<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/NCT02189252</url>
  </required_header>
  <id_info>
    <org_study_id>D5880C00003</org_study_id>
    <secondary_id>OM-EPA-013</secondary_id>
    <nct_id>NCT02189252</nct_id>
  </id_info>
  <brief_title>An Open-Label Crossover Study to Compare the Relative Bioavailability, Efficacy and Safety of Epanova® and Lovaza® in Men and Women With a History of Pancreatitis</brief_title>
  <acronym>ECLIPSEIV</acronym>
  <official_title>A Randomized, Open-Label Crossover Study to Compare the Relative Bioavailability, Efficacy, and Safety of Epanova® and Lovaza® in Men and Women With a History of Pancreatitis</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>AstraZeneca</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>AstraZeneca</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is a randomized, open-label crossover study. The primary objective of this study is to&#xD;
      compare the relative bioavailability of eicosapentaenoic acid (EPA), docosahexaenoic acid&#xD;
      (DHA), docosapentaenoic acid (DPA), and the ethyl esters of EPA and DHA in plasma from a&#xD;
      single 2 g or 4 g dose of Epanova® or 4 g Lovaza®.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>October 2014</start_date>
  <completion_date type="Actual">July 2015</completion_date>
  <primary_completion_date type="Actual">July 2015</primary_completion_date>
  <phase>Phase 1</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Crossover Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Baseline-adjusted AUC0-24 for Plasma Total EPA + Total DHA</measure>
    <time_frame>participants were followed for the duration of study, up to 12 weeks, each treatment having a 4-week duration and a 4-week wash off period in between.</time_frame>
    <description>AUC0-24: Area under the plasma concentration versus time curve, from time 0 to 24 hours after start of the meal</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Baseline-adjusted Cmax for Plasma Total EPA + Total DHA</measure>
    <time_frame>participants were followed for the duration of study, up to 12 weeks, each treatment having a 4-week duration and a 4-week wash off period in between.</time_frame>
    <description>Cmax: Maximum measured plasma concentration over the time span specified</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Baseline-adjusted AUC0-24 for Plasma Total EPA</measure>
    <time_frame>participants were followed for the duration of study, up to 12 weeks, each treatment having a 4-week duration and a 4-week wash off period in between.</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Baseline-adjusted Cmax for Plasma Total EPA</measure>
    <time_frame>participants were followed for the duration of study, up to 12 weeks, each treatment having a 4-week duration and a 4-week wash off period in between.</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Baseline-adjusted AUC0-24 for Plasma Total DHA</measure>
    <time_frame>participants were followed for the duration of study, up to 12 weeks, each treatment having a 4-week duration and a 4-week wash off period in between.</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Baseline-adjusted Cmax for Plasma Total DHA</measure>
    <time_frame>This is a crossover study with two treatment periods. The estimated treatment effects were based on the within-subject comparison between the two treatments, each having a 4-week duration and a 4-week wash off period in between.</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Baseline-adjusted AUC0-24 for Plasma Total DPA</measure>
    <time_frame>participants were followed for the duration of study, up to 12 weeks, each treatment having a 4-week duration and a 4-week wash off period in between.</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Baseline-adjusted Cmax for Plasma Total DPA</measure>
    <time_frame>participants were followed for the duration of study, up to 12 weeks, each treatment having a 4-week duration and a 4-week wash off period in between.</time_frame>
  </secondary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Actual">30</enrollment>
  <condition>Severe Hypertriglyceridemia</condition>
  <arm_group>
    <arm_group_label>E4:L4</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Crossover Sequence</description>
  </arm_group>
  <arm_group>
    <arm_group_label>L4:E4</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Crossover Sequence</description>
  </arm_group>
  <arm_group>
    <arm_group_label>E2:L4</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Crossover Sequence</description>
  </arm_group>
  <arm_group>
    <arm_group_label>L4:E2</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Crossover Sequence</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Epanova</intervention_name>
    <arm_group_label>E2:L4</arm_group_label>
    <arm_group_label>E4:L4</arm_group_label>
    <arm_group_label>L4:E2</arm_group_label>
    <arm_group_label>L4:E4</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Lovaza</intervention_name>
    <arm_group_label>E2:L4</arm_group_label>
    <arm_group_label>E4:L4</arm_group_label>
    <arm_group_label>L4:E2</arm_group_label>
    <arm_group_label>L4:E4</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Male or female, ≥18 years of age;&#xD;
&#xD;
          2. History of serum TG concentration ≥500 mg/dL within the past 5 years;&#xD;
&#xD;
          3. Have at least one episode of documented hospitalization for pancreatitis due to&#xD;
             hypertriglyceridemia in his/her lifetime;&#xD;
&#xD;
          4. Have no health conditions that would prevent him/her from fulfilling the study&#xD;
             requirements as judged by the Investigator on the basis of physical examination, ECG,&#xD;
