<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/NCT01691313</url>
  </required_header>
  <id_info>
    <org_study_id>CRX-VN-002</org_study_id>
    <nct_id>NCT01691313</nct_id>
  </id_info>
  <brief_title>Safety and Efficacy of Vanoxerine for Conversion of Atrial Fibrillation or Flutter to Normal Sinus Rhythm</brief_title>
  <acronym>COR-ART</acronym>
  <official_title>Randomized, Double-blind, Placebo-controlled Dose Modification Study to Evaluate the Safety and Efficacy of Single Doses of Vanoxerine for Conversion of Subjects With Recent Onset Atrial Fibrillation or Flutter to Normal Sinus Rhythm</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Laguna Pharmaceuticals, Inc.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Laguna Pharmaceuticals, Inc.</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Evaluate the safety and efficacy of a single oral dose of vanoxerine compared to placebo, in&#xD;
      a dose modification manner, on the conversion of symptomatic atrial fibrillation (a-fib) or&#xD;
      flutter of recent onset to normal sinus rhythm.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Vanoxerine has important antiarrhythmic properties and may prove effective in converting&#xD;
      AF/AFL to sinus rhythm in subjects with a history of AF. This is a prospective, randomized,&#xD;
      double-blinded, placebo-controlled, dose-modifying study in subjects who have been in&#xD;
      symptomatic AF or AFL for more than 3 hours and less than 7 days as dated by symptoms, who&#xD;
      have AF/AFL documented on ECG at the time of study drug administration, and who satisfy the&#xD;
      inclusion and exclusion criteria. The primary objectives of the trial are to evaluate the&#xD;
      safety and efficacy of a single oral dose of vanoxerine compared to placebo following oral&#xD;
      administration.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>November 2012</start_date>
  <completion_date type="Actual">October 2013</completion_date>
  <primary_completion_date type="Actual">September 2013</primary_completion_date>
  <phase>Phase 2</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>Conversion to Sinus Rhythm</measure>
    <time_frame>baseline through 4 hours</time_frame>
    <description>proportion of subjects who convert to sinus rhythm through 4 hours after start of study drug</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Conversion to Sinus Rhythm</measure>
    <time_frame>baseline through 24 hours</time_frame>
    <description>proportion of subjects who convert to sinus rhythm through 24 hours after start of study drug</description>
  </primary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Actual">104</enrollment>
  <condition>Symptomatic Atrial Fibrillation</condition>
  <condition>Atrial Flutter</condition>
  <arm_group>
    <arm_group_label>vanoxerine 200mg</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>vanoxerine HCl 200mg single dose (2x 100 mg oral capsule)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>placebo to match vanoxerine oral capsule</description>
  </arm_group>
  <arm_group>
    <arm_group_label>vanoxerine 300mg</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>vanoxerine HCl 300 mg single dose (3x 100mg oral capsules)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>vanoxerine 400mg</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>vanoxerine HCl 400 mg single dose (4x 100 mg oral capsules)</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Vanoxerine</intervention_name>
    <description>single oral dose</description>
    <arm_group_label>vanoxerine 200mg</arm_group_label>
    <arm_group_label>vanoxerine 300mg</arm_group_label>
    <arm_group_label>vanoxerine 400mg</arm_group_label>
    <other_name>GBR12909</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>single oral dose</description>
    <arm_group_label>placebo</arm_group_label>
    <other_name>Placebo to match vanoxerine</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  provide written informed consent,&#xD;
&#xD;
          -  male or female 18 years of age or greater; women of child bearing potential must use&#xD;
             adequate contraception&#xD;
&#xD;
          -  symptomatic AF/AFL for more than 3 hours and less than 7 days (168 hours), as dated by&#xD;
             symptoms&#xD;
&#xD;
          -  AF/AFL documented by ECG at the start of study drug administration&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Systolic blood pressure &lt;100 mmHg.&#xD;
&#xD;
          -  Average heart rate &lt;50 bpm.&#xD;
&#xD;
          -  Average QTcF (Fridericia correction) &gt;440 ms.&#xD;
&#xD;
          -  Average QRS interval &gt;140 ms.&#xD;
&#xD;
          -  Paced atrial or ventricular rhythm on ECG.&#xD;
&#xD;
          -  Serum potassium &lt;3.5 meq/L (may be corrected prior to randomization).&#xD;
&#xD;
          -  Received another intravenous Class I or Class III antiarrhythmic drug within prior 3&#xD;
             days.&#xD;
&#xD;
          -  received amiodarone (oral or IV) in prior 3 months.&#xD;
&#xD;
