Tokyo</state>
          <zip>157-0066</zip>
          <country>Japan</country>
        </address>
      </facility>
      <status>Recruiting</status>
    </location>
    <location>
      <facility>
        <name>Novartis Investigative Site</name>
        <address>
          <city>Fukuoka</city>
          <zip>812-0025</zip>
          <country>Japan</country>
        </address>
      </facility>
      <status>Recruiting</status>
    </location>
    <location>
      <facility>
        <name>Novartis Investigative Site</name>
        <address>
          <city>Fukuoka</city>
          <zip>815-0041</zip>
          <country>Japan</country>
        </address>
      </facility>
      <status>Recruiting</status>
    </location>
    <location>
      <facility>
        <name>Novartis Investigative Site</name>
        <address>
          <city>Hiroshima</city>
          <zip>731-0102</zip>
          <country>Japan</country>
        </address>
      </facility>
      <status>Recruiting</status>
    </location>
    <location>
      <facility>
        <name>Novartis Investigative Site</name>
        <address>
          <city>Hiroshima</city>
          <zip>731-0154</zip>
          <country>Japan</country>
        </address>
      </facility>
      <status>Recruiting</status>
    </location>
    <location>
      <facility>
        <name>Novartis Investigative Site</name>
        <address>
          <city>Oita</city>
          <zip>870-0837</zip>
          <country>Japan</country>
        </address>
      </facility>
      <status>Recruiting</status>
    </location>
    <location>
      <facility>
        <name>Novartis Investigative Site</name>
        <address>
          <city>Osaka</city>
          <zip>534-0024</zip>
          <country>Japan</country>
        </address>
      </facility>
      <status>Recruiting</status>
    </location>
    <location_countries>
      <country>Japan</country>
    </location_countries>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>July 28, 2023</study_first_submitted>
    <study_first_submitted_qc>July 28, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 4, 2023</study_first_posted>
    <last_update_submitted>September 15, 2023</last_update_submitted>
    <last_update_submitted_qc>September 15, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 18, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>hypertension</keyword>
    <keyword>Entresto</keyword>
    <keyword>Entresto Tablets</keyword>
    <keyword>actual clinical practice</keyword>
    <keyword>Japan</keyword>
    <keyword>sacubitril/valsartan</keyword>
    <keyword>sacubitril valsartan sodium hydrate</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Hypertension</mesh_term>
    </condition_browse>
    <intervention_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Sacubitril and valsartan sodium hydrate drug combination</mesh_term>
    </intervention_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT05976230
  org study id: CLCZ696A1402
  nct id: NCT05976230
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  This is a single arm, multicenter, observational study to evaluate the safety and efficacy of
        Entresto Tablets during the first 52 weeks of treatment in Japanese patients with
        hypertension.
  This study is a special drug use surveillance to collect information on the safety
        specifications under the actual clinical practice of Entresto Tablets in patients with
        hypertension in Japan to confirm the occurrence and timing of onset of events related to the
        safety specifications and investigate their risk factors.
  observational model: Cohort
  time perspective: Prospective
  measure: Percentage of patients with hypotension, hyperkalemia, and renal impairment/failure
  time frame: Up to 52 weeks
  description: To investigate the safety of 52 weeks of treatment with Entresto in patients with hypertension in a real-world setting. In particular, the occurrence status of hypotension, hyperkalemia, and renal impairment/renal failure
  measure: Percentage of patients with hypotension, hyperkalemia, and renal impairment/failure by risk factor
  time frame: Up to 52 weeks
  description: To identify risk factors associated with the development of hypotension, hyperkalemia, and renal impairment/failure
  measure: Odds ratio (OR) for each risk factor of hypotension, hyperkalemia, and renal impairment/failure
  time frame: Up to 52 weeks
  description: To identify risk factors associated with the development of hypotension, hyperkalemia, and renal impairment/failure
  measure: Change from baseline in sitting systolic blood pressure (sSBP) and sitting diastolic blood pressure (sDBP) over time
  time frame: Up to 52 weeks
  description: To evaluate the efficacy of 52 weeks of treatment with Entresto in a real-world setting
  measure: Percentage of patients who achieved blood pressure control at each evaluation time point
  time frame: Up to 52 weeks
  description: To evaluate the efficacy of 52 weeks of treatment with Entresto in a real-world setting
  measure: Percentage of patients who achieved improvement in sSBP and sDBP at each evaluation time point
  time frame: Up to 52 weeks
  description: To evaluate the efficacy of 52 weeks of treatment with Entresto in a real-world setting
  arm group label: Entresto
  description: Patients administered Entresto by prescription
  intervention type: Drug
  intervention name: Entresto
  description: There is no treatment allocation. Patients administered Entresto by prescription that have started before inclusion of the patient into the study will be enrolled.
  arm group label: Entresto
  other name: Entresto Tablets
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 99 Years
  healthy volunteers: No
  last name: Novartis Pharmaceuticals
  role: Study Director
  affiliation: Novartis Pharmaceuticals
  last name: Novartis Pharmaceuticals
  phone: +81337978748
  email: novartis.email@novartis.com
  last name: Novartis Pharmaceuticals
  facility: 
  status: Recruiting
  facility: 
  status: Recruiting
  facility: 
  status: Recruiting
  facility: 
  status: Recruiting
  facility: 
  status: Recruiting
  facility: 
  status: Recruiting
  facility: 
  status: Recruiting
  facility: 
  status: Recruiting
  facility: 
  status: Recruiting
  facility: 
  status: Recruiting
  facility: 
  status: Recruiting
  facility: 
  status: Recruiting
  facility: 
  status: Recruiting
  facility: 
  status: Recruiting
  facility: 
  status: Recruiting
  facility: 
  status: Recruiting
  facility: 
  status: Recruiting
  facility: 
  status: Recruiting
  facility: 
  status: Recruiting
  facility: 
  status: Recruiting
  facility: 
  status: Recruiting
  facility: 
  status: Recruiting
  facility: 
  status: Recruiting
  country: Japan
  responsible party type: Sponsor
  mesh term: Hypertension
  mesh term: Sacubitril and valsartan sodium hydrate drug combination
  sharing ipd: No