             medical history, and routine laboratory test results;&#xD;
&#xD;
          5. Willing to maintain his/her current activity level and to follow either the NCEP TLC&#xD;
             diet with a caloric target for weight maintenance or a prescribed low-fat diet during&#xD;
             the screening, treatment, and washout periods (Visits 1 through 6b; Weeks -4 through&#xD;
             12);&#xD;
&#xD;
          6. Willing to eat the standardized breakfast, lunch, and dinner meals and snacks before&#xD;
             and during Visits 4b and 6b (Weeks 4 and 12);&#xD;
&#xD;
          7. Willing to abstain from alcohol consumption and avoid vigorous physical activity for&#xD;
             48 hours prior to Visits 3 through 6b (Weeks 0 through 12); and&#xD;
&#xD;
          8. Subject understands the study procedures and is willing and able to sign the informed&#xD;
             consent form to participate in the study and the Health Insurance Portability and&#xD;
             Accountability Act authorization for release of relevant protected health information&#xD;
             to the Investigators and study personnel.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. An allergy or intolerance to omega-3 fatty acids, omega-3-acid ethyl esters, fish, or&#xD;
             any of the components of the standardized breakfast, lunch, or dinner meals or snacks&#xD;
             (as described to them by study staff)&#xD;
&#xD;
          2. Poorly controlled hypertension (resting blood pressure ≥160 mmHg systolic and/or ≥100&#xD;
             mmHg diastolic) prior to randomization (Visit 3 [Week 0])&#xD;
&#xD;
          3. A history of cancer (other than basal cell carcinoma) in the last 2 years&#xD;
&#xD;
          4. A recent cardiovascular event (i.e., myocardial infarction, acute coronary syndrome,&#xD;
             new onset angina, stroke, transient ischemic attack, unstable congestive heart failure&#xD;
             requiring a change in treatment), aortic aneurysm or resection, carotid&#xD;
             endarterectomy, or revascularization procedure within the 6 months prior to Visit 1&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>130 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Andrea L Lawless, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Biofortis, Inc Addison IL 60101</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Kansas City</city>
        <state>Kansas</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Cincinnati</city>
        <state>Ohio</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Philadelphia</city>
        <state>Pennsylvania</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Chocoutimi</city>
        <state>Quebec</state>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
    <country>United States</country>
  </location_countries>
  <verification_date>May 2016</verification_date>
  <study_first_submitted>June 23, 2014</study_first_submitted>
  <study_first_submitted_qc>July 11, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 14, 2014</study_first_posted>
  <results_first_submitted>March 29, 2016</results_first_submitted>
  <results_first_submitted_qc>May 11, 2016</results_first_submitted_qc>
  <results_first_posted type="Estimate">June 20, 2016</results_first_posted>
  <last_update_submitted>May 11, 2016</last_update_submitted>
  <last_update_submitted_qc>May 11, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">June 20, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Pancreatitis</mesh_term>
    <mesh_term>Hypertriglyceridemia</mesh_term>
  </condition_browse>

  <clinical_results>

    <participant_flow>
      <recruitment_details>The study subjects were recruited at 6 sites. In total, 30 subjects were screened, of which 15 were randomized to 1 of 4 treatment sequences.</recruitment_details>
      <pre_assignment_details>No applicable</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>Treatment Sequence 1</title>
          <description>Epanova 4g per day: Lovaza 4g per day</description>
        </group>
        <group group_id="P2">
          <title>Treatment Sequence 2</title>
          <description>Lovaza 4 g per day:Epanova 4 g per day : 4 subjects</description>
        </group>
        <group group_id="P3">
          <title>Treatment Sequence 3</title>
          <description>Epanova 2g per day:Lovaza 4g per day:</description>
        </group>
        <group group_id="P4">
          <title>Treatment Sequence 4</title>
          <description>Lovaza 4g per day:Epanova 2g per day:</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Period 1 (Visit 4b, Week 4)</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="4"/>
                <participants group_id="P2" count="4"/>
                <participants group_id="P3" count="3"/>
                <participants group_id="P4" count="4"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="4"/>
                <participants group_id="P2" count="2"/>
                <participants group_id="P3" count="3"/>
                <participants group_id="P4" count="4"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="2"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="1"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Adverse Event</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="1"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
        <period>
          <title>Period 2 (Visit6b, Week 12)</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="4"/>
                <participants group_id="P2" count="2"/>
                <participants group_id="P3" count="3"/>
                <participants group_id="P4" count="4"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="4"/>
                <participants group_id="P2" count="2"/>