          -  Clinical evidence or history of acute coronary syndrome within 30 days prior to&#xD;
             randomization.&#xD;
&#xD;
          -  Aortic stenosis with aortic valve area equal to or less than 1.0 cm2.&#xD;
&#xD;
          -  Rheumatic mitral stenosis with valve area of &lt;1.5 cm2.&#xD;
&#xD;
          -  Untreated hyperthyroidism.&#xD;
&#xD;
          -  Acute pericarditis.&#xD;
&#xD;
          -  AF/AFL as a result of surgery within the last 7 days&#xD;
&#xD;
          -  History of failed electrical cardioversion&#xD;
&#xD;
          -  History of polymorphic ventricular tachycardia (PVT, e.g. torsades de pointes).&#xD;
&#xD;
          -  History or family history of long QT syndrome.&#xD;
&#xD;
          -  History of ventricular tachycardia requiring drug or device therapy.&#xD;
&#xD;
          -  History of NYHA Heart Failure Class 3 or 4 or recent (within 1 month) onset of heart&#xD;
             failure not related to rapid ventricular response AF.&#xD;
&#xD;
          -  Ejection fraction (EF) of 35% or less.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Howard C Dittrich, MD</last_name>
    <role>Study Director</role>
    <affiliation>ChanRx Corp.</affiliation>
  </overall_official>
  <location>
    <facility>
      <address>
        <city>Ashkelon</city>
        <country>Israel</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Haifa</city>
        <country>Israel</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Nazareth</city>
        <country>Israel</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Safed</city>
        <country>Israel</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Moscow</city>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>St Petersburg</city>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Israel</country>
    <country>Russian Federation</country>
  </location_countries>
  <results_reference>
    <citation>Dittrich HC, Feld GK, Bahnson TD, Camm AJ, Golitsyn S, Katz A, Koontz JI, Kowey PR, Waldo AL, Brown AM. COR-ART: A multicenter, randomized, double-blind, placebo-controlled dose-ranging study to evaluate single oral doses of vanoxerine for conversion of recent-onset atrial fibrillation or flutter to normal sinus rhythm. Heart Rhythm. 2015 Jun;12(6):1105-12. doi: 10.1016/j.hrthm.2015.02.014. Epub 2015 Feb 12.</citation>
    <PMID>25684233</PMID>
  </results_reference>
  <verification_date>November 2015</verification_date>
  <study_first_submitted>September 20, 2012</study_first_submitted>
  <study_first_submitted_qc>September 20, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 24, 2012</study_first_posted>
  <results_first_submitted>October 15, 2015</results_first_submitted>
  <results_first_submitted_qc>November 18, 2015</results_first_submitted_qc>
  <results_first_posted type="Estimate">December 22, 2015</results_first_posted>
  <last_update_submitted>November 18, 2015</last_update_submitted>
  <last_update_submitted_qc>November 18, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">December 22, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>vanoxerine</keyword>
  <keyword>atrial fibrillation</keyword>
  <keyword>atrial flutter</keyword>
  <keyword>a-fib</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Atrial Fibrillation</mesh_term>
    <mesh_term>Atrial Flutter</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Vanoxerine</mesh_term>
  </intervention_browse>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Vanoxerine 200mg</title>
          <description>vanoxerine 200 mg (2x 100mg oral capsules)&#xD;
Vanoxerine: single oral dose</description>
        </group>
        <group group_id="P2">
          <title>Placebo</title>
          <description>placebo to match vanoxerine oral capsule&#xD;
Placebo: single oral dose</description>
        </group>
        <group group_id="P3">
          <title>Vanoxerine 300mg</title>
          <description>vanoxerine 300 mg (3x 100 mg oral capsules) single oral dose</description>
        </group>
        <group group_id="P4">
          <title>Vanoxerine 400mg</title>
          <description>vanoxerine 400 mg (4x100mg oral capsules) single oral dose</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="22"/>
                <participants group_id="P2" count="32"/>
                <participants group_id="P3" count="25"/>
                <participants group_id="P4" count="25"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="22"/>
                <participants group_id="P2" count="32"/>
                <participants group_id="P3" count="25"/>
                <participants group_id="P4" count="25"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Placebo</title>
          <description>placebo to match vanoxerine oral capsule&#xD;
Placebo: single oral dose</description>
        </group>
        <group group_id="B2">
          <title>Vanoxerine 200mg</title>
          <description>vanoxerine oral capsule, 200mg&#xD;
Vanoxerine: single oral dose</description>
        </group>
        <group group_id="B3">
          <title>Vanoxerine 300mg</title>
