<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/NCT01701622</url>
  </required_header>
  <id_info>
    <org_study_id>2009-0186</org_study_id>
    <nct_id>NCT01701622</nct_id>
  </id_info>
  <brief_title>The Blood Pressure Effects of Febuxostat in Patients Previously Treated With Allopurinol: A Pilot Study</brief_title>
  <official_title>The Blood Pressure Effects of Febuxostat in Patients Previously Treated With Allopurinol: A Pilot Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Mississippi Medical Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Mississippi Medical Center</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Hyperuricemia (high uric acid level) has been correlated to hypertension (high blood&#xD;
      pressure) and overall cardiovascular disease risk in several studies. The relationship has&#xD;
      even been noted to be independent of metabolic syndrome and kidney function. It has been&#xD;
      repeatedly noted that hyperuricemia was an independent risk factor of death in those at high&#xD;
      cardiovascular disease risk. A recent review concluded that there is strong evidence that&#xD;
      hyperuricemia and gout are coupled with atherosclerosis and cardiovascular events.&#xD;
&#xD;
      Although this correlation of hypertension and hyperuricemia is known, there has only been one&#xD;
      published study that has evaluated if lowering the uric acid would reduce the blood pressure.&#xD;
      The authors concluded that in newly diagnosed hypertensive adolescents, allopurinol decreased&#xD;
      the blood pressure. Despite this, further evaluation of this therapeutic approach has not&#xD;
      been studied.&#xD;
&#xD;
      The hypothesis of this study is that febuxostat, a new xanthine oxidase inhibitor, has blood&#xD;
      pressure lowering effects superior to allopurinol in patients diagnosed with gout.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Screening and Recruitment&#xD;
&#xD;
        -  Identify and recruit 20 participants from the University of Mississippi Medical Center&#xD;
           General Internal Medicine/Hypertension and Family Medicine Clinics.&#xD;
&#xD;
        -  Participants must be currently taking allopurinol for the treatment of gout and be on a&#xD;
           stable dose of allopurinol for at least 2 months.&#xD;
&#xD;
        -  Any antihypertensive medications must be at stable doses for at least 2 months.&#xD;
&#xD;
        -  The identified patients will be invited to participate in the study.&#xD;
&#xD;
      Provide Consent&#xD;
&#xD;
        -  IRB approved comprehension survey will be administered to participants in determination&#xD;
           of competency to provide consent.&#xD;
&#xD;
        -  The &quot;Consent to Participate in Research&quot; information will be discussed with each&#xD;
           participant and consent acquired.&#xD;
&#xD;
        -  Materials can be taken by the potential participant to review and consent provided at a&#xD;
           later date.&#xD;
&#xD;
      Data collection&#xD;
&#xD;
        -  After consent is provided, study personnel will evaluate blood pressure (BP).&#xD;
&#xD;
        -  Participants will undergo 24-hour Ambulatory Blood Pressure Monitor (ABPM). The normal&#xD;
           fee for ABPM will be waived.&#xD;
&#xD;
        -  Participants will then discontinue allopurinol and initiate febuxostat at a comparable&#xD;
           dose. Febuxostat will be provided to all participants at no cost.&#xD;
&#xD;
             -  If receiving &lt; 300 mg allopurinol daily, will provide febuxostat 40 mg daily.&#xD;
&#xD;
             -  If receiving &gt; 300 mg allopurinol daily, will provide febuxostat 80 mg daily.&#xD;
&#xD;
        -  After at least 4 weeks of febuxostat, the participant will repeat 24-hour ABPM. The&#xD;
           normal fee for ABPM will be waived.&#xD;
&#xD;
        -  After completion of the febuxostat portion of the study, participants will receive a&#xD;
           compensation of $50 at the end of the study. Compensation will only be provided to those&#xD;
           who complete the entire study.&#xD;
&#xD;
      Results&#xD;
&#xD;
        -  Data collection will be added to participant's permanent medical records.&#xD;
&#xD;
        -  Results for individual participants will be discussed with the participant as well as&#xD;
           their primary care provider.&#xD;
&#xD;
        -  The decision to remain on febuxostat or resume allopurinol will lie with the primary&#xD;
           care provider.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    unable to enroll participants&#xD;
  </why_stopped>