                <participants group_id="P3" count="3"/>
                <participants group_id="P4" count="4"/>
              </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>Treatment Sequence 1</title>
          <description>Epanova 4 g per day:Lovaza 4 g per day</description>
        </group>
        <group group_id="B2">
          <title>Treatment Sequence 2</title>
          <description>Lovaza 4 g per day:Epanova 4 g per day : 4 subjects</description>
        </group>
        <group group_id="B3">
          <title>Treatment Sequence 3</title>
          <description>Epanova 2 g per day:Lovaza 4 g per day</description>
        </group>
        <group group_id="B4">
          <title>Treatment Sequence 4</title>
          <description>Lovaza 4 g per day:Epanova 2 g per day: 4 subjects</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="4"/>
            <count group_id="B2" value="4"/>
            <count group_id="B3" value="3"/>
            <count group_id="B4" value="4"/>
            <count group_id="B5" value="15"/>
          </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="47.5" spread="6.86"/>
                    <measurement group_id="B2" value="46.0" spread="13.09"/>
                    <measurement group_id="B3" value="53.0" spread="16.46"/>
                    <measurement group_id="B4" value="53.5" spread="11.27"/>
                    <measurement group_id="B5" value="49.8" spread="11.16"/>
                  </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="1"/>
                    <measurement group_id="B2" value="3"/>
                    <measurement group_id="B3" value="1"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="5"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="2"/>
                    <measurement group_id="B4" value="4"/>
                    <measurement group_id="B5" value="10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Baseline-adjusted AUC0-24 for Plasma Total EPA + Total DHA</title>
        <description>AUC0-24: Area under the plasma concentration versus time curve, from time 0 to 24 hours after start of the meal</description>
        <time_frame>participants were followed for the duration of study, up to 12 weeks, each treatment having a 4-week duration and a 4-week wash off period in between.</time_frame>
        <population>PK population</population>
        <group_list>
          <group group_id="O1">
            <title>Epanova 2 g</title>
            <description>Once daily (QD)</description>
          </group>
          <group group_id="O2">
            <title>Epanova 4 g</title>
            <description>Once daily (QD)</description>
          </group>
          <group group_id="O3">
            <title>Lovaza 4 g</title>
            <description>Once daily (QD)</description>
          </group>
        </group_list>
        <measure>
          <title>Baseline-adjusted AUC0-24 for Plasma Total EPA + Total DHA</title>
          <description>AUC0-24: Area under the plasma concentration versus time curve, from time 0 to 24 hours after start of the meal</description>
          <population>PK population</population>
          <units>hr*nmol/mL</units>
          <param>Geometric Mean</param>
          <dispersion>Geometric Coefficient of Variation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="6"/>
                <count group_id="O2" value="6"/>
                <count group_id="O3" value="12"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="17000" spread="121.7"/>
                    <measurement group_id="O2" value="18000" spread="104.6"/>
                    <measurement group_id="O3" value="12500" spread="80.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>In order to address the issue of multiple testing while maintaining overall type I error, a closed testing sequence was used involving 4 analyses stated in the primary objective of this study. In total, 4 statistical tests, each at a significance level of 5%, were carried along the fixed sequence until the first statistically non-significant treatment difference was observed (i.e. p-value&gt;0.05). This is the first test in the fixed testing sequence.</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.2702</p_value>
            <p_value_desc>The closed sequential testing procedure stopped at this step as the P Value is greater than 0.05.</p_value_desc>
            <method>Mixed Models Analysis</method>
            <param_type>Geometric mean ratio in %</param_type>
            <param_value>160.05</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>64.71</ci_lower_limit>
            <ci_upper_limit>395.82</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>In order to address the issue of multiple testing while maintaining overall type I error, a closed testing sequence was used involving 4 analyses stated in the primary objective of this study. In total, 4 statistical tests, each at a significance level of 5%, were carried along the fixed sequence until the first statistically non-significant treatment difference was observed (i.e. p-value&gt;0.05). This is the second test in the fixed testing sequence.</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.6367</p_value>
            <p_value_desc>The p-value was only interpreted descriptively</p_value_desc>
            <method>Mixed Models Analysis</method>
            <param_type>Geometric mean ratio in %</param_type>
            <param_value>121.61</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>49.17</ci_lower_limit>
            <ci_upper_limit>300.76</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Baseline-adjusted Cmax for Plasma Total EPA + Total DHA</title>
        <description>Cmax: Maximum measured plasma concentration over the time span specified</description>