          <description>vanoxerine oral capsule, 300mg&#xD;
Vanoxerine: single oral dose</description>
        </group>
        <group group_id="B4">
          <title>Vanoxerine 400mg</title>
          <description>vanoxerine oral capsule, 400mg&#xD;
Vanoxerine: single oral dose</description>
        </group>
        <group group_id="B5">
          <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="32"/>
            <count group_id="B2" value="22"/>
            <count group_id="B3" value="25"/>
            <count group_id="B4" value="25"/>
            <count group_id="B5" value="104"/>
          </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="62.3" spread="12.2"/>
                    <measurement group_id="B2" value="61.7" spread="12.2"/>
                    <measurement group_id="B3" value="63.4" spread="9.4"/>
                    <measurement group_id="B4" value="68.4" spread="9.6"/>
                    <measurement group_id="B5" value="64" spread="11"/>
                  </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="10"/>
                    <measurement group_id="B2" value="9"/>
                    <measurement group_id="B3" value="9"/>
                    <measurement group_id="B4" value="13"/>
                    <measurement group_id="B5" value="41"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="22"/>
                    <measurement group_id="B2" value="13"/>
                    <measurement group_id="B3" value="16"/>
                    <measurement group_id="B4" value="12"/>
                    <measurement group_id="B5" value="63"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Conversion to Sinus Rhythm</title>
        <description>proportion of subjects who convert to sinus rhythm through 4 hours after start of study drug</description>
        <time_frame>baseline through 4 hours</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>placebo to match vanoxerine oral capsule&#xD;
Placebo: single oral dose</description>
          </group>
          <group group_id="O2">
            <title>Vanoxerine 200mg</title>
            <description>vanoxerine oral capsule, 200mg&#xD;
Vanoxerine: single oral dose</description>
          </group>
          <group group_id="O3">
            <title>Vanoxerine 300mg</title>
            <description>vanoxerine oral capsule, 300mg&#xD;
Vanoxerine: single oral dose</description>
          </group>
          <group group_id="O4">
            <title>Vanoxerine 400mg</title>
            <description>vanoxerine oral capsule, 400mg&#xD;
Vanoxerine: single oral dose</description>
          </group>
        </group_list>
        <measure>
          <title>Conversion to Sinus Rhythm</title>
          <description>proportion of subjects who convert to sinus rhythm through 4 hours after start of study drug</description>
          <units>participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="32"/>
                <count group_id="O2" value="22"/>
                <count group_id="O3" value="25"/>
                <count group_id="O4" value="25"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4"/>
                    <measurement group_id="O2" value="4"/>
                    <measurement group_id="O3" value="11"/>
                    <measurement group_id="O4" value="13"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Conversion to Sinus Rhythm</title>
        <description>proportion of subjects who convert to sinus rhythm through 24 hours after start of study drug</description>
        <time_frame>baseline through 24 hours</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>placebo to match vanoxerine oral capsule&#xD;
Placebo: single oral dose</description>
          </group>
          <group group_id="O2">
            <title>Vanoxerine 200mg</title>
            <description>vanoxerine oral capsule, 200mg&#xD;
Vanoxerine: single oral dose</description>
          </group>
          <group group_id="O3">
            <title>Vanoxerine 300mg</title>
            <description>vanoxerine oral capsule, 300mg&#xD;
Vanoxerine: single oral dose</description>
          </group>
          <group group_id="O4">
            <title>Vanoxerine 400mg</title>
            <description>vanoxerine oral capsule, 400mg&#xD;
Vanoxerine: single oral dose</description>
          </group>
        </group_list>
        <measure>
          <title>Conversion to Sinus Rhythm</title>
          <description>proportion of subjects who convert to sinus rhythm through 24 hours after start of study drug</description>
          <units>participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="32"/>
                <count group_id="O2" value="22"/>
                <count group_id="O3" value="25"/>
                <count group_id="O4" value="25"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="10"/>
                    <measurement group_id="O2" value="13"/>
                    <measurement group_id="O3" value="16"/>
                    <measurement group_id="O4" value="21"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <group_list>
        <group group_id="E1">