  <start_date>January 2010</start_date>
  <completion_date type="Actual">October 2011</completion_date>
  <primary_completion_date type="Actual">October 2011</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>BP Differences While on Allopurinol and Febuxostat by Clinic Blood Pressure Readings and 24-hour Ambulatory Blood Pressure Readings</measure>
    <time_frame>4 to 5 weeks</time_frame>
    <description>The data collected will be analyzed and categorized according to age, race, gender, weight, height, 24-hour ABPM (24-hour systolic blood pressure (SBP)/diastolic blood pressure (DBP), trough SBP/DBP, and the mean nighttime SBP/SBP). Clinic systolic and diastolic BP and 24-hour AMBPs will be compared between the two treatments.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>If Patients With Hypertension Receive a Greater Reduction in Blood Pressure (BP) While on Febuxostat (Versus Allopurinol)</measure>
    <time_frame>Participants will be followed for an expected average of 4 to 5 weeks.</time_frame>
    <description>measured by mean 24-hour systolic blood pressure (SBP)/diastolic blood pressure (DBP), trough SBP/DBP, and mean nighttime SBP/SBP while on allopurionol and febuxostat.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">1</enrollment>
  <condition>Blood Pressure</condition>
  <condition>Gout</condition>
  <arm_group>
    <arm_group_label>Allopurinol, febuxostat</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients currently treated with allopurinol will be switched to febuxostat, and the blood pressure differences between the two arms will be compared.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>febuxostat</intervention_name>
    <description>If baseline allopurinol dose &lt; 300 mg daily, will initiate febuxostat 40 mg daily.&#xD;
If baseline allopurinol dose &gt; 300 mg daily, will initiate febuxostat 80 mg daily.&#xD;
Febuxostat is to be continued for 4 weeks, with blood pressure assessments by clinic and ambulatory blood pressure measurement at baseline and after 4 weeks.</description>
    <arm_group_label>Allopurinol, febuxostat</arm_group_label>
    <other_name>Uloric</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients currently treated at the University of Mississippi Medical Center General&#xD;
             Internal Medicine/Hypertension or Family Medicine Clinics.&#xD;
&#xD;
          -  Have a diagnosis of gout.&#xD;
&#xD;
          -  Taking allopurinol at a stable dose for at least 2 months.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Less than 18 years old.&#xD;
&#xD;
          -  Severe renal impairment defined as CrCl &lt;30 mL/min.&#xD;
&#xD;
          -  Previous diagnosis of severe hepatic impairment.&#xD;
&#xD;
          -  Currently taking azathioprine, mercaptopurine, or theophylline.&#xD;
&#xD;
          -  Pregnant, breastfeeding, or anticipating pregnancy or breastfeeding.&#xD;
&#xD;
          -  Arm circumference greater than 50 cm.&#xD;
&#xD;
          -  Change in antihypertensive medication within the previous 2 months.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Amber S Holdiness, PharmD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Mississippi Medical Center</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Mississippi Medical Center General Medicine/Hypertension and Family Medicine Clinics</name>
      <address>
        <city>Jackson</city>
        <state>Mississippi</state>
        <zip>39216</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>December 2017</verification_date>
  <study_first_submitted>January 27, 2010</study_first_submitted>
  <study_first_submitted_qc>October 3, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 5, 2012</study_first_posted>
  <results_first_submitted>November 9, 2012</results_first_submitted>
  <results_first_submitted_qc>February 8, 2013</results_first_submitted_qc>
  <results_first_posted type="Estimate">February 11, 2013</results_first_posted>
  <last_update_submitted>December 13, 2017</last_update_submitted>
  <last_update_submitted_qc>December 13, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">January 12, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Mississippi Medical Center</investigator_affiliation>
    <investigator_full_name>Deborah Minor</investigator_full_name>
    <investigator_title>Pharm D</investigator_title>
  </responsible_party>
  <keyword>Blood Pressure</keyword>
  <keyword>Gout</keyword>
  <keyword>allopurinol</keyword>
  <keyword>febuxostat</keyword>
  <keyword>uric acid</keyword>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Febuxostat</mesh_term>
  </intervention_browse>

