<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/NCT02241772</url>
  </required_header>
  <id_info>
    <org_study_id>TA-8995-06</org_study_id>
    <nct_id>NCT02241772</nct_id>
  </id_info>
  <brief_title>A Study on the Effects of TA-8995 on Lp(a) in Subjects With Elevated Lp(a)</brief_title>
  <sponsors>
    <lead_sponsor>
      <agency>Xention Ltd</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Xention Ltd</source>
  <brief_summary>
    <textblock>
      A study in males and females with elevated Lp(a) to look at the effects of TA-8995 on Lp(a)&#xD;
      levels.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>September 2014</start_date>
  <completion_date type="Actual">February 2015</completion_date>
  <primary_completion_date type="Actual">January 2015</primary_completion_date>
  <phase>Phase 1/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>To evaluate the change from baseline in (Lp(a) levels after 12 weeks of treatment with TA-8995.</measure>
    <time_frame>12 weeks</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Number of participants with adverse events</measure>
    <time_frame>12 weeks</time_frame>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">42</enrollment>
  <condition>Elevated Lp(a)</condition>
  <arm_group>
    <arm_group_label>10mg TA-8995</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>10mg TA-8995 once daily</description>
  </arm_group>
  <arm_group>
    <arm_group_label>2.5mg TA-8995</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>2.5mg TA-8995 once daily</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo to TA-8995</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Placebo to TA-8995 once daily.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>TA-8995</intervention_name>
    <arm_group_label>10mg TA-8995</arm_group_label>
    <arm_group_label>2.5mg TA-8995</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <arm_group_label>Placebo to TA-8995</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Male and female (of non-child bearing potential) subjects with elevated Lp(a) levels&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Clinically significant medical history&#xD;
&#xD;
          -  Abnormal laboratory results (other than lipid levels) or vital signs&#xD;
&#xD;
          -  Receiving any other drug therapy&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Herlev Hospital</name>
      <address>
        <city>Herlev</city>
        <zip>DK-2730</zip>
        <country>Denmark</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Denmark</country>
  </location_countries>
  <verification_date>October 2014</verification_date>
  <study_first_submitted>August 20, 2014</study_first_submitted>
  <study_first_submitted_qc>September 12, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 16, 2014</study_first_posted>
  <last_update_submitted>February 12, 2015</last_update_submitted>
  <last_update_submitted_qc>February 12, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">February 16, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <!-- 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/NCT02241772
org study id: TA-8995-06
nct id: NCT02241772
lead sponsor: 
A study in males and females with elevated Lp(a) to look at the effects of TA-8995 on Lp(a)
      levels.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: To evaluate the change from baseline in (Lp(a) levels after 12 weeks of treatment with TA-8995.
time frame: 12 weeks
measure: Number of participants with adverse events
time frame: 12 weeks
arm group label: 10mg TA-8995
arm group type: Experimental
description: 10mg TA-8995 once daily
arm group label: 2.5mg TA-8995
arm group type: Experimental
description: 2.5mg TA-8995 once daily
arm group label: Placebo to TA-8995
arm group type: Placebo Comparator
description: Placebo to TA-8995 once daily.
intervention type: Drug
intervention name: TA-8995
arm group label: 10mg TA-8995
arm group label: 2.5mg TA-8995
intervention type: Drug
intervention name: Placebo
arm group label: Placebo to TA-8995
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: Denmark
responsible party type: Sponsor