        <time_frame>participants were followed for the duration of study, up to 12 weeks, each treatment having a 4-week duration and a 4-week wash off period in between.</time_frame>
        <population>PK population</population>
        <group_list>
          <group group_id="O1">
            <title>Epanova 2 g</title>
            <description>Once daily (QD)</description>
          </group>
          <group group_id="O2">
            <title>Epanova 4 g</title>
            <description>Once daily (QD)</description>
          </group>
          <group group_id="O3">
            <title>Lovaza 4 g</title>
            <description>Once daily (QD)</description>
          </group>
        </group_list>
        <measure>
          <title>Baseline-adjusted Cmax for Plasma Total EPA + Total DHA</title>
          <description>Cmax: Maximum measured plasma concentration over the time span specified</description>
          <population>PK population</population>
          <units>nmol/mL</units>
          <param>Geometric Mean</param>
          <dispersion>Geometric Coefficient of Variation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="6"/>
                <count group_id="O2" value="6"/>
                <count group_id="O3" value="12"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1090" spread="78.6"/>
                    <measurement group_id="O2" value="1200" spread="70.2"/>
                    <measurement group_id="O3" value="712" spread="76.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>In order to address the issue of multiple testing while maintaining overall type I error, a closed testing sequence was used involving 4 analyses stated in the primary objective of this study. In total, 4 statistical tests, each at a significance level of 5%, were carried along the fixed sequence until the first statistically non-significant treatment difference was observed (i.e. p-value&gt;0.05). This is the third test in the fixed testing sequence.</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.0511</p_value>
            <p_value_desc>The p-value was only interpreted descriptively</p_value_desc>
            <method>Mixed Models Analysis</method>
            <param_type>Geometric mean ratio in %</param_type>
            <param_value>193.91</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>99.61</ci_lower_limit>
            <ci_upper_limit>377.47</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>In order to address the issue of multiple testing while maintaining overall type I error, a closed testing sequence was used involving 4 analyses stated in the primary objective of this study. In total, 4 statistical tests, each at a significance level of 5%, were carried along the fixed sequence until the first statistically non-significant treatment difference was observed (i.e. p-value&gt;0.05). This is the fourth test in the fixed testing sequence.</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.3543</p_value>
            <p_value_desc>The p-value was only interpreted descriptively</p_value_desc>
            <method>Mixed Models Analysis</method>
            <param_type>Geometric mean ratio in %</param_type>
            <param_value>133.32</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>68.49</ci_lower_limit>
            <ci_upper_limit>259.52</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Baseline-adjusted AUC0-24 for Plasma Total EPA</title>
        <time_frame>participants were followed for the duration of study, up to 12 weeks, each treatment having a 4-week duration and a 4-week wash off period in between.</time_frame>
        <population>PK Population</population>
        <group_list>
          <group group_id="O1">
            <title>Epanova 2 g</title>
            <description>Once daily (QD)</description>
          </group>
          <group group_id="O2">
            <title>Epanova 4 g</title>
            <description>Once daily (QD)</description>
          </group>
          <group group_id="O3">
            <title>Lovaza 4 g</title>
            <description>Once daily (QD)</description>
          </group>
        </group_list>
        <measure>
          <title>Baseline-adjusted AUC0-24 for Plasma Total EPA</title>
          <population>PK Population</population>
          <units>hr*ug/mL</units>
          <param>Geometric Mean</param>
          <dispersion>Geometric Coefficient of Variation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="6"/>
                <count group_id="O2" value="6"/>
                <count group_id="O3" value="12"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3510" spread="117.8"/>
                    <measurement group_id="O2" value="3930" spread="83.0"/>
                    <measurement group_id="O3" value="1730" spread="78.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.0210</p_value>
            <method>Mixed Models Analysis</method>
            <param_type>Geometric mean ratio in %</param_type>
            <param_value>259.19</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>119.75</ci_lower_limit>
            <ci_upper_limit>560.99</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.1256</p_value>
            <method>Mixed Models Analysis</method>
            <param_type>Geometric mean ratio in %</param_type>
            <param_value>177.95</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>82.22</ci_lower_limit>
            <ci_upper_limit>385.16</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Baseline-adjusted Cmax for Plasma Total EPA</title>
        <time_frame>participants were followed for the duration of study, up to 12 weeks, each treatment having a 4-week duration and a 4-week wash off period in between.</time_frame>
