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/NCT05963009</url>
    </required_header>
    <id_info>
      <org_study_id>CIN-107-112</org_study_id>
      <nct_id>NCT05963009</nct_id>
    </id_info>
    <brief_title>Baxdrostat Bioavailability and Bioequivalence Study</brief_title>
    <official_title>Randomized, Open Label, Crossover Study to Evaluate the Relative Bioavailability of a New Tablet Formulation of CIN-107 as Compared to Oral Solution and to Assess the Effect of Food on the CIN-107 Tablet Formulation in Healthy Subjects</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>AstraZeneca</agency>
        <agency_class>Industry</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>AstraZeneca</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 goal of this study was to compare the characteristics of a new tablet formulation versus&#xD;
        an oral solution of CIN-107 (baxdrostat) in terms of CIN-107 levels over time in the blood&#xD;
        and to compare the effect of food on these parameters in healthy volunteer participants who&#xD;
        received the CIN-107 tablet under fed versus fasted conditions.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        The goals of this study were to:&#xD;
  &#xD;
          1. To assess the safety and tolerability of single doses of CIN-107 tablet and oral&#xD;
             solution in healthy participants.&#xD;
  &#xD;
          2. Compare CIN-107 levels over time in the blood in participants after dosing between a&#xD;
             tablet formulation of CIN-107 as compared to the oral solution.&#xD;
  &#xD;
          3. Compare the CIN-107 levels over time in the blood in participants following dosing with&#xD;
             a CIN-107 tablet after a meal versus in the fasted state.&#xD;
  &#xD;
        Participants took either the oral solution or a tablet of CIN-107 and had their safety and&#xD;
        blood levels of CIN-107 measured over several days following administration of CIN-107 tablet&#xD;
        either in the fasted state or after a meal. The CIN-107 blood levels over time were compared&#xD;
        between the groups given either the oral solution or the tablet and between the group given&#xD;
        the CIN-107 tablet with a meal versus in the fasted state.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Completed</overall_status>
    <start_date type="Actual">March 11, 2020</start_date>
    <completion_date type="Actual">April 29, 2020</completion_date>
    <primary_completion_date type="Actual">April 29, 2020</primary_completion_date>
    <phase>Phase 1</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>Randomized</allocation>
      <intervention_model>Crossover Assignment</intervention_model>
      <intervention_model_description>Randomized Crossover between 1) oral solution, 2) tablet in the fasted state, and 3) tablet in the fed state</intervention_model_description>
      <primary_purpose>Treatment</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Incidence of treatment emergent adverse events following single oral doses of CIN-107 tablet and oral solution.</measure>
      <time_frame>0 to 23 days after dosing</time_frame>
      <description>The safety and tolerability of CIN-107 will be assessed throughout the study based on quantitation of adverse events that occur following oral doses of CIN-107 tablet and oral solution.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Maximum concentration [Cmax] following administration of a tablet formulation of CIN-107 compared to Cmax following administration of the oral solution.</measure>
      <time_frame>0 to 21 days after dosing</time_frame>
      <description>Cmax will be determined for CIN-107 and any other measured metabolites for participants given each formulation of baxdrostat; relative bioavailability will be evaluated by comparing these parameters between patients given the solution versus the tablet.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Cmax of CIN-107 following administration of the tablet formulation under fed versus fasted conditions.</measure>
      <time_frame>0 to 21 days after dosing</time_frame>
      <description>Cmax will be determined for CIN-107 and any other measured metabolites for participants given baxdrostat under fed versus fasted conditions; food effect will be evaluated by comparing Cmax between participants under each condition.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Area under the curve [AUC] following administration of a tablet formulation of CIN-107 compared to AUC following administration of the oral solution.</measure>
      <time_frame>0 to 21 days after dosing</time_frame>
