<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/NCT02252406</url>
  </required_header>
  <id_info>
    <org_study_id>WIRB20141202</org_study_id>
    <nct_id>NCT02252406</nct_id>
  </id_info>
  <brief_title>Impact of Ranolazine in Blood Markers in Women With Angina and Metabolic Syndrome</brief_title>
  <acronym>IRMA</acronym>
  <official_title>Impact of Ranolazine on Inflammatory, Thrombogenic, Lipogenic, Biomarkers in Women With Angina and Metabolic Syndrome.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Florida</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Florida</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>
      The purpose of this study is to determine the effects of ranolazine on different markers of&#xD;
      cardiometabolic disease in women with stable angina.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Evaluate the ability of ranolazine to favorably modify thrombogenic, inflammatory, lipogenic,&#xD;
      oxidative stress and hormonal biomarkers in a relatively short period of time in a group of&#xD;
      ethnically diverse women with chronic stable angina and metabolic syndrome.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>September 2015</start_date>
  <completion_date type="Actual">May 17, 2019</completion_date>
  <primary_completion_date type="Actual">December 17, 2018</primary_completion_date>
  <phase>Phase 4</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>Impact of Ranolazine on Hemoglobin A1C</measure>
    <time_frame>Change from baseline to 24 weeks</time_frame>
    <description>Will evaluate the impact of ranolazine in HgbA1C in women with Metabolic Syndrome (MBS)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Impact of Ranolazine on HDL-C Levels in Subjects</measure>
    <time_frame>Change from Baseline to 24 weeks</time_frame>
    <description>Will evaluate the impact of ranolazine in HDL-C levels in women with metabolic syndrome</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">33</enrollment>
  <condition>Stable Angina</condition>
  <condition>Metabolic Syndrome</condition>
  <arm_group>
    <arm_group_label>Ranolazine</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Ranolazine would start with 500 mg BID and be force titrated to 1 gram po BID after 3 weeks. Down titration would only be allowed for side effects. This would be on top of all standard medical therapy.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Placebo arm would start with 500 mg matching placebo tablet BID and be force titrated to 1 gram matching placebo tablet twice a day after 3 weeks. Down titration would only be allowed for side effects (if reported). This would be on top of all standard medical therapy.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Ranolazine</intervention_name>
    <description>Ranolazine 500 mg from baseline to week 3 and 1000 mg thereafter until week 24</description>
    <arm_group_label>Ranolazine</arm_group_label>
    <other_name>Ranexa</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Matching placebo tablets daily for 24 weeks.</description>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients with chronic stable angina (&gt; 3 months) on evidence based adequate therapy&#xD;
&#xD;
          -  Evidence of stable coronary artery disease by any of these:&#xD;
&#xD;
          -  MI, PCI or CABG &gt; 30 days prior to enrollment or&#xD;
&#xD;
          -  Angiography showing &gt; 50% stenosis in major vessel, branch or bypass graft &gt; 30 days&#xD;
             of enrollment or&#xD;
&#xD;
          -  Abnormal stress MPI nuclear study, or DBA stress echo where the decision has been to&#xD;
             treat medically and where angina has remained stable for &gt;= 3 months&#xD;
&#xD;
          -  Evidence of the Metabolic Syndrome: As defined by ATP III criteria i.e 3/5 of&#xD;
             following Abdominal circumference F &gt; 88 cm (35 in), M &gt; 102 cm (40 in)&#xD;
             Hypertriglyceridemia ≥ 150 mg/dl HDL F &lt; 50 mg/dl M &lt; 40 mg/dl Blood Pressure ≥130/85&#xD;
             Fasting Glucose ≥100 mg/dl For reproductive age women, a negative urine pregnancy test&#xD;
             is required if all other inclusion criteria are met.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Exclusion of patients with contraindications to use of RANEXA, including patients on&#xD;
             CYP3A4 inducers/potent inhibitors, and patients with liver cirrhosis.&#xD;
&#xD;
          -  Exclusion of Patients with CrCl &lt; 30 mL/min&#xD;
&#xD;
          -  Limit dose of RANEXA to 500mg BID in patients on concurrent diltiazem/ verapamil&#xD;
&#xD;
          -  Limit concurrent simvastatin to 20 mg/day&#xD;
&#xD;
          -  Limit concurrent metformin to 1700 mg/day Additional Exclusion&#xD;
&#xD;
          -  Patients with variable -inconsistent symptoms&#xD;
&#xD;
