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/NCT05968430</url>
    </required_header>
    <id_info>
      <org_study_id>MLS-101-901</org_study_id>
      <nct_id>NCT05968430</nct_id>
    </id_info>
    <brief_title>Open-Label Extension Study to Assess Safety, Efficacy, and Tolerability of Lorundrostat in Subjects With Uncontrolled Hypertension</brief_title>
    <official_title>An Open-Label Extension Study to Assess the Long-Term Safety, Efficacy, and Tolerability of Lorundrostat in Subjects With Uncontrolled Hypertension</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Mineralys Therapeutics Inc.</agency>
        <agency_class>Industry</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Mineralys Therapeutics Inc.</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 study is to evaluate the long-term safety, efficacy and tolerability of lorundrostat (an&#xD;
        aldosterone synthase inhibitor) in subjects with uncontrolled hypertension.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        This study is to evaluate the long-term safety, efficacy and tolerability of lorundrostat (an&#xD;
        aldosterone synthase inhibitor) in subjects with uncontrolled hypertension.&#xD;
  &#xD;
        The study consists of an open-label dose treatment period of 48 weeks, followed by a 4-week&#xD;
        double-blind randomized treatment withdrawal sub-study. The study will conclude with a 2-week&#xD;
        wash-out period. To be eligible, subjects must complete the double-blind treatment phase of a&#xD;
        respective parent study (including, but not limited to MLS-101-202 and MLS-101-301) and agree&#xD;
        to transition immediately to this open-label extension (OLE) study (ie, will not participate&#xD;
        in the end of study observation period of the parent study).&#xD;
  &#xD;
        The study will be conducted at approximately 200 centers.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">July 14, 2023</start_date>
    <completion_date type="Anticipated">December 2025</completion_date>
    <primary_completion_date type="Anticipated">December 2025</primary_completion_date>
    <phase>Phase 2/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>
      <intervention_model_description>Double</intervention_model_description>
      <primary_purpose>Treatment</primary_purpose>
      <masking>Double (Participant, Care Provider)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Change in automated office blood pressure (AOBP) systolic blood pressure (SBP)</measure>
      <time_frame>Week 16 to Week 48</time_frame>
    </primary_outcome>
    <secondary_outcome>
      <measure>Change in AOBP SBP in subjects taking lorundrostat at study entry</measure>
      <time_frame>Week 0 - 48</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in AOBP SBP in subjects taking placebo at study entry</measure>
      <time_frame>Week 16 - 48</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in AOBP diastolic blood pressure (DBP) in subjects taking lorundrostat at study entry</measure>
      <time_frame>Week 0 - 48</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in AOBP DBP in subjects taking placebo at study entry</measure>
      <time_frame>Week 16 - 48</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Proportion of subjects with AOBP SBP ≤130 mmHg at each visit</measure>
      <time_frame>Through study completion, up to 54 weeks</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Proportion of subjects with AOBP ≤130/80 mmHg at each visit</measure>
      <time_frame>Through study completion, up to 54 weeks</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>In subjects participating in the randomized withdrawal sub-study, change in AOBP SBP</measure>
      <time_frame>Week 48 to Week 52</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>In subjects participating in the randomized withdrawal sub-study, change in AOBP DBP</measure>
      <time_frame>Week 48 to Week 52</time_frame>
    </secondary_outcome>
    <number_of_arms>4</number_of_arms>
    <enrollment type="Anticipated">900</enrollment>
    <condition>Hypertension</condition>
    <arm_group>
      <arm_group_label>Open-Label Arm</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>lorundrostat once daily for 48 weeks</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Maintenance Arm</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>lorundrostat once daily for 4 weeks in the double-blind randomized treatment withdrawal sub-study</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Taper Arm</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>lorundrostat and/or placebo once daily for 4 weeks in the double-blind randomized treatment withdrawal sub-study</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Placebo</arm_group_label>
      <arm_group_type>Placebo Comparator</arm_group_type>
      <description>Placebo once daily for 4 weeks in the double-blind randomized treatment withdrawal sub-study</description>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>lorundrostat</intervention_name>
      <description>lorundrostat once daily for 48 weeks</description>
      <arm_group_label>Open-Label Arm</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>lorundrostat</intervention_name>
      <description>lorundrostat once daily for 4 weeks</description>
      <arm_group_label>Maintenance Arm</arm_group_label>
      <arm_group_label>Taper Arm</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Placebo</intervention_name>
      <description>Placebo once daily for 4 weeks</description>
      <arm_group_label>Placebo</arm_group_label>
