<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/NCT01721967</url>
  </required_header>
  <id_info>
    <org_study_id>Pro00039302</org_study_id>
    <secondary_id>3938381</secondary_id>
    <nct_id>NCT01721967</nct_id>
  </id_info>
  <brief_title>Ranolazine for the Treatment of Chest Pain in HCM Patients</brief_title>
  <acronym>RHYME</acronym>
  <official_title>Ranolazine for the Treatment of Angina in Hypertrophic Cardiomyopathy Investigation</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Duke University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Gilead Sciences</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Duke University</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of RHYME is to evaluate the safety and efficacy of ranolazine in Hypertrophic&#xD;
      Cardiomypathy patients with chest pain or dyspnea despite treatment with standard medical&#xD;
      therapy. This is a small, pilot, open-label (non-randomized) study of an approved drug for&#xD;
      the treatment of angina in a novel patient population (adult patient population with&#xD;
      hypertrophic cardiomyopathy).&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>November 2012</start_date>
  <completion_date type="Actual">May 2016</completion_date>
  <primary_completion_date type="Actual">November 2015</primary_completion_date>
  <phase>Phase 4</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>Supportive Care</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>QT Interval</measure>
    <time_frame>60 Days</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of Adverse Events Considered Probably or Possibly Related to Study Drug</measure>
    <time_frame>60 Days</time_frame>
    <description>Number of events that are considered probably or possibly related to study drug.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Drug Tolerability</measure>
    <time_frame>60 days</time_frame>
    <description>Total number of patients that tolerated 1,000mg BID dose and 500 mg BID dose</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Improvement in Number of Episodes of Angina Per Week</measure>
    <time_frame>Baseline and 60 Days post treatment</time_frame>
    <description>Efficacy of ranolazine in HCM patients with respect to improvements in angina frequency (number of episodes of angina per week).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Seattle Angina Questionnaire (SAQ)</measure>
    <time_frame>60 Days post treatment</time_frame>
    <description>The Seattle Angina Questionnaire (SAQ) is a self-administered, 19-item questionnaire, a cardiac disease-related quality-of-life measure. The SAQ is well validated and sensitive to clinical changes. It has five subscales: physical limitation, angina stability, angina frequency, treatment satisfaction, and disease perception. The possible range of scores for each of the five subscales is 0 to 100, with higher scores indicating better quality of life.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Kansas City Cardiomyopathy Questionnaire (KCCQ)</measure>
    <time_frame>60 days post treatement</time_frame>
    <description>Kansas City Cardiomyopathy Questionnaire (KCCQ) (scores range from 0 to 100 with higher scores representative of a higher quality of life; clinically important changes are considered &gt; 10 points and &gt;5 points, respectively, as previously established</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">14</enrollment>
  <condition>Hypertrophic Cardiomyopathy</condition>
  <arm_group>
    <arm_group_label>Ranolazine</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Ranolazine, 500 mg for 60 days</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Ranolazine</intervention_name>
    <arm_group_label>Ranolazine</arm_group_label>
    <other_name>Ranexa</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age 18 years or older&#xD;
&#xD;
          -  Left Ventricle wall thickness &gt;/= 15mm in the absence of other condition causing&#xD;
             hypertrophy&#xD;
&#xD;
          -  Baseline Angina/Shortness of Breath Frequency of &gt; 2 episodes per week&#xD;
&#xD;
          -  Willing to provide informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Severe stenotic valvular disease&#xD;
&#xD;
          -  Severe valvular regurgitation except mitral regurgitation due to systolic anterior&#xD;
             motion&#xD;
&#xD;
          -  Significant (&gt;60% stenosis) coronary artery disease&#xD;
&#xD;
          -  Acute coronary syndrome within 30 days&#xD;
&#xD;
          -  Severe heart failure defined as LV systolic dysfunction with Ejection Fraction &lt;40% or&#xD;
             NYHA class 4 symptoms&#xD;
&#xD;
          -  Severe renal impairment (glomerular filtration rate, &lt;30 mL/min/1.73 m2)&#xD;
&#xD;
          -  Moderate-severe hepatic impairment (Child-Pugh classes B and C)&#xD;
&#xD;
          -  Hospitalization for cardiac reason within 3 months of enrollment&#xD;
&#xD;
          -  Anticipated changes to treatment of HCM within study period, including medications,&#xD;
             device implantation, or septal reduction therapies&#xD;
&#xD;
          -  Concomitant use of ketoconazole, macrolide antibiotics, and HIV protease inhibitors&#xD;
&#xD;
          -  Active myocarditis, pericarditis, or restrictive cardiomyopathy&#xD;
&#xD;
          -  Non-cardiac terminal illness with expected survival less than 6 months&#xD;
&#xD;
          -  Women who are of childbearing potential&#xD;
&#xD;
          -  Inability to perform or adhere to study protocol&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Duke University Medical Center</name>
      <address>
        <city>Durham</city>
        <state>North Carolina</state>
        <zip>27710</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>January 2017</verification_date>
  <study_first_submitted>November 2, 2012</study_first_submitted>
  <study_first_submitted_qc>November 2, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 6, 2012</study_first_posted>
  <results_first_submitted>November 4, 2016</results_first_submitted>
  <results_first_submitted_qc>November 21, 2016</results_first_submitted_qc>
  <results_first_posted type="Estimate">January 18, 2017</results_first_posted>
  <last_update_submitted>January 19, 2017</last_update_submitted>
  <last_update_submitted_qc>January 19, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">March 3, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>chest pain</keyword>
  <keyword>dyspnea</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Cardiomyopathies</mesh_term>
    <mesh_term>Cardiomyopathy, Hypertrophic</mesh_term>
    <mesh_term>Hypertrophy</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Ranolazine</mesh_term>
  </intervention_browse>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Ranolazine</title>
          <description>Ranolazine, 500 mg for 60 days</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="14"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="11"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="3"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Ranolazine</title>
          <description>Ranolazine, 500 mg for 60 days</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="14"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <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="63.2" spread="9.0"/>
