<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/NCT01715818</url>
  </required_header>
  <id_info>
    <org_study_id>BC28027</org_study_id>
    <secondary_id>2012-000671-16</secondary_id>
    <nct_id>NCT01715818</nct_id>
  </id_info>
  <brief_title>A Study on The Potential of Aleglitazar to Reduce Cardiovascular Risk in Patients With Stable Cardiovascular Disease and Glucose Abnormalities</brief_title>
  <official_title>A PHASE 3B STUDY TO EVALUATE THE POTENTIAL OF ALEGLITAZAR TO REDUCE CARDIOVASCULAR RISK IN PATIENTS WITH STABLE CARDIOVASCULAR DISEASE AND GLUCOSE ABNORMALITIES</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Hoffmann-La Roche</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Hoffmann-La Roche</source>
  <brief_summary>
    <textblock>
      This randomized, double-blind, placebo-controlled, parallel group, multicenter study will&#xD;
      evaluate the potential of aleglitazar to reduce cardiovascular risk in patients with stable&#xD;
      cardiovascular disease and glucose abnormalities. Patients will be randomized 1:1 to receive&#xD;
      either aleglitazar 150 mcg orally daily or matching placebo.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>December 2012</start_date>
  <completion_date type="Actual">November 2013</completion_date>
  <primary_completion_date type="Actual">November 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>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Time to first occurrence of any component of the composite event (cardiovascular death, non-fatal myocardial infarction (MI), non-fatal stroke) as adjudicated by the Clinical Events Committee (CEC)</measure>
    <time_frame>5 years</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Time to first occurrence of a composite with components as adjudicated by the CEC: cardiovascular death, non-fatal MI and non-fatal stroke (in each of the subgroups with or without evidence of T2D at baseline)</measure>
    <time_frame>5 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to first occurrence of a composite with components as adjudicated by the CEC: all-cause mortality, non-fatal MI and non-fatal stroke (in each of the subgroups with or without evidence of T2D at baseline)</measure>
    <time_frame>5 years</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">1999</enrollment>
  <condition>Cardiovascular Disease, Diabetes Mellitus Type 2</condition>
  <arm_group>
    <arm_group_label>Aleglitazar</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>matching aleglitazar placebo tablet orally daily</description>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>aleglitazar</intervention_name>
    <description>150 mcg orally daily</description>
    <arm_group_label>Aleglitazar</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Male and female patients with established evidence of stable cardiovascular disease&#xD;
             (CVD) defined as at least one of the following groups of criteria (A or B) A. Age &gt;/=&#xD;
             40 years with history with prior CV event of prior myocardial infarction or prior&#xD;
             ischemic stroke (confirmed by brain imaging study), with onset &gt;/= 3 months prior to&#xD;
             randomization and stable in the Investigator's judgment B. Age &gt;/= 55 years with&#xD;
             evidence of CVD (stable in the Investigator's judgment), defined as at least one of&#xD;
             the following: Coronary disease, cerebrovascular disease or peripheral arterial&#xD;
             disease as defined by protocol&#xD;
&#xD;
          -  Patients with glucose abnormalities based on one of the following A-B criteria:&#xD;
&#xD;
        A. Established Type 2 diabetes mellitus (T2D) according to 2010 ADA criteria; treatment may&#xD;
        include diet alone, or any glucose-lowering therapies except for thiazolidinediones (TDZs)&#xD;
        B. No fulfillment of criterion A) but evidence of glucose abnormalities&#xD;
&#xD;
          -  Optimal management of CV risk factors including hypertension and dyslipidemia as&#xD;
             informed by the best evidence and clinical practice guidelines&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Current treatment with a thiazolidinedione (TDZ) or fibrate&#xD;
&#xD;
          -  Prior intolerance to a TDZ or fibrate&#xD;
&#xD;
          -  Previous participation in a trial with aleglitazar&#xD;
&#xD;
          -  Other types of diabetes&#xD;
&#xD;
          -  Inadequate liver, hematologic or renal function&#xD;
&#xD;
          -  Symptomatic heart failure classified as NYHA class II-IV&#xD;
&#xD;
          -  Hospitalization for a primary diagnosis of heart failure in the 12-month period&#xD;
             preceding randomization&#xD;
&#xD;
          -  Peripheral edema which in the judgment of the Investigator in believed to be severe&#xD;
             and of cardiac origin&#xD;
&#xD;
          -  History of surgical coronary revascularization (CABG) less than 5 years prior to&#xD;
             screening, except in cases of subsequent myocardial infarction&#xD;
&#xD;
          -  Currently scheduled for arterial revascularization procedures&#xD;
&#xD;
          -  Systemic corticosteroid therapy for &gt; 2 weeks within 3 months prior to screening&#xD;
&#xD;
          -  Diagnosed or treated malignancy (except for treated basal cell skin cancer, in situ&#xD;
             carcinoma of the cervix, or in situ prostate cancer) within the past 5 years&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>40 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Clinical Trials</last_name>
    <role>Study Director</role>
    <affiliation>Hoffmann-La Roche</affiliation>
  </overall_official>
  <location>
    <facility>
      <address>
        <city>Muscle Shoals</city>
        <state>Alabama</state>
        <zip>35662</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Gilbert</city>
        <state>Arizona</state>
        <zip>85295</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Phoenix</city>
        <state>Arizona</state>
        <zip>85018</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Tucson</city>
        <state>Arizona</state>
        <zip>85724</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Cudahy</city>
        <state>California</state>
        <zip>90201</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Encino</city>
        <state>California</state>
        <zip>91436</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Fresno</city>
        <state>California</state>
        <zip>93720</zip>
        <country>United States</country>
      </address>
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  </location>
  <location>
    <facility>
      <address>
        <city>Fresno</city>
        <state>California</state>
        <zip>93721</zip>
        <country>United States</country>
      </address>
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  </location>
  <location>
    <facility>
      <address>
        <city>Hawaiian Gardens</city>
        <state>California</state>
        <zip>90716</zip>
        <country>United States</country>
      </address>
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  </location>
  <location>
    <facility>
      <address>
        <city>Huntington Beach</city>
        <state>California</state>
        <zip>92646</zip>
        <country>United States</country>
      </address>
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  </location>
  <location>
    <facility>
      <address>
        <city>Lomita</city>
        <state>California</state>
        <zip>90717</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Long Beach</city>
        <state>California</state>
        <zip>90807</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Los Angeles</city>
        <state>California</state>