        <population>PK Population</population>
        <group_list>
          <group group_id="O1">
            <title>Epanova 2 g</title>
            <description>Once daily (QD)</description>
          </group>
          <group group_id="O2">
            <title>Epanova 4 g</title>
            <description>Once daily (QD)</description>
          </group>
          <group group_id="O3">
            <title>Lovaza 4 g</title>
            <description>Once daily (QD)</description>
          </group>
        </group_list>
        <measure>
          <title>Baseline-adjusted Cmax for Plasma Total EPA</title>
          <population>PK Population</population>
          <units>ug/mL</units>
          <param>Geometric Mean</param>
          <dispersion>Geometric Coefficient of Variation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="6"/>
                <count group_id="O2" value="6"/>
                <count group_id="O3" value="12"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="221" spread="83.0"/>
                    <measurement group_id="O2" value="255" spread="65.7"/>
                    <measurement group_id="O3" value="100" spread="74.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.0025</p_value>
            <p_value_desc>The p-value was only interpreted descriptively</p_value_desc>
            <method>Mixed Models Analysis</method>
            <param_type>Geometric mean ratio in %</param_type>
            <param_value>298.91</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>164.32</ci_lower_limit>
            <ci_upper_limit>543.74</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.0418</p_value>
            <p_value_desc>The p-value was only interpreted descriptively</p_value_desc>
            <method>Mixed Models Analysis</method>
            <param_type>Geometric mean ratio in %</param_type>
            <param_value>187.28</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>102.95</ci_lower_limit>
            <ci_upper_limit>340.66</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Baseline-adjusted AUC0-24 for Plasma Total DHA</title>
        <time_frame>participants were followed for the duration of study, up to 12 weeks, each treatment having a 4-week duration and a 4-week wash off period in between.</time_frame>
        <population>PK Population</population>
        <group_list>
          <group group_id="O1">
            <title>Epanova 2 g</title>
            <description>Once daily (QD)</description>
          </group>
          <group group_id="O2">
            <title>Epanova 4 g</title>
            <description>Once daily (QD)</description>
          </group>
          <group group_id="O3">
            <title>Lovaza 4 g</title>
            <description>Once daily (QD)</description>
          </group>
        </group_list>
        <measure>
          <title>Baseline-adjusted AUC0-24 for Plasma Total DHA</title>
          <population>PK Population</population>
          <units>hr*ug/mL</units>
          <param>Geometric Mean</param>
          <dispersion>Geometric Coefficient of Variation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="6"/>
                <count group_id="O2" value="6"/>
                <count group_id="O3" value="12"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1710" spread="136.3"/>
                    <measurement group_id="O2" value="1550" spread="195.2"/>
                    <measurement group_id="O3" value="2190" spread="86.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.6833</p_value>
            <method>Mixed Models Analysis</method>
            <param_type>Geometric mean ratio in %</param_type>
            <param_value>79.36</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>22.95</ci_lower_limit>
            <ci_upper_limit>274.45</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.5220</p_value>
            <method>Mixed Models Analysis</method>
            <param_type>Geometric mean ratio in %</param_type>
            <param_value>69.39</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>20.07</ci_lower_limit>
            <ci_upper_limit>239.98</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Baseline-adjusted Cmax for Plasma Total DHA</title>
        <time_frame>This is a crossover study with two treatment periods. The estimated treatment effects were based on the within-subject comparison between the two treatments, each having a 4-week duration and a 4-week wash off period in between.</time_frame>
        <population>PK Population</population>
        <group_list>
          <group group_id="O1">
            <title>Epanova 2 g</title>
            <description>Once daily (QD)</description>
          </group>
          <group group_id="O2">
            <title>Epanova 4 g</title>
            <description>Once daily (QD)</description>
          </group>
          <group group_id="O3">
            <title>Lovaza 4 g</title>
            <description>Once daily (QD)</description>
          </group>
        </group_list>
        <measure>
          <title>Baseline-adjusted Cmax for Plasma Total DHA</title>
          <population>PK Population</population>
          <units>ug/mL</units>
          <param>Geometric Mean</param>
          <dispersion>Geometric Coefficient of Variation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="6"/>
                <count group_id="O2" value="6"/>
                <count group_id="O3" value="12"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="116" spread="76.1"/>
                    <measurement group_id="O2" value="118" spread="89.2"/>
                    <measurement group_id="O3" value="128" spread="82.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.9034</p_value>
            <method>Mixed Models Analysis</method>
