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/NCT06034743</url>
    </required_header>
    <id_info>
      <org_study_id>D6970C00002</org_study_id>
      <nct_id>NCT06034743</nct_id>
    </id_info>
    <brief_title>A Study to Investigate the Efficacy and Safety of Baxdrostat in Participants With Uncontrolled Hypertension on Two or More Medications Including Participants With Resistant Hypertension</brief_title>
    <acronym>BaxHTN</acronym>
    <official_title>A Randomised, Double-Blind, Placebo-Controlled, Parallel Group Study to Assess the Efficacy and Safety of Baxdrostat in Participants With Uncontrolled Hypertension on Two or More Medications Including Participants With Resistant Hypertension</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>AstraZeneca</agency>
        <agency_class>Industry</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>AstraZeneca</source>
    <oversight_info>
      <has_dmc>Yes</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>
        This is a Phase III, multicentre, randomised, double-blinded, placebo-controlled, parallel&#xD;
        group study to evaluate the safety, tolerability and effect of 1 or 2 mg baxdrostat versus&#xD;
        placebo, administered once daily (QD) orally, on the reduction of systolic blood pressure in&#xD;
        approximately 720 participants aged ≥ 18 years with hypertension, despite a stable regimen of&#xD;
        2 antihypertensive agents at baseline, one of which is a diuretic (uncontrolled&#xD;
        hypertension); or ≥ 3 antihypertensive agents at baseline, one of which is a diuretic&#xD;
        (treatment-resistant hypertension).&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">December 1, 2023</start_date>
    <completion_date type="Anticipated">October 13, 2025</completion_date>
    <primary_completion_date type="Anticipated">October 13, 2025</primary_completion_date>
    <phase>Phase 3</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>Randomized</allocation>
      <intervention_model>Parallel Assignment</intervention_model>
      <primary_purpose>Treatment</primary_purpose>
      <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Change from baseline in seated systolic blood pressure for 2 mg baxdrostat</measure>
      <time_frame>At Week 12</time_frame>
      <description>To assess the effect of 2 mg baxdrostat versus placebo on seated systolic blood pressure at Week 12</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Change from baseline in seated systolic blood pressure for 1 mg baxdrostat</measure>
      <time_frame>At Week 12</time_frame>
      <description>To assess the effect of 1 mg baxdrostat versus placebo on seated systolic blood pressure at Week 12</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Change from randomised withdrawal baseline (Week 24) in seated systolic blood pressure (SBP) for 2 mg baxdrostat</measure>
      <time_frame>At Week 32</time_frame>
      <description>To assess the effect of 2 mg baxdrostat vs placebo on seated systolic blood pressure (SBP) at 8 weeks after randomised withdrawal</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change from baseline in seated SBP for 2 mg baxdrostat</measure>
      <time_frame>At Week 12</time_frame>
      <description>To assess the effect of 2 mg baxdrostat vs placebo on seated SBP at Week 12 in the resistant hypertension (rHTN) subpopulation</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change from baseline in seated diastolic blood pressure (DBP) for 2 mg baxdrostat</measure>
      <time_frame>At Week 12</time_frame>
      <description>To assess the effect of 2 mg baxdrostat vs placebo on seated diastolic blood pressure (DBP) at Week 12</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Achieving seated SBP &lt; 130 mmHg for 2 mg baxdrostat</measure>
      <time_frame>At Week 12</time_frame>
      <description>To assess the effect of 2 mg baxdrostat vs placebo on achieving seated SBP &lt; 130 mmHg at Week 12</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change from baseline in seated SBP for 1 mg baxdrostat</measure>
      <time_frame>At Week 12</time_frame>
      <description>To assess the effect of 1 mg baxdrostat vs placebo on seated SBP at Week 12 in the rHTN subpopulation</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change from baseline in seated DBP for 1 mg baxdrostat</measure>
      <time_frame>At Week 12</time_frame>