  <clinical_results>

    <participant_flow>
      <recruitment_details>Recruitment - January 2010 - October 2011 Medical clinic</recruitment_details>
      <pre_assignment_details>No significant events or approaches to report.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>Allopurinol, Febuxostat</title>
          <description>Patients currently treated with allopurinol will be switched to febuxostat, and the blood pressure differences between the two arms will be compared.&#xD;
febuxostat : If baseline allopurinol dose &lt; 300 mg daily, will initiate febuxostat 40 mg daily.&#xD;
If baseline allopurinol dose &gt; 300 mg daily, will initiate febuxostat 80 mg daily.&#xD;
Febuxostat is to be continued for 4 weeks, with blood pressure assessments by clinic and ambulatory blood pressure measurement at baseline and after 4 weeks.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Allopurinol, Febuxostat</title>
          <description>Patients currently treated with allopurinol will be switched to febuxostat, and the blood pressure differences between the two arms will be compared.&#xD;
febuxostat : If baseline allopurinol dose &lt; 300 mg daily, will initiate febuxostat 40 mg daily.&#xD;
If baseline allopurinol dose &gt; 300 mg daily, will initiate febuxostat 80 mg daily.&#xD;
Febuxostat is to be continued for 4 weeks, with blood pressure assessments by clinic and ambulatory blood pressure measurement at baseline and after 4 weeks.</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="1"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>&lt;=18 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Between 18 and 65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="60"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>United States</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Blood pressure</title>
          <units>mm Hg</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <title>Diastolic Blood Pressure</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="79"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Systolic Blood Pressure</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="131"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>BP Differences While on Allopurinol and Febuxostat by Clinic Blood Pressure Readings and 24-hour Ambulatory Blood Pressure Readings</title>
        <description>The data collected will be analyzed and categorized according to age, race, gender, weight, height, 24-hour ABPM (24-hour systolic blood pressure (SBP)/diastolic blood pressure (DBP), trough SBP/DBP, and the mean nighttime SBP/SBP). Clinic systolic and diastolic BP and 24-hour AMBPs will be compared between the two treatments.</description>
        <time_frame>4 to 5 weeks</time_frame>
        <population>no analysis, as only one participant</population>
        <group_list>
          <group group_id="O1">
            <title>Allopurinol, Febuxostat</title>
            <description>Patients currently treated with allopurinol will be switched to febuxostat, and the blood pressure differences between the two arms will be compared.&#xD;
febuxostat: If baseline allopurinol dose &lt; 300 mg daily, will initiate febuxostat 40 mg daily.&#xD;
If baseline allopurinol dose &gt; 300 mg daily, will initiate febuxostat 80 mg daily.&#xD;
Febuxostat is to be continued for 4 weeks, with blood pressure assessments by clinic and ambulatory blood pressure measurement at baseline and after 4 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>BP Differences While on Allopurinol and Febuxostat by Clinic Blood Pressure Readings and 24-hour Ambulatory Blood Pressure Readings</title>
          <description>The data collected will be analyzed and categorized according to age, race, gender, weight, height, 24-hour ABPM (24-hour systolic blood pressure (SBP)/diastolic blood pressure (DBP), trough SBP/DBP, and the mean nighttime SBP/SBP). Clinic systolic and diastolic BP and 24-hour AMBPs will be compared between the two treatments.</description>
          <population>no analysis, as only one participant</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>If Patients With Hypertension Receive a Greater Reduction in Blood Pressure (BP) While on Febuxostat (Versus Allopurinol)</title>
        <description>measured by mean 24-hour systolic blood pressure (SBP)/diastolic blood pressure (DBP), trough SBP/DBP, and mean nighttime SBP/SBP while on allopurionol and febuxostat.</description>
        <time_frame>Participants will be followed for an expected average of 4 to 5 weeks.</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Allopurinol, Febuxostat</title>
            <description>Patients currently treated with allopurinol will be switched to febuxostat, and the blood pressure differences between the two arms will be compared.&#xD;
febuxostat: If baseline allopurinol dose &lt; 300 mg daily, will initiate febuxostat 40 mg daily.&#xD;
If baseline allopurinol dose &gt; 300 mg daily, will initiate febuxostat 80 mg daily.&#xD;
Febuxostat is to be continued for 4 weeks, with blood pressure assessments by clinic and ambulatory blood pressure measurement at baseline and after 4 weeks.&#xD;
as reported earlier (2013), no statistical analysis because of no study participate completion</description>
          </group>
        </group_list>
        <measure>
          <title>If Patients With Hypertension Receive a Greater Reduction in Blood Pressure (BP) While on Febuxostat (Versus Allopurinol)</title>
          <description>measured by mean 24-hour systolic blood pressure (SBP)/diastolic blood pressure (DBP), trough SBP/DBP, and mean nighttime SBP/SBP while on allopurionol and febuxostat.</description>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>adverse event data collected over a total period of 4 weeks</time_frame>
      <desc>Spontaneously report adverse events</desc>
      <group_list>
        <group group_id="E1">
          <title>Febuxostat</title>
          <description>Febuxostat group. The primary outcome of the study is the 24 hour ABPM differences while participants were taking allopurinol compared to taking febuxostat.</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="1"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="1"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>All Principal Investigators ARE employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <limitations_and_caveats>Early termination leading to no subjects analyzed</limitations_and_caveats>
    <point_of_contact>
      <name_or_title>Debbie Minor</name_or_title>
      <organization>University of Mississippi Medical Center</organization>
      <phone>601-984-6888</phone>
      <email>DMinor@umc.edu</email>
    </point_of_contact>
  </clinical_results>
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT01701622
org study id: 2009-0186
nct id: NCT01701622
lead sponsor: 
has dmc: No
Hyperuricemia (high uric acid level) has been correlated to hypertension (high blood
      pressure) and overall cardiovascular disease risk in several studies. The relationship has
      even been noted to be independent of metabolic syndrome and kidney function. It has been
      repeatedly noted that hyperuricemia was an independent risk factor of death in those at high
      cardiovascular disease risk. A recent review concluded that there is strong evidence that
      hyperuricemia and gout are coupled with atherosclerosis and cardiovascular events.