      <arm_group_label>Taper Arm</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            1. Written informed consent signed by the participant, obtained before any study-related&#xD;
               assessment is performed&#xD;
  &#xD;
            2. At least 18 years of age at the time of signing the informed consent form&#xD;
               Participation in a lorundrostat study with the option of transitioning to the OLE&#xD;
               study&#xD;
  &#xD;
            3. Fertile male subjects and female subjects of childbearing potential, and their&#xD;
               partners, must agree to use an acceptable method of contraception from study entry to&#xD;
               28 days after the last dose of study drug&#xD;
  &#xD;
            4. Willing and able to comply with the study instructions and attend all scheduled study&#xD;
               visits&#xD;
  &#xD;
            5. [Randomized treatment withdrawal only] A minimum of 75% and a maximum of 125%&#xD;
               compliance with lorundrostat from Week 32 to Week 48 of the OLE&#xD;
  &#xD;
            6. [Randomized treatment withdrawal only] Taking an oral dose of lorundrostat of at least&#xD;
               25 mg once daily&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            1. Women who are pregnant, plan to become pregnant, or are breast-feeding&#xD;
  &#xD;
            2. In the opinion of the principal investigator, any other condition that will preclude&#xD;
               participation in the study&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_contact>
      <last_name>Shannon Spires</last_name>
      <phone>905-626-1111</phone>
      <email>sspires@mineralystx.com</email>
    </overall_contact>
    <location>
      <facility>
        <name>Del Sol Research Management, LLC</name>
        <address>
          <city>Tucson</city>
          <state>Arizona</state>
          <zip>85715</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Carl Diener</last_name>
        <phone>520-257-3881</phone>
        <email>cdiener@delsolresearch.com</email>
      </contact>
    </location>
    <location>
      <facility>
        <name>CMR of Greater New Haven</name>
        <address>
          <city>Hamden</city>
          <state>Connecticut</state>
          <zip>06512</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Joseph Soufer, MD</last_name>
        <phone>203-373-4373</phone>
        <email>jsoufer@chasemr.com</email>
      </contact>
    </location>
    <location>
      <facility>
        <name>Nuovida Research Center Corp</name>
        <address>
          <city>Miami</city>
          <state>Florida</state>
          <zip>33186</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Luis Diaz-Secades</last_name>
        <phone>305-903-2411</phone>
        <email>diazsecade@gmail.com</email>
      </contact>
    </location>
    <location>
      <facility>
        <name>Patron Medical - Andres Patron D.O. (Patron Ventures, LLC)</name>
        <address>
          <city>Pembroke Pines</city>
          <state>Florida</state>
          <zip>33026</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Andres Patron, DO</last_name>
        <phone>954-885-5555</phone>
        <email>apatron@patronmedical.com</email>
      </contact>
    </location>
    <location>
      <facility>
        <name>Georgia Clinical Research, LLC</name>
        <address>
          <city>Lawrenceville</city>
          <state>Georgia</state>
          <zip>30044</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>John Lentz, MD</last_name>
        <phone>678-822-5581</phone>
        <email>georgiaclinicalresearch@comcast.ne</email>
      </contact>
    </location>
    <location>
      <facility>
        <name>Juno Research, LLC</name>
        <address>
          <city>Houston</city>
          <state>Texas</state>
          <zip>77054</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Rocio Harbison</last_name>
        <phone>713-779-5494</phone>
        <email>Rocio_harbison@junoresearch.us</email>
      </contact>
    </location>
    <location>
      <facility>
        <name>Burke Internal Medicine</name>
        <address>
          <city>Burke</city>
          <state>Virginia</state>
          <zip>22015</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Nashwa Gabra</last_name>
        <phone>703-455-9711</phone>
        <email>nashwagabra@hotmail.com</email>
      </contact>
    </location>
    <location_countries>
      <country>United States</country>
    </location_countries>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>July 14, 2023</study_first_submitted>
    <study_first_submitted_qc>July 26, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 1, 2023</study_first_posted>
    <last_update_submitted>September 13, 2023</last_update_submitted>
    <last_update_submitted_qc>September 13, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 14, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>Blood pressure</keyword>
    <keyword>Uncontrolled hypertension</keyword>
    <keyword>Hypertension</keyword>
    <keyword>Hypertensive</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Hypertension</mesh_term>
    </condition_browse>
    <!-- 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/NCT05968430
  org study id: MLS-101-901
  nct id: NCT05968430
  lead sponsor: 
  has dmc: Yes
  is fda regulated drug: Yes
  is fda regulated device: No
  This study is to evaluate the long-term safety, efficacy and tolerability of lorundrostat (an
        aldosterone synthase inhibitor) in subjects with uncontrolled hypertension.