      <description>To assess the effect of 1 mg baxdrostat vs placebo on seated DBP at Week 12</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Achieving seated SBP &lt; 130 mmHg for 1 mg baxdrostat</measure>
      <time_frame>At Week 12</time_frame>
      <description>To assess the effect of 1 mg baxdrostat vs placebo on achieving seated SBP &lt; 130 mmHg at Week 12</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>The change from baseline in the mean ambulatory 24-hour SBP as measured by ambulatory blood pressure monitoring (ABPM) for 2 mg baxdrostat</measure>
      <time_frame>At Week 12</time_frame>
      <description>To assess the effect of treatment with baxdrostat 2 mg vs placebo on ambulatory 24-hour average SBP at Week 12</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>The change from baseline in the mean ambulatory 24-hour SBP as measured by ABPM for 1 mg baxdrostat</measure>
      <time_frame>At Week 12</time_frame>
      <description>To assess the effect of treatment with baxdrostat 1 mg vs placebo on ambulatory 24-hour average SBP at Week 12</description>
    </secondary_outcome>
    <other_outcome>
      <measure>Number of participants with adverse events (AEs)</measure>
      <time_frame>Up to Week 54</time_frame>
      <description>To assess the safety and tolerability of baxdrostat versus placebo. Occurrence of adverse events (AE), including serious adverse events (SAEs), adverse events leading to treatment discontinuation (DAE) and adverse events of special interest (AESI).</description>
    </other_outcome>
    <number_of_arms>3</number_of_arms>
    <enrollment type="Anticipated">720</enrollment>
    <condition>Uncontrolled Hypertension</condition>
    <condition>Resistant Hypertension</condition>
    <arm_group>
      <arm_group_label>2 mg baxdrostat</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>2 mg baxdrostat administered orally, once daily (QD).</description>
    </arm_group>
    <arm_group>
      <arm_group_label>1 mg baxdrostat</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>1 mg baxdrostat administered orally, once daily (QD).</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Placebo</arm_group_label>
      <arm_group_type>Placebo Comparator</arm_group_type>
      <description>Placebo administered orally, once daily (QD).</description>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Baxdrostat</intervention_name>
      <description>Baxdrostat tablet administered orally, once daily (QD). Unit dose strengths:&#xD;
  1 mg per tablet for 1 mg baxdrostat Arm;&#xD;
  2 mg per tablet for 2 mg baxdrostat Arm.</description>
      <arm_group_label>1 mg baxdrostat</arm_group_label>
      <arm_group_label>2 mg baxdrostat</arm_group_label>
      <other_name>CIN-107</other_name>
    </intervention>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Placebo</intervention_name>
      <description>Placebo tablet matching baxdrostat, administered orally, once daily (QD).</description>
      <arm_group_label>Placebo</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Male or female participants must be ≥ 18 years old&#xD;
  &#xD;
            -  Mean sitting systolic blood pressure on automated office blood pressure measurement ≥&#xD;
               140 mmHg and &lt; 170 mmHg at Screening&#xD;
  &#xD;
            -  Fulfil at least 1 of the following 2 criteria:&#xD;
  &#xD;
                 1. uHTN subpopulation: have a stable regimen of 2 antihypertensive medications, from&#xD;
                    different therapeutic classes (at least one should be a diuretic), at maximum&#xD;
                    tolerated dose in the judgement of the Investigator&#xD;
  &#xD;
                 2. rHTN subpopulation: have a stable regimen of ≥ 3 antihypertensive medications,&#xD;
                    from different therapeutic classes (at least one should be a diuretic), at&#xD;
                    maximum tolerated dose in the judgement of the Investigator&#xD;
  &#xD;
            -  Estimated glomerular filtration rate ≥ 45 mL/min/1.73m2 at Screening&#xD;
  &#xD;
            -  Serum potassium (K+) level ≥ 3.5 and &lt; 5.0 mmol/L at Screening&#xD;
  &#xD;
            -  Randomisation Criterion:&#xD;
  &#xD;
            -  Sitting systolic blood pressure on attended automated office blood pressure&#xD;
               measurement of ≥ 135 mmHg at baseline&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Mean sitting systolic blood pressure on attended automated office blood pressure&#xD;