          -  Patients with unstable coronary artery disease or revascularization within 30 days of&#xD;
             enrollment.&#xD;
&#xD;
          -  Patients who have known severe liver disease.&#xD;
&#xD;
          -  Patients already receiving maximal ranolazine therapy for more than 4 weeks&#xD;
&#xD;
          -  Presence of diabetes (AIC≥ 6.5 and /or on insulin therapy or anti-diabetic medication&#xD;
             other than metformin) unstable hypothyroidism, active infection, active cancer (or&#xD;
             ongoing chemotherapy and/or radiation within a year who are not on remission) and/or&#xD;
             recent major surgery or illness.&#xD;
&#xD;
          -  Patients with any contraindication to ranolazine see above&#xD;
&#xD;
          -  Women of reproductive age are excluded if they are planning to become pregnant in the&#xD;
             next 6 -12 months after randomization.&#xD;
&#xD;
          -  Patients who are pregnant or lactating&#xD;
&#xD;
          -  Documented allergic reaction to ranolazine in the past.&#xD;
&#xD;
          -  Unexplained prolongation of the QTc &gt; 500 milliseconds.&#xD;
&#xD;
          -  Current or planned co-administration of moderate CYP3A inhibitors (eg, diltiazem,&#xD;
             verapamil, aprepitant, erythromycin, fluconazole, and grapefruit juice or&#xD;
             grapefruit-containing products) is not a full contraindication, if meet inclusion&#xD;
             criteria otherwise, these patients could be accepted in trial but dose will be limited&#xD;
             to 500 mg BID as stated previously.&#xD;
&#xD;
          -  Current or planned co-administration of strong CYP3A inhibitors (eg, ketoconazole,&#xD;
             itraconazole, clarithromycin, nefazodone, nelfinavir, ritonavir, indinavir, and&#xD;
             saquinavir) OR strong CYP3A inducers (eg, rifampin, rifabutin, rifapentine,&#xD;
             phenobarbital, phenytoin,carbamazepine, and St. John's Wort) is a contraindication.&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>30 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Gladys P Velarde, MD, FACC</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Florida</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Florida</name>
      <address>
        <city>Jacksonville</city>
        <state>Florida</state>
        <zip>32209</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>March 2020</verification_date>
  <study_first_submitted>August 11, 2014</study_first_submitted>
  <study_first_submitted_qc>September 25, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 30, 2014</study_first_posted>
  <results_first_submitted>February 7, 2020</results_first_submitted>
  <results_first_submitted_qc>March 27, 2020</results_first_submitted_qc>
  <results_first_posted type="Actual">April 10, 2020</results_first_posted>
  <last_update_submitted>March 27, 2020</last_update_submitted>
  <last_update_submitted_qc>March 27, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">April 10, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Stable Angina</keyword>
  <keyword>Metabolic Syndrome</keyword>
  <keyword>Women</keyword>
  <keyword>Biomarkers</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Angina Pectoris</mesh_term>
    <mesh_term>Angina, Stable</mesh_term>
    <mesh_term>Metabolic Syndrome</mesh_term>
    <mesh_term>Syndrome</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Ranolazine</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol and Statistical Analysis Plan</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>May 25, 2017</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/06/NCT02252406/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <recruitment_details>Recruitment period: 7/21/14 - 7/2/18 Location: UF Jacksonville Outpatient Cardiology clinic</recruitment_details>
      <group_list>
        <group group_id="P1">
          <title>Ranolazine</title>
          <description>Ranolazine would start with 500 mg BID and be force titrated to 1 gram po BID after 3 weeks. Down titration would only be allowed for side effects. This would be on top of all standard medical therapy.&#xD;
Ranolazine: Ranolazine 500 mg from baseline to week 3&#xD;
Ranolazine: Ranolazine 1000mg daily at week 3 until weeks 24.</description>
        </group>
        <group group_id="P2">
          <title>Placebo</title>
          <description>Placebo arm would start with 500 mg matching placebo tablet BID and be force titrated to 1 gram matching placebo tablet twice a day after 3 weeks. Down titration would only be allowed for side effects (if reported). This would be on top of all standard medical therapy.&#xD;
Placebo: Matching placebo tablets daily for 24 weeks.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Starting Dose Ranolazine 500 mg BID</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="16"/>
