<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/NCT01691495</url>
  </required_header>
  <id_info>
    <org_study_id>115280</org_study_id>
    <nct_id>NCT01691495</nct_id>
  </id_info>
  <brief_title>ARIXTRA® Adherence in SVT Patients.</brief_title>
  <official_title>ARIXTRA® Physician Adherence to the Prescribing Information in Isolated Superficial Vein Thrombosis (SVT) Patients.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>GlaxoSmithKline</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>GlaxoSmithKline</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Fondaparinux is an anticoagulant used in the prevention and treatment of thromboembolic&#xD;
      disease. It has recently been approved in the European Union (EU) for the treatment of&#xD;
      patients with isolated superficial vein thrombosis (SVT), i.e. without concomitant deep vein&#xD;
      thrombosis (DVT), of the lower limbs. As part of EU approval, GlaxoSmithKline (GSK) committed&#xD;
      to evaluate physicians' adherence to fondaparinux prescribing information regarding proper&#xD;
      diagnosis and dosing for the treatment of SVT.&#xD;
&#xD;
      The primary objective is to evaluate physicians' adherence to fondaparinux prescribing&#xD;
      information for the treatment of patients with SVT without concomitant DVT.&#xD;
&#xD;
      The study is designed as a non-interventional, retrospective chart review of patients&#xD;
      prescribed fondaparinux to treat their SVT. The study will be conducted in several EU&#xD;
      countries.&#xD;
&#xD;
      ARIXTRA® is a registered trademark of the GlaxoSmithKline group of companies.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>October 2012</start_date>
  <completion_date type="Actual">August 2014</completion_date>
  <primary_completion_date type="Actual">August 2014</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <time_perspective>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>The primary outcome will be a measure of physician adherence.</measure>
    <time_frame>2</time_frame>
    <description>adherence described as the percentage of patients for whom both an ultrasound (or other objective measure) was performed in order to rule out concomitant DVT prior to patients commencing fondaparinux</description>
  </primary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">1</enrollment>
  <condition>Thrombosis, Venous</condition>
  <arm_group>
    <arm_group_label>Superficial Vein Thrombosis (SVT)</arm_group_label>
    <description>A representative of geographical regions of patients with Superficial Vein Thrombosis (SVT) who live in several EU countries.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Fondaparinux</intervention_name>
    <description>Physician adherence study to Fondaparinux prescribing information for patients with Superficial Vein Thrombosis (SVT) of the lower limbs</description>
    <arm_group_label>Superficial Vein Thrombosis (SVT)</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Up to 12 clinical sites representative of geographical regions of several EU countries,&#xD;
        targeting physician adherence to prescribing in approximately 840 patients with SVT.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Diagnosis of SVT&#xD;
&#xD;
          -  Prescribed fondaparinux for the treatment of SVT&#xD;
&#xD;
          -  Age 18 years or older&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients should not have been involved in any clinical trial that could influence SVT&#xD;
             treatment during the observational period.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>GSK Clinical Trials</last_name>
    <role>Study Director</role>
    <affiliation>GlaxoSmithKline</affiliation>
  </overall_official>
  <verification_date>March 2015</verification_date>
  <study_first_submitted>September 20, 2012</study_first_submitted>
  <study_first_submitted_qc>September 20, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 24, 2012</study_first_posted>
  <last_update_submitted>March 26, 2015</last_update_submitted>
  <last_update_submitted_qc>March 26, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">March 27, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Physician Adherence</keyword>
  <keyword>superficial vein thrombosis</keyword>
  <keyword>Fondaparinux</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Thrombosis</mesh_term>
    <mesh_term>Venous Thrombosis</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>PENTA</mesh_term>
    <mesh_term>Fondaparinux</mesh_term>
  </intervention_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/NCT01691495
org study id: 115280
nct id: NCT01691495
lead sponsor: 
has dmc: No
Fondaparinux is an anticoagulant used in the prevention and treatment of thromboembolic
      disease. It has recently been approved in the European Union (EU) for the treatment of
      patients with isolated superficial vein thrombosis (SVT), i.e. without concomitant deep vein
      thrombosis (DVT), of the lower limbs. As part of EU approval, GlaxoSmithKline (GSK) committed
      to evaluate physicians' adherence to fondaparinux prescribing information regarding proper
      diagnosis and dosing for the treatment of SVT.

      The primary objective is to evaluate physicians' adherence to fondaparinux prescribing
      information for the treatment of patients with SVT without concomitant DVT.

      The study is designed as a non-interventional, retrospective chart review of patients
      prescribed fondaparinux to treat their SVT. The study will be conducted in several EU
      countries.

      ARIXTRA® is a registered trademark of the GlaxoSmithKline group of companies.
time perspective: Retrospective
measure: The primary outcome will be a measure of physician adherence.
time frame: 2
description: adherence described as the percentage of patients for whom both an ultrasound (or other objective measure) was performed in order to rule out concomitant DVT prior to patients commencing fondaparinux
arm group label: Superficial Vein Thrombosis (SVT)
description: A representative of geographical regions of patients with Superficial Vein Thrombosis (SVT) who live in several EU countries.
intervention type: Drug
intervention name: Fondaparinux
description: Physician adherence study to Fondaparinux prescribing information for patients with Superficial Vein Thrombosis (SVT) of the lower limbs
arm group label: Superficial Vein Thrombosis (SVT)
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: GSK Clinical Trials
role: Study Director
affiliation: GlaxoSmithKline
responsible party type: Sponsor
mesh term: Thrombosis
mesh term: Venous Thrombosis
mesh term: PENTA
mesh term: Fondaparinux