                  </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="8"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Seattle Angina Questionnaire</title>
          <description>The SAQ is a self-report instrument with 19 items that yields five subscale scores: physical limitation, angina stability, angina frequency, treatment satisfaction, and disease perception. The possible range of scores for each of the five subscales is 0 to 100, with higher scores indicating better quality of life.</description>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <title>Physical limitation</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="49.6" spread="18.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Anginal stability</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="45.5" spread="27.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Anginal frequency</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="65.5" spread="13.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Treatment satisfaction</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="85.2" spread="12.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Quality of life</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="40.9" spread="24.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Kansas City Cardiomyopathy Questionnaire (KCCQ)</title>
          <description>Similarly, the Kansas City Cardiomyopathy Questionnaire (KCCQ) is a new, self-administered, 23-item questionnaire developed to provide a better description of health-related quality of life in patients with heart failure. It quantifies, in a disease-specific fashion, physical limitation, symptoms (frequency, severity and recent change over time), quality of life, social interference and self-efficacy. All categories of questions are scored from 0-100, with higher number indicating better health.</description>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <title>Physical limitation</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="61.7" spread="20.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Symptom stability</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="43.2" spread="16.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Symptom frequency</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="56.4" spread="20.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Symptom burden</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="55.3" spread="29.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Total symptom score</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="55.9" spread="24.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Self-efficacy</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="78.4" spread="21.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Quality of life</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="39.4" spread="26.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Social limitation</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="46.0" spread="31.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Overall summary</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="51.2" spread="22.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Clinical summary</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="58.8" spread="20.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>QT Interval</title>
        <time_frame>60 Days</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Ranolazine</title>
            <description>Ranolazine, 500 mg for 60 days</description>
          </group>
        </group_list>
        <measure>
          <title>QT Interval</title>
          <units>msec</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="11"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="462.8" spread="27.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Number of Adverse Events Considered Probably or Possibly Related to Study Drug</title>
        <description>Number of events that are considered probably or possibly related to study drug.</description>
        <time_frame>60 Days</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Ranolazine</title>
            <description>Ranolazine, 500 mg for 60 days</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Adverse Events Considered Probably or Possibly Related to Study Drug</title>
          <description>Number of events that are considered probably or possibly related to study drug.</description>
          <units>adverse event</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="14"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Drug Tolerability</title>
        <description>Total number of patients that tolerated 1,000mg BID dose and 500 mg BID dose</description>
        <time_frame>60 days</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Ranolazine</title>
            <description>Ranolazine, 500 mg for 60 days</description>
          </group>
        </group_list>
        <measure>
          <title>Drug Tolerability</title>
          <description>Total number of patients that tolerated 1,000mg BID dose and 500 mg BID dose</description>
          <units>participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="14"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>1000 mg BID</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>500 mg BID</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Improvement in Number of Episodes of Angina Per Week</title>
        <description>Efficacy of ranolazine in HCM patients with respect to improvements in angina frequency (number of episodes of angina per week).</description>
        <time_frame>Baseline and 60 Days post treatment</time_frame>
        <population>episodes of angina per week was not collected</population>
        <group_list>
          <group group_id="O1">
            <title>Ranolazine</title>
            <description>Ranolazine, 500 mg for 60 days</description>
          </group>
        </group_list>
        <measure>
          <title>Improvement in Number of Episodes of Angina Per Week</title>
          <description>Efficacy of ranolazine in HCM patients with respect to improvements in angina frequency (number of episodes of angina per week).</description>
          <population>episodes of angina per week was not collected</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>Seattle Angina Questionnaire (SAQ)</title>
        <description>The Seattle Angina Questionnaire (SAQ) is a self-administered, 19-item questionnaire, a cardiac disease-related quality-of-life measure. The SAQ is well validated and sensitive to clinical changes. It has five subscales: physical limitation, angina stability, angina frequency, treatment satisfaction, and disease perception. The possible range of scores for each of the five subscales is 0 to 100, with higher scores indicating better quality of life.</description>
        <time_frame>60 Days post treatment</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Ranolazine</title>
            <description>Ranolazine, 500 mg for 60 days</description>
          </group>
        </group_list>
        <measure>
          <title>Seattle Angina Questionnaire (SAQ)</title>