      <description>Area under the curve (AUC)0-∞ and AUC0-last will be determined for baxdrostat and any other measured metabolites for participants given each formulation of baxdrostat. Then relative bioavailability will be evaluated by comparing these AUC parameters between patients given the solution versus the tablet.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Time to maximum concentration [Tmax] of CIN-107 following administration of the tablet formulation under fed versus fasted conditions.</measure>
      <time_frame>0 to 21 days after dosing</time_frame>
      <description>Tmax will be determined for CIN-107 and any other measured metabolites for participants given baxdrostat under fed versus fasted conditions, and then food effect will be evaluated by comparing Tmax between participants under each condition.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>AUC of CIN-107 following administration of the tablet formulation under fed versus fasted conditions.</measure>
      <time_frame>0 to 21 days after dosing</time_frame>
      <description>Area under the curve (AUC)0-∞ and AUC0-last will be determined for CIN-107 and any other measured metabolites for participants given baxdrostat under fed versus fasted conditions, and then food effect will be evaluated by comparing AUC between participants under each condition.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Tmax following administration of a tablet formulation of CIN-107 compared to Tmax following administration of the oral solution.</measure>
      <time_frame>0 to 21 days after dosing</time_frame>
      <description>Tmax will be determined for CIN-107 and any other measured metabolites for participants given each formulation of baxdrostat.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Angiotensin converting enzyme (ACE) levels following single doses of CIN-107.</measure>
      <time_frame>0 to 21 days after dosing</time_frame>
      <description>An exploratory assessment of the effect of CIN-107 on various measures associated with the Renin-Angiotensin-Aldosterone system including, but not limited to, angiotensin converting enzyme (ACE).</description>
    </secondary_outcome>
    <number_of_arms>3</number_of_arms>
    <enrollment type="Actual">14</enrollment>
    <condition>Hypertension</condition>
    <arm_group>
      <arm_group_label>Baxdrostat oral solution</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>5 mg CIN-107 oral solution in a fasted state</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Baxdrostat tablet (fasted state)</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>5 mg CIN-107 tablet(s) in a fasted state</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Baxdrostat tablet (fed state)</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>5 mg CIN-107 tablet(s) in a fed state (standard high fat meal)</description>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>baxdrostat (formerly CIN-107) oral solution</intervention_name>
      <description>5 mg single dose of baxdrostat given as either a solution or tablet in either the fed or fasted state, depending on the arm of the study</description>
      <arm_group_label>Baxdrostat oral solution</arm_group_label>
      <arm_group_label>Baxdrostat tablet (fasted state)</arm_group_label>
      <arm_group_label>Baxdrostat tablet (fed state)</arm_group_label>
      <other_name>baxdrostat (formerly CIN-107) tablet</other_name>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            1. Healthy subjects between the ages of 18 and 55 years, inclusive, in good health based&#xD;
               on medical and psychiatric history, physical examination, electrocardiogram (ECG),&#xD;
               vital signs (seated and orthostatic), and routine laboratory tests (blood chemistry,&#xD;
               hematology, coagulation, and urinalysis).&#xD;
  &#xD;
            2. Body mass index (BMI) between 18 and 30 kg/m2, inclusive.&#xD;
  &#xD;
            3. Nonsmokers who have not used nicotine-containing products for at least 6 months prior&#xD;
               to Screening.&#xD;
  &#xD;
            4. Male subjects with female partners of child-bearing potential must agree to use two&#xD;
               medically accepted, highly effective methods of birth control from Day 1 through 90&#xD;
               days after the final dose of study drug.&#xD;
  &#xD;
            5. Male subjects must agree to abstain from sperm donation from Day 1 through 90 days&#xD;
               after administration of the final dose of study drug.&#xD;
  &#xD;
            6. Female subjects with male partners must be surgically sterile (hysterectomy and/or&#xD;
               bilateral oophorectomy), postmenopausal for at least 1 year (with follicle-stimulating&#xD;
               hormone in postmenopausal range), or agree to use two medically accepted, highly&#xD;
               effective methods of birth control from Day -14 until 60 days following the final dose&#xD;