            <param_type>Geometric mean ratio in %</param_type>
            <param_value>104.78</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>44.92</ci_lower_limit>
            <ci_upper_limit>244.41</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.5782</p_value>
            <method>Mixed Models Analysis</method>
            <param_type>Geometric mean ratio in %</param_type>
            <param_value>80.58</param_value>
            <ci_percent>95</ci_percent>
            <ci_lower_limit>34.55</ci_lower_limit>
            <ci_upper_limit>187.95</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Baseline-adjusted AUC0-24 for Plasma Total DPA</title>
        <time_frame>participants were followed for the duration of study, up to 12 weeks, each treatment having a 4-week duration and a 4-week wash off period in between.</time_frame>
        <population>PK Population</population>
        <group_list>
          <group group_id="O1">
            <title>Epanova 2 g</title>
            <description>Once daily (QD)</description>
          </group>
          <group group_id="O2">
            <title>Epanova 4 g</title>
            <description>Once daily (QD)</description>
          </group>
          <group group_id="O3">
            <title>Lovaza 4 g</title>
            <description>Once daily (QD)</description>
          </group>
        </group_list>
        <measure>
          <title>Baseline-adjusted AUC0-24 for Plasma Total DPA</title>
          <population>PK Population</population>
          <units>hr*ug/mL</units>
          <param>Geometric Mean</param>
          <dispersion>Geometric Coefficient of Variation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="6"/>
                <count group_id="O2" value="6"/>
                <count group_id="O3" value="12"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="244" spread="225.3"/>
                    <measurement group_id="O2" value="380" spread="240.9"/>
                    <measurement group_id="O3" value="108" spread="374.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.0391</p_value>
            <method>Mixed Models Analysis</method>
            <param_type>Geometric mean ratio in %</param_type>
            <param_value>753.75</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>112.03</ci_lower_limit>
            <ci_upper_limit>5071.6</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.9578</p_value>
            <method>Mixed Models Analysis</method>
            <param_type>Geometric mean ratio in %</param_type>
            <param_value>104.98</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>15.60</ci_lower_limit>
            <ci_upper_limit>706.33</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Baseline-adjusted Cmax for Plasma Total DPA</title>
        <time_frame>participants were followed for the duration of study, up to 12 weeks, each treatment having a 4-week duration and a 4-week wash off period in between.</time_frame>
        <population>PK Population</population>
        <group_list>
          <group group_id="O1">
            <title>Epanova 2 g</title>
            <description>Once daily (QD)</description>
          </group>
          <group group_id="O2">
            <title>Epanova 4 g</title>
            <description>Once daily (QD)</description>
          </group>
          <group group_id="O3">
            <title>Lovaza 4 g</title>
            <description>Once daily (QD)</description>
          </group>
        </group_list>
        <measure>
          <title>Baseline-adjusted Cmax for Plasma Total DPA</title>
          <population>PK Population</population>
          <units>ug/mL</units>
          <param>Geometric Mean</param>
          <dispersion>Geometric Coefficient of Variation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="6"/>
                <count group_id="O2" value="6"/>
                <count group_id="O3" value="12"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="23.0" spread="64.2"/>
                    <measurement group_id="O2" value="26.4" spread="83.3"/>
                    <measurement group_id="O3" value="11.1" spread="128.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.0186</p_value>
            <method>Mixed Models Analysis</method>
            <param_type>Geometric mean ratio in %</param_type>
            <param_value>376.64</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>128.55</ci_lower_limit>
            <ci_upper_limit>1103.5</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.5955</p_value>
            <method>Mixed Models Analysis</method>
            <param_type>Geometric mean ratio in %</param_type>
            <param_value>131.74</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>44.97</ci_lower_limit>
            <ci_upper_limit>386.00</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
    </outcome_list>

    <reported_events>
      <group_list>
        <group group_id="E1">
          <title>Epanova 2 g (I)</title>
          <description>Treatment period I</description>
        </group>
        <group group_id="E2">
          <title>Epanova 4 g (I)</title>
          <description>Treatment period I</description>
        </group>
        <group group_id="E3">
          <title>Lovaza 4 g (I)</title>
          <description>Treatment period I</description>
        </group>
        <group group_id="E4">
          <title>Epanova 2 g (II)</title>
          <description>Treatment period II</description>
        </group>
        <group group_id="E5">
          <title>Epanova 4 g (II)</title>
          <description>Treatment period II</description>
        </group>
        <group group_id="E6">
          <title>Lovaza 4 g (II)</title>