                <participants group_id="P2" count="17"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="12"/>
                <participants group_id="P2" count="14"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="4"/>
                <participants group_id="P2" count="3"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
                <participants group_id="P2" count="3"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Adverse Event</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
        <period>
          <title>Titrated to Ranolazine 1000mg BID</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="12"/>
                <participants group_id="P2" count="14"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="9"/>
                <participants group_id="P2" count="13"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="3"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Adverse Event</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Ranolazine</title>
          <description>Ranolazine would start with 500 mg BID and be force titrated to 1 gram po BID after 3 weeks. Down titration would only be allowed for side effects. This would be on top of all standard medical therapy.&#xD;
Ranolazine: Ranolazine 500 mg from baseline to week 3&#xD;
Ranolazine: Ranolazine 1000mg daily at week 3 until weeks 24.</description>
        </group>
        <group group_id="B2">
          <title>Placebo</title>
          <description>Placebo arm would start with 500 mg matching placebo tablet BID and be force titrated to 1 gram matching placebo tablet twice a day after 3 weeks. Down titration would only be allowed for side effects (if reported). This would be on top of all standard medical therapy.&#xD;
Placebo: Matching placebo tablets daily for 24 weeks.</description>
        </group>
        <group group_id="B3">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="16"/>
            <count group_id="B2" value="17"/>
            <count group_id="B3" value="33"/>
          </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 group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Between 18 and 65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="10"/>
                    <measurement group_id="B2" value="10"/>
                    <measurement group_id="B3" value="20"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="6"/>
                    <measurement group_id="B2" value="7"/>
                    <measurement group_id="B3" value="13"/>
                  </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="16"/>
                    <measurement group_id="B2" value="17"/>
                    <measurement group_id="B3" value="33"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="4"/>
                    <measurement group_id="B3" value="6"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="14"/>
                    <measurement group_id="B2" value="12"/>
                    <measurement group_id="B3" value="26"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </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="16"/>
                    <measurement group_id="B2" value="17"/>
                    <measurement group_id="B3" value="33"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Impact of Ranolazine on Hemoglobin A1C</title>
        <description>Will evaluate the impact of ranolazine in HgbA1C in women with Metabolic Syndrome (MBS)</description>
        <time_frame>Change from baseline to 24 weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Ranolazine Treated</title>
            <description>We looked women randomized by table randomization to ranolazine that successfully titrated to maximum dose of tested drug (1,000 mg bid)</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>We looked women randomized by table randomization to placebo that successfully titrated to maximum dose of placebo drug</description>
          </group>
        </group_list>
        <measure>
          <title>Impact of Ranolazine on Hemoglobin A1C</title>
          <description>Will evaluate the impact of ranolazine in HgbA1C in women with Metabolic Syndrome (MBS)</description>
          <units>percent change</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="9"/>
                <count group_id="O2" value="13"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-5" spread="6.2"/>
                    <measurement group_id="O2" value="2.6" spread="9.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Impact of Ranolazine on HDL-C Levels in Subjects</title>
        <description>Will evaluate the impact of ranolazine in HDL-C levels in women with metabolic syndrome</description>
        <time_frame>Change from Baseline to 24 weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Ranolazine Treated</title>