               of study drug.&#xD;
  &#xD;
            7. Able to understand and willing to comply with study procedures and restrictions&#xD;
               (including confinement to the clinical unit, fasting and meal requirements, and&#xD;
               restrictions on physical activity, use of recreational drugs or alcohol, and&#xD;
               medications), and provide written informed consent according to institutional and&#xD;
               regulatory guidelines.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            1. Actively participating in an experimental therapy study; received experimental therapy&#xD;
               with a small molecule other than CIN-107 within 30 days of the first dose of study&#xD;
               drug, or 5 halflives, whichever is longer; or received experimental therapy with a&#xD;
               large molecule within 90 days of the first dose of study drug, or 5 half-lives,&#xD;
               whichever is longer.&#xD;
  &#xD;
            2. A personal or family history of long QT syndrome, Torsades de Pointes, or other&#xD;
               complex ventricular arrhythmias, or family history of sudden death.&#xD;
  &#xD;
            3. History of, or current, clinically significant arrhythmias as judged by the&#xD;
               Investigator, including ventricular tachycardia, ventricular fibrillation, atrial&#xD;
               fibrillation, sinus node dysfunction, or clinically significant heart block. Subjects&#xD;
               with minor forms of ectopy (eg, premature atrial contractions) are not necessarily&#xD;
               excluded.&#xD;
  &#xD;
            4. Prolonged QTcF (&gt;450 msec).&#xD;
  &#xD;
            5. Seated blood pressure higher than 150/90 mmHg or lower than 90/50.&#xD;
  &#xD;
            6. Resting heart rate higher than 100 bpm or lower than 50 bpm.&#xD;
  &#xD;
            7. Temperature (T) greater than 37.6 C (99.68 F), measured orally, and respiration rate&#xD;
               less than 12 or greater than 20 breaths/minute.&#xD;
  &#xD;
            8. Postural tachycardia (i.e. &gt;30 bpm upon standing) or orthostatic hypotension (i.e., a&#xD;
               fall in systolic blood pressure (SBP) of ≥20 mm Hg or diastolic blood pressure (DBP)&#xD;
               of ≥ 10 mm Hg when a person assumes a standing position).&#xD;
  &#xD;
            9. Serum potassium &gt; upper limit of normal of the reference range (ULN) and serum sodium&#xD;
               &lt; lower limit of normal of the reference range (LLN).&#xD;
  &#xD;
           10. Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) values &gt; 1.2 ULN.&#xD;
  &#xD;
           11. Positive for human immunodeficiency virus (HIV) antibody, hepatitis C virus (HCV)&#xD;
               antibody, or Hepatitis B surface antigen (HBsAg).&#xD;
  &#xD;
           12. Any other clinical laboratory values which are meaningfully outside of normal limits&#xD;
               (based on laboratory normal range) in the opinion of the Investigator.&#xD;
  &#xD;
           13. A known history of porphyria, myopathy, or an active liver disease.&#xD;
  &#xD;
           14. Evidence or history of any clinically significant immunologic, hematologic, renal,&#xD;
               endocrine, pulmonary, gastrointestinal, cardiovascular, musculoskeletal, hepatic,&#xD;
               psychiatric, neurologic, or allergic disease (including clinically significant or&#xD;
               multiple drug allergies); surgical conditions; cancer (with the exception of basal or&#xD;
               squamous cell carcinoma of the skin and cancer that resolved or has been in remission&#xD;
               for &gt;5 years prior to Screening); or any condition that, in the Investigator's&#xD;
               opinion, may confound study procedures or results, impact subject safety, or interfere&#xD;
               with the absorption, distribution, metabolism, or excretion of the study drug&#xD;
               (appendectomy allowed, cholecystectomy prohibited).&#xD;
  &#xD;
           15. Use of any prescription medications (including topicals) or over-the-counter&#xD;
               medications (other than occasional use of acetaminophen or nonsteroidal&#xD;
               anti-inflammatory drugs, such as ibuprofen or naproxen, according to the package&#xD;
               insert); herbal supplements; dietary supplements; or nutraceuticals within 14 days&#xD;
               prior to the first dose of study drug, or 5 halflives, whichever is longer, or an&#xD;
               unwillingness to refrain from these medications through discharge from the clinical&#xD;
               unit. Note: Use of over-the-counter topical medications may be permitted in&#xD;
               consultation with the Sponsor. In addition, medications for which 5 half-lives exceeds&#xD;