  This study is to evaluate the long-term safety, efficacy and tolerability of lorundrostat (an
        aldosterone synthase inhibitor) in subjects with uncontrolled hypertension.
  
        The study consists of an open-label dose treatment period of 48 weeks, followed by a 4-week
        double-blind randomized treatment withdrawal sub-study. The study will conclude with a 2-week
        wash-out period. To be eligible, subjects must complete the double-blind treatment phase of a
        respective parent study (including, but not limited to MLS-101-202 and MLS-101-301) and agree
        to transition immediately to this open-label extension (OLE) study (ie, will not participate
        in the end of study observation period of the parent study).
  
        The study will be conducted at approximately 200 centers.
  allocation: Randomized
  intervention model: Parallel Assignment
  intervention model description: Double
  primary purpose: Treatment
  masking: Double (Participant, Care Provider)
  measure: Change in automated office blood pressure (AOBP) systolic blood pressure (SBP)
  time frame: Week 16 to Week 48
  measure: Change in AOBP SBP in subjects taking lorundrostat at study entry
  time frame: Week 0 - 48
  measure: Change in AOBP SBP in subjects taking placebo at study entry
  time frame: Week 16 - 48
  measure: Change in AOBP diastolic blood pressure (DBP) in subjects taking lorundrostat at study entry
  time frame: Week 0 - 48
  measure: Change in AOBP DBP in subjects taking placebo at study entry
  time frame: Week 16 - 48
  measure: Proportion of subjects with AOBP SBP ≤130 mmHg at each visit
  time frame: Through study completion, up to 54 weeks
  measure: Proportion of subjects with AOBP ≤130/80 mmHg at each visit
  time frame: Through study completion, up to 54 weeks
  measure: In subjects participating in the randomized withdrawal sub-study, change in AOBP SBP
  time frame: Week 48 to Week 52
  measure: In subjects participating in the randomized withdrawal sub-study, change in AOBP DBP
  time frame: Week 48 to Week 52
  arm group label: Open-Label Arm
  arm group type: Experimental
  description: lorundrostat once daily for 48 weeks
  arm group label: Maintenance Arm
  arm group type: Experimental
  description: lorundrostat once daily for 4 weeks in the double-blind randomized treatment withdrawal sub-study
  arm group label: Taper Arm
  arm group type: Experimental
  description: lorundrostat and/or placebo once daily for 4 weeks in the double-blind randomized treatment withdrawal sub-study
  arm group label: Placebo
  arm group type: Placebo Comparator
  description: Placebo once daily for 4 weeks in the double-blind randomized treatment withdrawal sub-study
  intervention type: Drug
  intervention name: lorundrostat
  description: lorundrostat once daily for 48 weeks
  arm group label: Open-Label Arm
  intervention type: Drug
  intervention name: lorundrostat
  description: lorundrostat once daily for 4 weeks
  arm group label: Maintenance Arm
  arm group label: Taper Arm
  intervention type: Drug
  intervention name: Placebo
  description: Placebo once daily for 4 weeks
  arm group label: Placebo
  arm group label: Taper Arm
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Shannon Spires
  phone: 905-626-1111
  email: sspires@mineralystx.com
  facility: 
  status: Recruiting
  contact: 
  facility: 
  status: Recruiting
  contact: 
  facility: 
  status: Recruiting
  contact: 
  facility: 
  status: Recruiting
  contact: 
  facility: 
  status: Recruiting
  contact: 
  facility: 
  status: Recruiting
  contact: 
  facility: 
  status: Recruiting
  contact: 
  country: United States
  responsible party type: Sponsor
  mesh term: Hypertension