          <title>Placebo</title>
          <description>placebo to match vanoxerine oral capsule&#xD;
Placebo: single oral dose</description>
        </group>
        <group group_id="E2">
          <title>Vanoxerine 200mg</title>
          <description>vanoxerine oral capsule, 200mg&#xD;
Vanoxerine: single oral dose</description>
        </group>
        <group group_id="E3">
          <title>Vanoxerine 300mg</title>
          <description>vanoxerine oral capsule, 300mg&#xD;
Vanoxerine: single oral dose</description>
        </group>
        <group group_id="E4">
          <title>Vanoxerine 400mg</title>
          <description>vanoxerine oral capsule, 400mg&#xD;
Vanoxerine: single oral dose</description>
        </group>
      </group_list>
      <serious_events>
        <default_assessment>Systematic Assessment</default_assessment>
        <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="32"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="22"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="25"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="25"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Peripheral edema</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="25"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="25"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Upper respiratory tract infection</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="22"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="25"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>4</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="32"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="22"/>
                <counts group_id="E3" subjects_affected="8" subjects_at_risk="25"/>
                <counts group_id="E4" subjects_affected="17" subjects_at_risk="25"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Sinus bradycardia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="25"/>
                <counts group_id="E4" events="2" subjects_affected="2" subjects_at_risk="25"/>
              </event>
              <event>
                <sub_title>Supraventricular extrasystoles</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="25"/>
                <counts group_id="E4" events="2" subjects_affected="2" subjects_at_risk="25"/>
              </event>
              <event>
                <sub_title>Ventricular extrasystoles</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="32"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="25"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="25"/>
              </event>
              <event>
                <sub_title>Bradyarrhythmia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="25"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="25"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Dyspepsia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="25"/>
                <counts group_id="E4" events="2" subjects_affected="2" subjects_at_risk="25"/>
              </event>
              <event>
                <sub_title>Nausea</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="22"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="25"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="25"/>
              </event>
              <event>
                <sub_title>Vomiting</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="22"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="25"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Pyrexia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="32"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="25"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="25"/>
              </event>
              <event>
                <sub_title>Asthenia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="22"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="25"/>
              </event>
              <event>
                <sub_title>Chest discomfort</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="25"/>
              </event>
              <event>
                <sub_title>Oedema Peripheral</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="25"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Upper respiratory tract infection</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="22"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="25"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="25"/>
              </event>
              <event>
                <sub_title>Bronchitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="25"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="25"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>ECG QT prolonged</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E4" events="3" subjects_affected="3" subjects_at_risk="25"/>
              </event>
              <event>
                <sub_title>Alanine aminotransferase increased</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="22"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="25"/>
              </event>
              <event>