          <description>Treatment period II</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="3"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="7"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <default_vocab>MedDRA 16.1</default_vocab>
        <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="2" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="4"/>
                <counts group_id="E3" subjects_affected="5" subjects_at_risk="8"/>
                <counts group_id="E4" subjects_affected="3" subjects_at_risk="4"/>
                <counts group_id="E5" subjects_affected="2" subjects_at_risk="2"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="7"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Blood and lymphatic system disorders</title>
            <event_list>
              <event>
                <sub_title>Any</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="7"/>
              </event>
              <event>
                <sub_title>Anemia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="7"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Any</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="4"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="8"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="4"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="2"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="7"/>
              </event>
              <event>
                <sub_title>Diarrhea</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="4"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="4"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="2"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="7"/>
              </event>
              <event>
                <sub_title>Nausea</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="4"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="4"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="7"/>
              </event>
              <event>
                <sub_title>Abdominal distension</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="7"/>
              </event>
              <event>
                <sub_title>Abdominal pain</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="2"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="7"/>
              </event>
              <event>
                <sub_title>Dyspepsia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="7"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Any</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="4"/>
                <counts group_id="E3" subjects_affected="3" subjects_at_risk="8"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="4"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="7"/>
              </event>
              <event>
                <sub_title>Local swelling</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="8"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="7"/>
              </event>
              <event>
                <sub_title>Asthenia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="7"/>
              </event>
              <event>
                <sub_title>Pyrexia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="4"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="7"/>
              </event>
              <event>
                <sub_title>Fatigue</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="8"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="4"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="7"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Any</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="4"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="4"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="2"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="7"/>
              </event>
              <event>
                <sub_title>Abdominal abscess</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="4"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="7"/>
              </event>
              <event>
                <sub_title>Bronchitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="4"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="7"/>
              </event>
              <event>
                <sub_title>Influenza</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="4"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="7"/>
              </event>
              <event>
                <sub_title>Nasopharyngitis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="7"/>
              </event>
              <event>
                <sub_title>Pharyngitis streptococcal</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="4"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="7"/>
              </event>
              <event>
                <sub_title>Viral upper respiratory tract infection</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="2"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="7"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Any</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="4"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="8"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="7"/>
              </event>
              <event>
                <sub_title>Back pain</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="4"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="7"/>
              </event>
              <event>
                <sub_title>Myopathy</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="7"/>
              </event>
              <event>
                <sub_title>Pain in extremity</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="7"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Any</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="4"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="7"/>