            <description>We looked women randomized by table randomization to ranolazine that successfully titrated to maximum dose of tested drug (1,000 mg bid)</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>We looked women randomized by table randomization to placebo that successfully titrated to maximum dose of placebo drug</description>
          </group>
        </group_list>
        <measure>
          <title>Impact of Ranolazine on HDL-C Levels in Subjects</title>
          <description>Will evaluate the impact of ranolazine in HDL-C levels in women with metabolic syndrome</description>
          <units>percentage of change in HDL</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="9"/>
                <count group_id="O2" value="13"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6.6" spread="15.7"/>
                    <measurement group_id="O2" value="6.5" spread="46.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Patients were followed for 24 weeks</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Ranolazine Treated</title>
          <description>Ranolazine would start with 500 mg BID and be force titrated to 1 gram po BID after 3 weeks. Down titration would only be allowed for side effects. This would be on top of all standard medical therapy</description>
        </group>
        <group group_id="E2">
          <title>Placebo</title>
          <description>Placebo arm would start with 500 mg matching placebo tablet BID and be force titrated to 1 gram matching placebo tablet twice a day after 3 weeks. Down titration would only be allowed for side effects (if reported). This would be on top of all standard medical therapy.</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="16"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="17"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="17"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</frequency_threshold>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="16"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="17"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>upset stomach</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="16"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="17"/>
              </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>
    <point_of_contact>
      <name_or_title>Gladys Velarde, MD</name_or_title>
      <organization>University of Florida, Jacksonville</organization>
      <phone>904-244-2060</phone>
      <email>gladys.velarde@jax.ufl.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/NCT02252406
org study id: WIRB20141202
nct id: NCT02252406
lead sponsor: 
has dmc: Yes
is fda regulated drug: Yes
is fda regulated device: No
The purpose of this study is to determine the effects of ranolazine on different markers of
      cardiometabolic disease in women with stable angina.
Evaluate the ability of ranolazine to favorably modify thrombogenic, inflammatory, lipogenic,
      oxidative stress and hormonal biomarkers in a relatively short period of time in a group of
      ethnically diverse women with chronic stable angina and metabolic syndrome.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Impact of Ranolazine on Hemoglobin A1C
time frame: Change from baseline to 24 weeks
description: Will evaluate the impact of ranolazine in HgbA1C in women with Metabolic Syndrome (MBS)
measure: Impact of Ranolazine on HDL-C Levels in Subjects
time frame: Change from Baseline to 24 weeks
description: Will evaluate the impact of ranolazine in HDL-C levels in women with metabolic syndrome
arm group label: Ranolazine
arm group type: Experimental
description: Ranolazine would start with 500 mg BID and be force titrated to 1 gram po BID after 3 weeks. Down titration would only be allowed for side effects. This would be on top of all standard medical therapy.
arm group label: Placebo
arm group type: Placebo Comparator
description: Placebo arm would start with 500 mg matching placebo tablet BID and be force titrated to 1 gram matching placebo tablet twice a day after 3 weeks. Down titration would only be allowed for side effects (if reported). This would be on top of all standard medical therapy.
intervention type: Drug
intervention name: Ranolazine
description: Ranolazine 500 mg from baseline to week 3 and 1000 mg thereafter until week 24
arm group label: Ranolazine
other name: Ranexa
intervention type: Other
intervention name: Placebo
description: Matching placebo tablets daily for 24 weeks.
arm group label: Placebo
criteria: 
gender: Female
minimum age: 30 Years
maximum age: 75 Years
healthy volunteers: No
last name: Gladys P Velarde, MD, FACC
role: Principal Investigator
affiliation: University of Florida
facility: 
country: United States
responsible party type: Sponsor
mesh term: Angina Pectoris
mesh term: Angina, Stable
mesh term: Metabolic Syndrome
mesh term: Syndrome
mesh term: Ranolazine
sharing ipd: No
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 