                <sub_title>International normalized ratio increased</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="22"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="25"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Muscular weakness</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="25"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Dizziness</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E4" events="3" subjects_affected="3" subjects_at_risk="25"/>
              </event>
              <event>
                <sub_title>Headache</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E4" events="2" subjects_affected="2" subjects_at_risk="25"/>
              </event>
              <event>
                <sub_title>Paraesthesia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="25"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="25"/>
              </event>
              <event>
                <sub_title>Syncope</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="25"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="25"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Dyspnoea</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="25"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Hyperhidrosis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="25"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Hypotension</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="32"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="25"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="25"/>
              </event>
              <event>
                <sub_title>Hypertension</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="25"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Howard C. Dittrich</name_or_title>
      <organization>Laguna Pharmaceuticals, Inc.</organization>
      <phone>858-405-1429</phone>
      <email>HDittrich@lagunarx.com</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/NCT01691313
org study id: CRX-VN-002
nct id: NCT01691313
lead sponsor: 
has dmc: Yes
Evaluate the safety and efficacy of a single oral dose of vanoxerine compared to placebo, in
      a dose modification manner, on the conversion of symptomatic atrial fibrillation (a-fib) or
      flutter of recent onset to normal sinus rhythm.
Vanoxerine has important antiarrhythmic properties and may prove effective in converting
      AF/AFL to sinus rhythm in subjects with a history of AF. This is a prospective, randomized,
      double-blinded, placebo-controlled, dose-modifying study in subjects who have been in
      symptomatic AF or AFL for more than 3 hours and less than 7 days as dated by symptoms, who
      have AF/AFL documented on ECG at the time of study drug administration, and who satisfy the
      inclusion and exclusion criteria. The primary objectives of the trial are to evaluate the
      safety and efficacy of a single oral dose of vanoxerine compared to placebo following oral
      administration.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Conversion to Sinus Rhythm
time frame: baseline through 4 hours
description: proportion of subjects who convert to sinus rhythm through 4 hours after start of study drug
measure: Conversion to Sinus Rhythm
time frame: baseline through 24 hours
description: proportion of subjects who convert to sinus rhythm through 24 hours after start of study drug
arm group label: vanoxerine 200mg
arm group type: Experimental
description: vanoxerine HCl 200mg single dose (2x 100 mg oral capsule)
arm group label: placebo
arm group type: Placebo Comparator
description: placebo to match vanoxerine oral capsule
arm group label: vanoxerine 300mg
arm group type: Experimental
description: vanoxerine HCl 300 mg single dose (3x 100mg oral capsules)
arm group label: vanoxerine 400mg
arm group type: Experimental
description: vanoxerine HCl 400 mg single dose (4x 100 mg oral capsules)
intervention type: Drug
intervention name: Vanoxerine
description: single oral dose
arm group label: vanoxerine 200mg
arm group label: vanoxerine 300mg
arm group label: vanoxerine 400mg
other name: GBR12909
intervention type: Drug
intervention name: Placebo
description: single oral dose
arm group label: placebo
other name: Placebo to match vanoxerine
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Howard C Dittrich, MD
role: Study Director
affiliation: ChanRx Corp.
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: Israel
country: Russian Federation
citation: Dittrich HC, Feld GK, Bahnson TD, Camm AJ, Golitsyn S, Katz A, Koontz JI, Kowey PR, Waldo AL, Brown AM. COR-ART: A multicenter, randomized, double-blind, placebo-controlled dose-ranging study to evaluate single oral doses of vanoxerine for conversion of recent-onset atrial fibrillation or flutter to normal sinus rhythm. Heart Rhythm. 2015 Jun;12(6):1105-12. doi: 10.1016/j.hrthm.2015.02.014. Epub 2015 Feb 12.
PMID: 25684233
responsible party type: Sponsor
mesh term: Atrial Fibrillation
mesh term: Atrial Flutter
mesh term: Vanoxerine
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 