          <description>The Seattle Angina Questionnaire (SAQ) is a self-administered, 19-item questionnaire, a cardiac disease-related quality-of-life measure. The SAQ is well validated and sensitive to clinical changes. It has five subscales: physical limitation, angina stability, angina frequency, treatment satisfaction, and disease perception. The possible range of scores for each of the five subscales is 0 to 100, with higher scores indicating better quality of life.</description>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="11"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Physical limitation</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="61.4" spread="18"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Anginal stability</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="90.0" spread="21.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Anginal frequency</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="86.0" spread="12.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Treatment satisfaction</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="90.6" spread="11.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Quality of life</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="70.8" spread="11.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Kansas City Cardiomyopathy Questionnaire (KCCQ)</title>
        <description>Kansas City Cardiomyopathy Questionnaire (KCCQ) (scores range from 0 to 100 with higher scores representative of a higher quality of life; clinically important changes are considered &gt; 10 points and &gt;5 points, respectively, as previously established</description>
        <time_frame>60 days post treatement</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Ranolazine</title>
            <description>Ranolazine, 500 mg for 60 days</description>
          </group>
        </group_list>
        <measure>
          <title>Kansas City Cardiomyopathy Questionnaire (KCCQ)</title>
          <description>Kansas City Cardiomyopathy Questionnaire (KCCQ) (scores range from 0 to 100 with higher scores representative of a higher quality of life; clinically important changes are considered &gt; 10 points and &gt;5 points, respectively, as previously established</description>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="11"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Physical limitation</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="72" spread="20.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Symptom stability</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="72.7" spread="26.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Symptom frequency</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="72.2" spread="20"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Symptom burden</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="75" spread="24.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Total symptom score</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="73.6" spread="21.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Self-efficacy</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="85.2" spread="14.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Quality of life</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="65.2" spread="25.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Social limitation</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="66.1" spread="31.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Overall summary</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="69.8" spread="23.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Clinical summary</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="74" spread="20.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <group_list>
        <group group_id="E1">
          <title>Ranolazine</title>
          <description>Ranolazine, 500 mg for 60 days</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="14"/>
              </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="2" subjects_at_risk="14"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>dizziness</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="14"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Leg Weakness</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="14"/>
              </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>Andrew Wang, MD</name_or_title>
      <organization>Duke University Health System</organization>
      <phone>919-681-6197</phone>
      <email>a.wang@duke.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/NCT01721967
org study id: Pro00039302
secondary id: 3938381
nct id: NCT01721967
lead sponsor: 
collaborator: 
has dmc: Yes
The purpose of RHYME is to evaluate the safety and efficacy of ranolazine in Hypertrophic
      Cardiomypathy patients with chest pain or dyspnea despite treatment with standard medical
      therapy. This is a small, pilot, open-label (non-randomized) study of an approved drug for
      the treatment of angina in a novel patient population (adult patient population with
      hypertrophic cardiomyopathy).
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Supportive Care
masking: None (Open Label)
measure: QT Interval
time frame: 60 Days
measure: Number of Adverse Events Considered Probably or Possibly Related to Study Drug
time frame: 60 Days
description: Number of events that are considered probably or possibly related to study drug.
measure: Drug Tolerability
time frame: 60 days
description: Total number of patients that tolerated 1,000mg BID dose and 500 mg BID dose
measure: Improvement in Number of Episodes of Angina Per Week
time frame: Baseline and 60 Days post treatment
description: Efficacy of ranolazine in HCM patients with respect to improvements in angina frequency (number of episodes of angina per week).
measure: Seattle Angina Questionnaire (SAQ)
time frame: 60 Days post treatment
description: The Seattle Angina Questionnaire (SAQ) is a self-administered, 19-item questionnaire, a cardiac disease-related quality-of-life measure. The SAQ is well validated and sensitive to clinical changes. It has five subscales: physical limitation, angina stability, angina frequency, treatment satisfaction, and disease perception. The possible range of scores for each of the five subscales is 0 to 100, with higher scores indicating better quality of life.
measure: Kansas City Cardiomyopathy Questionnaire (KCCQ)
time frame: 60 days post treatement
description: Kansas City Cardiomyopathy Questionnaire (KCCQ) (scores range from 0 to 100 with higher scores representative of a higher quality of life; clinically important changes are considered > 10 points and >5 points, respectively, as previously established
arm group label: Ranolazine
arm group type: Experimental
description: Ranolazine, 500 mg for 60 days
intervention type: Drug
intervention name: Ranolazine
arm group label: Ranolazine
other name: Ranexa
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
country: United States
responsible party type: Sponsor
mesh term: Cardiomyopathies
mesh term: Cardiomyopathy, Hypertrophic
mesh term: Hypertrophy
mesh term: Ranolazine
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 