<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/NCT01725646</url>
  </required_header>
  <id_info>
    <org_study_id>OM3-99001</org_study_id>
    <nct_id>NCT01725646</nct_id>
  </id_info>
  <brief_title>An Efficacy and Safety Study of Omacor® in Taiwanese Hypertriglyceridemic Patients</brief_title>
  <official_title>A Randomized, Double-blinded, Placebo-controlled Study to Assess the Efficacy and Safety of Omacor® in Taiwanese Hypertriglyceridemic Patients</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Excelsior</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Excelsior</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      1. Evaluation of the efficacy of Omacor® in Taiwanese hypertriglyceridemia patients&#xD;
&#xD;
        2. Evaluation of the safety of Omacor® in Taiwanese hypertriglyceridemia patients&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The primary end point is to evaluate the efficacy and safety of Omacor in Taiwanese&#xD;
      hypertriglyceridemia patients.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>July 2011</start_date>
  <completion_date type="Actual">August 2013</completion_date>
  <primary_completion_date type="Actual">July 2013</primary_completion_date>
  <phase>Phase 3</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>Change in Triglycerides from baseline</measure>
    <time_frame>baseline and 8 weeks</time_frame>
  </primary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">253</enrollment>
  <condition>Hypertriglyceridemia</condition>
  <arm_group>
    <arm_group_label>Omacor® 4 g</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Subjects in this group will take 4 g of Omacor® everyday.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Omacor® 2 g</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Subjects in this group will take 2 g of Omacor® and 2 g of placebo everyday.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Subjects in this group will take 4 g of placebo everyday.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Omacor®</intervention_name>
    <description>Subjects in 4 g and 2 g Omacor® will take this drug</description>
    <arm_group_label>Omacor® 2 g</arm_group_label>
    <arm_group_label>Omacor® 4 g</arm_group_label>
    <other_name>Omega-3-acid ethyl ester 90</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Subjects in placebo group will take this drug</description>
    <arm_group_label>Placebo</arm_group_label>
    <other_name>Olive oil</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patient has fasting serum TG ≥ 200 mg/dL but no more than 1000 mg/dL&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients had a history of pancreatitis or considered to be at risk of developing&#xD;
             pancreatitis&#xD;
&#xD;
          -  Patient had history of a severe cardiovascular event or a revascularization procedure&#xD;
             within 6 months prior to randomization&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>79 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Chuen-Den Tseng, M.D., PhD.</last_name>
    <role>Principal Investigator</role>
    <affiliation>NTUH</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Taichung Veterans General Hospital</name>
      <address>
        <city>Taichung</city>
        <zip>40705</zip>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>National Cheng Kung University Hospital</name>
      <address>
        <city>Tainan</city>
        <zip>704</zip>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>National Taiwan University Hospital</name>
      <address>
        <city>Taipei</city>
        <zip>100</zip>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Taipei Veterans General Hospital</name>
      <address>
        <city>Taipei</city>
        <zip>11217</zip>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Taiwan</country>
  </location_countries>
  <verification_date>May 2014</verification_date>
  <study_first_submitted>October 29, 2012</study_first_submitted>
  <study_first_submitted_qc>November 13, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 14, 2012</study_first_posted>
  <last_update_submitted>May 16, 2014</last_update_submitted>
  <last_update_submitted_qc>May 16, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">May 19, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Hypertriglyceridemia, omega-3-acid ethyl ester</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hypertriglyceridemia</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</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/NCT01725646
org study id: OM3-99001
nct id: NCT01725646
lead sponsor: 
has dmc: No
1. Evaluation of the efficacy of Omacor® in Taiwanese hypertriglyceridemia patients

        2. Evaluation of the safety of Omacor® in Taiwanese hypertriglyceridemia patients
The primary end point is to evaluate the efficacy and safety of Omacor in Taiwanese
      hypertriglyceridemia patients.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Change in Triglycerides from baseline
time frame: baseline and 8 weeks
arm group label: Omacor® 4 g
arm group type: Active Comparator
description: Subjects in this group will take 4 g of Omacor® everyday.
arm group label: Omacor® 2 g
arm group type: Active Comparator
description: Subjects in this group will take 2 g of Omacor® and 2 g of placebo everyday.
arm group label: Placebo
arm group type: Placebo Comparator
description: Subjects in this group will take 4 g of placebo everyday.
intervention type: Drug
intervention name: Omacor®
description: Subjects in 4 g and 2 g Omacor® will take this drug
arm group label: Omacor® 2 g
arm group label: Omacor® 4 g
other name: Omega-3-acid ethyl ester 90
intervention type: Drug
intervention name: Placebo
description: Subjects in placebo group will take this drug
arm group label: Placebo
other name: Olive oil
criteria: 
gender: All
minimum age: 20 Years
maximum age: 79 Years
healthy volunteers: No
last name: Chuen-Den Tseng, M.D., PhD.
role: Principal Investigator
affiliation: NTUH
facility: 
facility: 
facility: 
facility: 
country: Taiwan
responsible party type: Sponsor
mesh term: Hypertriglyceridemia