               measurement ≥ 170 mmHg at Randomisation&#xD;
  &#xD;
            -  Mean seated diastolic blood pressure on attended automated office blood pressure&#xD;
               measurement ≥ 110 mmHg at Randomisation&#xD;
  &#xD;
            -  Serum sodium level &lt; 135 mmol/L at Screening&#xD;
  &#xD;
            -  Has the following known secondary causes of hypertension: renal artery stenosis,&#xD;
               uncontrolled or untreated hyperthyroidism, uncontrolled or untreated hypothyroidism,&#xD;
               pheochromocytoma, Cushing's syndrome, aortic coarctation&#xD;
  &#xD;
            -  New York Heart Association functional heart failure class IV at Screening&#xD;
  &#xD;
            -  Persistent atrial fibrillation&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>130 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_contact>
      <last_name>AstraZeneca Clinical Study Information Center</last_name>
      <phone>1-877-240-9479</phone>
      <email>information.center@astrazeneca.com</email>
    </overall_contact>
    <location>
      <facility>
        <name>Research Site</name>
        <address>
          <city>Saraland</city>
          <state>Alabama</state>
          <zip>36571</zip>
          <country>United States</country>
        </address>
      </facility>
    </location>
    <location>
      <facility>
        <name>Research Site</name>
        <address>
          <city>Sun City West</city>
          <state>Arizona</state>
          <zip>85375</zip>
          <country>United States</country>
        </address>
      </facility>
    </location>
    <location>
      <facility>
        <name>Research Site</name>
        <address>
          <city>Surprise</city>
          <state>Arizona</state>
          <zip>85374</zip>
          <country>United States</country>
        </address>
      </facility>
    </location>
    <location>
      <facility>
        <name>Research Site</name>
        <address>
          <city>Anaheim</city>
          <state>California</state>
          <zip>92805</zip>
          <country>United States</country>
        </address>
      </facility>
    </location>
    <location>
      <facility>
        <name>Research Site</name>
        <address>
          <city>Lincoln</city>
          <state>California</state>
          <zip>95648</zip>
          <country>United States</country>
        </address>
      </facility>
    </location>
    <location>
      <facility>
        <name>Research Site</name>
        <address>
          <city>Stanford</city>
          <state>California</state>
          <zip>94304</zip>
          <country>United States</country>
        </address>
      </facility>
    </location>
    <location>
      <facility>
        <name>Research Site</name>
        <address>
          <city>Clearwater</city>
          <state>Florida</state>
          <zip>33765</zip>
          <country>United States</country>
        </address>
      </facility>
    </location>
    <location>
      <facility>
        <name>Research Site</name>
        <address>
          <city>Atlanta</city>
          <state>Georgia</state>
          <zip>30344</zip>
          <country>United States</country>
        </address>
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    </location>
    <location>
      <facility>
        <name>Research Site</name>
        <address>
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          <state>Illinois</state>
          <zip>60612</zip>
          <country>United States</country>
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    <location>
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        <name>Research Site</name>
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          <zip>60523</zip>
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        <name>Research Site</name>
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          <state>Massachusetts</state>
          <zip>02215</zip>
          <country>United States</country>
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        <name>Research Site</name>
        <address>
          <city>Muang</city>
          <zip>22000</zip>
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        </address>
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    </location>
    <location_countries>
      <country>Argentina</country>