      Although this correlation of hypertension and hyperuricemia is known, there has only been one
      published study that has evaluated if lowering the uric acid would reduce the blood pressure.
      The authors concluded that in newly diagnosed hypertensive adolescents, allopurinol decreased
      the blood pressure. Despite this, further evaluation of this therapeutic approach has not
      been studied.

      The hypothesis of this study is that febuxostat, a new xanthine oxidase inhibitor, has blood
      pressure lowering effects superior to allopurinol in patients diagnosed with gout.
Screening and Recruitment

        -  Identify and recruit 20 participants from the University of Mississippi Medical Center
           General Internal Medicine/Hypertension and Family Medicine Clinics.

        -  Participants must be currently taking allopurinol for the treatment of gout and be on a
           stable dose of allopurinol for at least 2 months.

        -  Any antihypertensive medications must be at stable doses for at least 2 months.

        -  The identified patients will be invited to participate in the study.

      Provide Consent

        -  IRB approved comprehension survey will be administered to participants in determination
           of competency to provide consent.

        -  The "Consent to Participate in Research" information will be discussed with each
           participant and consent acquired.

        -  Materials can be taken by the potential participant to review and consent provided at a
           later date.

      Data collection

        -  After consent is provided, study personnel will evaluate blood pressure (BP).

        -  Participants will undergo 24-hour Ambulatory Blood Pressure Monitor (ABPM). The normal
           fee for ABPM will be waived.

        -  Participants will then discontinue allopurinol and initiate febuxostat at a comparable
           dose. Febuxostat will be provided to all participants at no cost.

             -  If receiving < 300 mg allopurinol daily, will provide febuxostat 40 mg daily.

             -  If receiving > 300 mg allopurinol daily, will provide febuxostat 80 mg daily.

        -  After at least 4 weeks of febuxostat, the participant will repeat 24-hour ABPM. The
           normal fee for ABPM will be waived.

        -  After completion of the febuxostat portion of the study, participants will receive a
           compensation of $50 at the end of the study. Compensation will only be provided to those
           who complete the entire study.

      Results

        -  Data collection will be added to participant's permanent medical records.

        -  Results for individual participants will be discussed with the participant as well as
           their primary care provider.

        -  The decision to remain on febuxostat or resume allopurinol will lie with the primary
           care provider.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: BP Differences While on Allopurinol and Febuxostat by Clinic Blood Pressure Readings and 24-hour Ambulatory Blood Pressure Readings
time frame: 4 to 5 weeks
description: The data collected will be analyzed and categorized according to age, race, gender, weight, height, 24-hour ABPM (24-hour systolic blood pressure (SBP)/diastolic blood pressure (DBP), trough SBP/DBP, and the mean nighttime SBP/SBP). Clinic systolic and diastolic BP and 24-hour AMBPs will be compared between the two treatments.
measure: If Patients With Hypertension Receive a Greater Reduction in Blood Pressure (BP) While on Febuxostat (Versus Allopurinol)
time frame: Participants will be followed for an expected average of 4 to 5 weeks.
description: measured by mean 24-hour systolic blood pressure (SBP)/diastolic blood pressure (DBP), trough SBP/DBP, and mean nighttime SBP/SBP while on allopurionol and febuxostat.
arm group label: Allopurinol, febuxostat
arm group type: Experimental
description: Patients currently treated with allopurinol will be switched to febuxostat, and the blood pressure differences between the two arms will be compared.
intervention type: Drug
intervention name: febuxostat
description: If baseline allopurinol dose < 300 mg daily, will initiate febuxostat 40 mg daily.
If baseline allopurinol dose > 300 mg daily, will initiate febuxostat 80 mg daily.
Febuxostat is to be continued for 4 weeks, with blood pressure assessments by clinic and ambulatory blood pressure measurement at baseline and after 4 weeks.
arm group label: Allopurinol, febuxostat
other name: Uloric
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: No
last name: Amber S Holdiness, PharmD
role: Principal Investigator
affiliation: University of Mississippi Medical Center
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: University of Mississippi Medical Center
investigator full name: Deborah Minor
investigator title: Pharm D
mesh term: Febuxostat
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
limitations and caveats: Early termination leading to no subjects analyzed
point of contact: 