              </event>
              <event>
                <sub_title>Headache</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="4"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="7"/>
              </event>
              <event>
                <sub_title>Lethargy</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="7"/>
              </event>
              <event>
                <sub_title>Somnolence</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="7"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Renal and urinary disorders</title>
            <event_list>
              <event>
                <sub_title>Any</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="7"/>
              </event>
              <event>
                <sub_title>Renal failure</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="7"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Any</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="7"/>
              </event>
              <event>
                <sub_title>Epistaxis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="7"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Any</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="4"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="7"/>
              </event>
              <event>
                <sub_title>Xanthelasma</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="4"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="7"/>
              </event>
              <event>
                <sub_title>Xanthoma</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="4"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="7"/>
              </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>
      <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>Hong Yang, Study Statistician</name_or_title>
      <organization>AstraZeneca AB</organization>
      <phone>+46-(0)317762397</phone>
      <email>hong.yang1@astrazeneca.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/NCT02189252
org study id: D5880C00003
secondary id: OM-EPA-013
nct id: NCT02189252
lead sponsor: 
has dmc: No
This is a randomized, open-label crossover study. The primary objective of this study is to
      compare the relative bioavailability of eicosapentaenoic acid (EPA), docosahexaenoic acid
      (DHA), docosapentaenoic acid (DPA), and the ethyl esters of EPA and DHA in plasma from a
      single 2 g or 4 g dose of Epanova® or 4 g Lovaza®.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Baseline-adjusted AUC0-24 for Plasma Total EPA + Total DHA
time frame: participants were followed for the duration of study, up to 12 weeks, each treatment having a 4-week duration and a 4-week wash off period in between.
description: AUC0-24: Area under the plasma concentration versus time curve, from time 0 to 24 hours after start of the meal
measure: Baseline-adjusted Cmax for Plasma Total EPA + Total DHA
time frame: participants were followed for the duration of study, up to 12 weeks, each treatment having a 4-week duration and a 4-week wash off period in between.
description: Cmax: Maximum measured plasma concentration over the time span specified
measure: Baseline-adjusted AUC0-24 for Plasma Total EPA
time frame: participants were followed for the duration of study, up to 12 weeks, each treatment having a 4-week duration and a 4-week wash off period in between.
measure: Baseline-adjusted Cmax for Plasma Total EPA
time frame: participants were followed for the duration of study, up to 12 weeks, each treatment having a 4-week duration and a 4-week wash off period in between.
measure: Baseline-adjusted AUC0-24 for Plasma Total DHA
time frame: participants were followed for the duration of study, up to 12 weeks, each treatment having a 4-week duration and a 4-week wash off period in between.
measure: Baseline-adjusted Cmax for Plasma Total DHA
time frame: This is a crossover study with two treatment periods. The estimated treatment effects were based on the within-subject comparison between the two treatments, each having a 4-week duration and a 4-week wash off period in between.
measure: Baseline-adjusted AUC0-24 for Plasma Total DPA
time frame: participants were followed for the duration of study, up to 12 weeks, each treatment having a 4-week duration and a 4-week wash off period in between.
measure: Baseline-adjusted Cmax for Plasma Total DPA
time frame: participants were followed for the duration of study, up to 12 weeks, each treatment having a 4-week duration and a 4-week wash off period in between.
arm group label: E4:L4
arm group type: Active Comparator
description: Crossover Sequence
arm group label: L4:E4
arm group type: Active Comparator
description: Crossover Sequence
arm group label: E2:L4
arm group type: Active Comparator
description: Crossover Sequence
arm group label: L4:E2
arm group type: Active Comparator
description: Crossover Sequence
intervention type: Drug
intervention name: Epanova
arm group label: E2:L4
arm group label: E4:L4
arm group label: L4:E2
arm group label: L4:E4
intervention type: Drug
intervention name: Lovaza
arm group label: E2:L4
arm group label: E4:L4
arm group label: L4:E2
arm group label: L4:E4
criteria: 
gender: All
minimum age: 18 Years
maximum age: 130 Years
healthy volunteers: No
last name: Andrea L Lawless, MD
role: Principal Investigator
affiliation: Biofortis, Inc Addison IL 60101
facility: 
facility: 
facility: 
facility: 
country: Canada
country: United States
responsible party type: Sponsor
mesh term: Pancreatitis
mesh term: Hypertriglyceridemia
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 