      <country>Australia</country>
      <country>Austria</country>
      <country>Belgium</country>
      <country>Bulgaria</country>
      <country>Canada</country>
      <country>Czechia</country>
      <country>Germany</country>
      <country>Hungary</country>
      <country>India</country>
      <country>Israel</country>
      <country>Netherlands</country>
      <country>Poland</country>
      <country>Slovakia</country>
      <country>Taiwan</country>
      <country>Thailand</country>
      <country>United States</country>
    </location_countries>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>September 6, 2023</study_first_submitted>
    <study_first_submitted_qc>September 6, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 13, 2023</study_first_posted>
    <last_update_submitted>September 6, 2023</last_update_submitted>
    <last_update_submitted_qc>September 6, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 13, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>Hypertension</keyword>
    <keyword>Uncontrolled hypertension</keyword>
    <keyword>Resistant hypertension</keyword>
    <keyword>Blood pressure</keyword>
    <keyword>Baxdrostat</keyword>
    <keyword>CIN-107</keyword>
    <keyword>Aldosterone</keyword>
    <keyword>Aldosterone synthase</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Hypertension</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>Yes</sharing_ipd>
      <ipd_description>Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal Vivli.org. All requests will be evaluated as per the AZ disclosure commitment:&#xD;
  https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.&#xD;
  &quot;Yes&quot;, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be approved.</ipd_description>
      <ipd_info_type>Study Protocol</ipd_info_type>
      <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
      <ipd_time_frame>AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA/PhRMA Data-Sharing Principles. For details of our timelines, please refer to our disclosure commitment at:&#xD;
  https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.</ipd_time_frame>
      <ipd_access_criteria>When a request has been approved AstraZeneca will provide access to the anonymized individual patient-level data via secure research environment Vivli.org. A Signed Data Usage Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information.</ipd_access_criteria>
      <ipd_url>https://vivli.org/</ipd_url>
    </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/NCT06034743
  org study id: D6970C00002
  nct id: NCT06034743
  lead sponsor: 
  has dmc: Yes
  is fda regulated drug: Yes
  is fda regulated device: No
  This is a Phase III, multicentre, randomised, double-blinded, placebo-controlled, parallel
        group study to evaluate the safety, tolerability and effect of 1 or 2 mg baxdrostat versus
        placebo, administered once daily (QD) orally, on the reduction of systolic blood pressure in
        approximately 720 participants aged ≥ 18 years with hypertension, despite a stable regimen of
        2 antihypertensive agents at baseline, one of which is a diuretic (uncontrolled
        hypertension); or ≥ 3 antihypertensive agents at baseline, one of which is a diuretic
        (treatment-resistant hypertension).
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Treatment
  masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  measure: Change from baseline in seated systolic blood pressure for 2 mg baxdrostat
  time frame: At Week 12
  description: To assess the effect of 2 mg baxdrostat versus placebo on seated systolic blood pressure at Week 12
  measure: Change from baseline in seated systolic blood pressure for 1 mg baxdrostat
  time frame: At Week 12
  description: To assess the effect of 1 mg baxdrostat versus placebo on seated systolic blood pressure at Week 12
  measure: Change from randomised withdrawal baseline (Week 24) in seated systolic blood pressure (SBP) for 2 mg baxdrostat
  time frame: At Week 32
  description: To assess the effect of 2 mg baxdrostat vs placebo on seated systolic blood pressure (SBP) at 8 weeks after randomised withdrawal
  measure: Change from baseline in seated SBP for 2 mg baxdrostat
  time frame: At Week 12
  description: To assess the effect of 2 mg baxdrostat vs placebo on seated SBP at Week 12 in the resistant hypertension (rHTN) subpopulation