               14 days must be discussed with and approved by the Sponsor prior to subject&#xD;
               enrollment.&#xD;
  &#xD;
           16. Corticosteroid use (systemic or extensive topical) within 3 months prior to dosing.&#xD;
  &#xD;
           17. Positive drug or alcohol test result or a history of alcoholism or drug abuse within 2&#xD;
               years prior to the first dose of study drug as defined by the Diagnostic and&#xD;
               Statistical Manual (DSM) of Mental Disorders, 4th Edition: DSM-IV.&#xD;
  &#xD;
           18. Typical consumption of ≥14 alcoholic drinks weekly. Note: 1 drink of alcohol is&#xD;
               equivalent to ½ pint of beer (285 mL), 1 glass of spirits (25 mL), or 1 glass of wine&#xD;
               (125 mL).&#xD;
  &#xD;
           19. History of or evidence of illicit drug use within the past 2 years.&#xD;
  &#xD;
           20. Surgical procedures within 4 weeks of check-in or planned elective surgery during the&#xD;
               study period.&#xD;
  &#xD;
           21. Any illness during the 4 weeks before check-in, unless deemed not clinically&#xD;
               significant by the Investigator.&#xD;
  &#xD;
           22. Known allergy to any ingredient of the study drug. Any history of severe allergic&#xD;
               reaction (including drugs, food, insect bites, environmental allergens).&#xD;
  &#xD;
           23. Inadequate venous access.&#xD;
  &#xD;
           24. Currently undergoing treatment with weight loss medication or prior weight loss&#xD;
               surgery (e.g., gastric bypass surgery).&#xD;
  &#xD;
           25. Pregnant, breastfeeding, or planning to become pregnant during the study.&#xD;
  &#xD;
           26. Considered by the Investigator, after reviewing medical and psychiatric history,&#xD;
               physical examination, and laboratory evaluation, to be unsuitable for any other reason&#xD;
               that may either place the subject at increased risk during participation or interfere&#xD;
               with the interpretation of the study outcomes.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>55 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>L Vrishabhendra, MD</last_name>
      <role>Principal Investigator</role>
      <affiliation>Medpace, Inc.</affiliation>
    </overall_official>
    <location>
      <facility>
        <name>Medpace</name>
        <address>
          <city>Cincinnati</city>
          <state>Ohio</state>
          <zip>45227</zip>
          <country>United States</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>United States</country>
    </location_countries>
    <link>
      <url>https://filehosting-v2.pharmacm.com/api/Attachment/Download?tenantId=80217111&amp;parentIdentifier=CIN-107-112&amp;attachmentIdentifier=987d2c9f-2754-478e-bc37-f0963da20509&amp;fileName=cin-107-112-report-synopsis_Redacted.pdf&amp;versionIdentifier=</url>
      <description>Redacted CSR Synopsis</description>
    </link>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>July 3, 2023</study_first_submitted>
    <study_first_submitted_qc>July 18, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">July 27, 2023</study_first_posted>
    <last_update_submitted>August 9, 2023</last_update_submitted>
    <last_update_submitted_qc>August 9, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 14, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>pharmacokinetics (PK)</keyword>
    <keyword>food effect</keyword>
    <keyword>bioavailability</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: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. &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 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/NCT05963009
  org study id: CIN-107-112
  nct id: NCT05963009
  lead sponsor: 
  has dmc: No
  is fda regulated drug: Yes
  is fda regulated device: No
  The goal of this study was to compare the characteristics of a new tablet formulation versus
        an oral solution of CIN-107 (baxdrostat) in terms of CIN-107 levels over time in the blood
        and to compare the effect of food on these parameters in healthy volunteer participants who
        received the CIN-107 tablet under fed versus fasted conditions.
  The goals of this study were to:
  
          1. To assess the safety and tolerability of single doses of CIN-107 tablet and oral
             solution in healthy participants.
  
          2. Compare CIN-107 levels over time in the blood in participants after dosing between a
             tablet formulation of CIN-107 as compared to the oral solution.
  
          3. Compare the CIN-107 levels over time in the blood in participants following dosing with
             a CIN-107 tablet after a meal versus in the fasted state.