  measure: Change from baseline in seated diastolic blood pressure (DBP) for 2 mg baxdrostat
  time frame: At Week 12
  description: To assess the effect of 2 mg baxdrostat vs placebo on seated diastolic blood pressure (DBP) at Week 12
  measure: Achieving seated SBP < 130 mmHg for 2 mg baxdrostat
  time frame: At Week 12
  description: To assess the effect of 2 mg baxdrostat vs placebo on achieving seated SBP < 130 mmHg at Week 12
  measure: Change from baseline in seated SBP for 1 mg baxdrostat
  time frame: At Week 12
  description: To assess the effect of 1 mg baxdrostat vs placebo on seated SBP at Week 12 in the rHTN subpopulation
  measure: Change from baseline in seated DBP for 1 mg baxdrostat
  time frame: At Week 12
  description: To assess the effect of 1 mg baxdrostat vs placebo on seated DBP at Week 12
  measure: Achieving seated SBP < 130 mmHg for 1 mg baxdrostat
  time frame: At Week 12
  description: To assess the effect of 1 mg baxdrostat vs placebo on achieving seated SBP < 130 mmHg at Week 12
  measure: The change from baseline in the mean ambulatory 24-hour SBP as measured by ambulatory blood pressure monitoring (ABPM) for 2 mg baxdrostat
  time frame: At Week 12
  description: To assess the effect of treatment with baxdrostat 2 mg vs placebo on ambulatory 24-hour average SBP at Week 12
  measure: The change from baseline in the mean ambulatory 24-hour SBP as measured by ABPM for 1 mg baxdrostat
  time frame: At Week 12
  description: To assess the effect of treatment with baxdrostat 1 mg vs placebo on ambulatory 24-hour average SBP at Week 12
  measure: Number of participants with adverse events (AEs)
  time frame: Up to Week 54
  description: To assess the safety and tolerability of baxdrostat versus placebo. Occurrence of adverse events (AE), including serious adverse events (SAEs), adverse events leading to treatment discontinuation (DAE) and adverse events of special interest (AESI).
  arm group label: 2 mg baxdrostat
  arm group type: Experimental
  description: 2 mg baxdrostat administered orally, once daily (QD).
  arm group label: 1 mg baxdrostat
  arm group type: Experimental
  description: 1 mg baxdrostat administered orally, once daily (QD).
  arm group label: Placebo
  arm group type: Placebo Comparator
  description: Placebo administered orally, once daily (QD).
  intervention type: Drug
  intervention name: Baxdrostat
  description: Baxdrostat tablet administered orally, once daily (QD). Unit dose strengths:
  1 mg per tablet for 1 mg baxdrostat Arm;
  2 mg per tablet for 2 mg baxdrostat Arm.
  arm group label: 1 mg baxdrostat
  arm group label: 2 mg baxdrostat
  other name: CIN-107
  intervention type: Drug
  intervention name: Placebo
  description: Placebo tablet matching baxdrostat, administered orally, once daily (QD).
  arm group label: Placebo
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 130 Years
  healthy volunteers: No
  last name: AstraZeneca Clinical Study Information Center
  phone: 1-877-240-9479
  email: information.center@astrazeneca.com
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  country: Argentina
  country: Australia
  country: Austria
  country: Belgium
  country: Bulgaria
  country: Canada
  country: Czechia
  country: Germany
  country: Hungary
  country: India
  country: Israel
  country: Netherlands
  country: Poland
  country: Slovakia
  country: Taiwan
  country: Thailand
  country: United States
  responsible party type: Sponsor
  mesh term: Hypertension
  sharing ipd: Yes
  ipd description: Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal Vivli.org. All requests will be evaluated as per the AZ disclosure commitment:
  https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
  "Yes", indicates that AZ are accepting requests for IPD, but this does not mean all requests will be approved.
  ipd info type: Study Protocol
  ipd info type: Statistical Analysis Plan (SAP)
  ipd time frame: AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA/PhRMA Data-Sharing Principles. For details of our timelines, please refer to our disclosure commitment at:
  https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
  ipd access criteria: When a request has been approved AstraZeneca will provide access to the anonymized individual patient-level data via secure research environment Vivli.org. A Signed Data Usage Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information.
  ipd url: https://vivli.org/