  
        Participants took either the oral solution or a tablet of CIN-107 and had their safety and
        blood levels of CIN-107 measured over several days following administration of CIN-107 tablet
        either in the fasted state or after a meal. The CIN-107 blood levels over time were compared
        between the groups given either the oral solution or the tablet and between the group given
        the CIN-107 tablet with a meal versus in the fasted state.
  allocation: Randomized
  intervention model: Crossover Assignment
  intervention model description: Randomized Crossover between 1) oral solution, 2) tablet in the fasted state, and 3) tablet in the fed state
  primary purpose: Treatment
  masking: None (Open Label)
  measure: Incidence of treatment emergent adverse events following single oral doses of CIN-107 tablet and oral solution.
  time frame: 0 to 23 days after dosing
  description: The safety and tolerability of CIN-107 will be assessed throughout the study based on quantitation of adverse events that occur following oral doses of CIN-107 tablet and oral solution.
  measure: Maximum concentration [Cmax] following administration of a tablet formulation of CIN-107 compared to Cmax following administration of the oral solution.
  time frame: 0 to 21 days after dosing
  description: Cmax will be determined for CIN-107 and any other measured metabolites for participants given each formulation of baxdrostat; relative bioavailability will be evaluated by comparing these parameters between patients given the solution versus the tablet.
  measure: Cmax of CIN-107 following administration of the tablet formulation under fed versus fasted conditions.
  time frame: 0 to 21 days after dosing
  description: Cmax will be determined for CIN-107 and any other measured metabolites for participants given baxdrostat under fed versus fasted conditions; food effect will be evaluated by comparing Cmax between participants under each condition.
  measure: Area under the curve [AUC] following administration of a tablet formulation of CIN-107 compared to AUC following administration of the oral solution.
  time frame: 0 to 21 days after dosing
  description: Area under the curve (AUC)0-∞ and AUC0-last will be determined for baxdrostat and any other measured metabolites for participants given each formulation of baxdrostat. Then relative bioavailability will be evaluated by comparing these AUC parameters between patients given the solution versus the tablet.
  measure: Time to maximum concentration [Tmax] of CIN-107 following administration of the tablet formulation under fed versus fasted conditions.
  time frame: 0 to 21 days after dosing
  description: Tmax will be determined for CIN-107 and any other measured metabolites for participants given baxdrostat under fed versus fasted conditions, and then food effect will be evaluated by comparing Tmax between participants under each condition.
  measure: AUC of CIN-107 following administration of the tablet formulation under fed versus fasted conditions.
  time frame: 0 to 21 days after dosing
  description: Area under the curve (AUC)0-∞ and AUC0-last will be determined for CIN-107 and any other measured metabolites for participants given baxdrostat under fed versus fasted conditions, and then food effect will be evaluated by comparing AUC between participants under each condition.
  measure: Tmax following administration of a tablet formulation of CIN-107 compared to Tmax following administration of the oral solution.
  time frame: 0 to 21 days after dosing
  description: Tmax will be determined for CIN-107 and any other measured metabolites for participants given each formulation of baxdrostat.
  measure: Angiotensin converting enzyme (ACE) levels following single doses of CIN-107.
  time frame: 0 to 21 days after dosing
  description: An exploratory assessment of the effect of CIN-107 on various measures associated with the Renin-Angiotensin-Aldosterone system including, but not limited to, angiotensin converting enzyme (ACE).
  arm group label: Baxdrostat oral solution
  arm group type: Experimental
  description: 5 mg CIN-107 oral solution in a fasted state
  arm group label: Baxdrostat tablet (fasted state)
  arm group type: Experimental
  description: 5 mg CIN-107 tablet(s) in a fasted state
  arm group label: Baxdrostat tablet (fed state)
  arm group type: Experimental
  description: 5 mg CIN-107 tablet(s) in a fed state (standard high fat meal)
  intervention type: Drug
  intervention name: baxdrostat (formerly CIN-107) oral solution
  description: 5 mg single dose of baxdrostat given as either a solution or tablet in either the fed or fasted state, depending on the arm of the study
  arm group label: Baxdrostat oral solution
  arm group label: Baxdrostat tablet (fasted state)
  arm group label: Baxdrostat tablet (fed state)
  other name: baxdrostat (formerly CIN-107) tablet
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 55 Years
  healthy volunteers: Accepts Healthy Volunteers
  last name: L Vrishabhendra, MD
  role: Principal Investigator
  affiliation: Medpace, Inc.
  facility: 
  country: United States
  url: https://filehosting-v2.pharmacm.com/api/Attachment/Download?tenantId=80217111&parentIdentifier=CIN-107-112&attachmentIdentifier=987d2c9f-2754-478e-bc37-f0963da20509&fileName=cin-107-112-report-synopsis_Redacted.pdf&versionIdentifier=
  description: Redacted CSR Synopsis
  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/