        <zip>90017</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Los Angeles</city>
        <state>California</state>
        <zip>90036</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Los Angeles</city>
        <state>California</state>
        <zip>90057</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Los Gatos</city>
        <state>California</state>
        <zip>95032</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>North Hollywood</city>
        <state>California</state>
        <zip>91606</zip>
        <country>United States</country>
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  <location>
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        <city>Northridge</city>
        <state>California</state>
        <zip>91325</zip>
        <country>United States</country>
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  <location>
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        <state>California</state>
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        <country>United States</country>
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  <location>
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        <city>Sacramento</city>
        <state>California</state>
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  <location>
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      <address>
        <city>San Diego</city>
        <state>California</state>
        <zip>92103</zip>
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  <location>
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      <address>
        <city>Stockton</city>
        <state>California</state>
        <zip>95207</zip>
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  <location>
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      <address>
        <city>Thousand Oaks</city>
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  <location>
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        <city>Torrance</city>
        <state>California</state>
        <zip>90502</zip>
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  <location>
    <facility>
      <address>
        <city>Tustin</city>
        <state>California</state>
        <zip>92780</zip>
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      </address>
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  <location>
    <facility>
      <address>
        <city>Ventura</city>
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        <zip>90265</zip>
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        <state>Colorado</state>
        <zip>80209</zip>
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        <zip>33012</zip>
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        <zip>33013</zip>
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        <zip>34741</zip>
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        <zip>33140</zip>
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        <zip>33135</zip>
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        <zip>30909</zip>
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        <country>United States</country>
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        <zip>01830</zip>
        <country>United States</country>
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    <facility>
      <address>
        <city>Traverse City</city>
        <state>Michigan</state>
        <zip>49684</zip>
        <country>United States</country>
      </address>
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  </location>
  <location>
    <facility>
      <address>
        <city>Fall Rivers</city>
        <state>Mississippi</state>
        <zip>02720</zip>
        <country>United States</country>
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    </facility>
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  <location>
    <facility>
      <address>
        <city>Kansas City</city>
        <state>Missouri</state>
        <zip>64111</zip>
        <country>United States</country>
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    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Bellevue</city>
        <state>Nebraska</state>
        <zip>68005</zip>
        <country>United States</country>
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  </location>
  <location>
    <facility>
      <address>
        <city>Fremont</city>
        <state>Nebraska</state>
        <zip>68025</zip>
        <country>United States</country>
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  <location>
    <facility>
      <address>
        <city>Las Vegas</city>
        <state>Nevada</state>
        <zip>89106</zip>
        <country>United States</country>
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    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Las Vegas</city>
        <state>Nevada</state>
        <zip>89121</zip>
        <country>United States</country>
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  <location>
    <facility>
      <address>
        <city>Las Vegas</city>
        <state>Nevada</state>
        <zip>89123</zip>
        <country>United States</country>
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  <location>
    <facility>
      <address>
        <city>Elizabeth</city>
        <state>New Jersey</state>
        <zip>07202</zip>
        <country>United States</country>
      </address>
    </facility>
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  <location>
    <facility>
      <address>
        <city>Albany</city>
        <state>New York</state>
        <zip>12206-1098</zip>
        <country>United States</country>
      </address>
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  <location>
    <facility>
      <address>
        <city>North Massapequa</city>
        <state>New York</state>
        <zip>11758</zip>
        <country>United States</country>
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    </facility>
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  <location>
    <facility>
      <address>
        <city>Smithtown</city>
        <state>New York</state>
        <zip>11787</zip>
        <country>United States</country>
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    </facility>
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  <location>
    <facility>
      <address>
        <city>Syracuse</city>
        <state>New York</state>
        <zip>13202</zip>
        <country>United States</country>
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  <location>
    <facility>
      <address>
        <city>Westfield</city>
        <state>New York</state>
        <zip>14787</zip>
        <country>United States</country>
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    </facility>
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  <location>
    <facility>
      <address>
        <city>Elizabeth City</city>
        <state>North Carolina</state>
        <zip>27909</zip>
        <country>United States</country>
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    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Morganton</city>
        <state>North Carolina</state>
        <zip>28655</zip>
        <country>United States</country>
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    </facility>
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  <location>
    <facility>
      <address>
        <city>Raleigh</city>
        <state>North Carolina</state>
        <zip>27609</zip>
        <country>United States</country>
      </address>
    </facility>
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  <location>
    <facility>
      <address>
        <city>Shelby</city>
        <state>North Carolina</state>
        <zip>28150</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Winston-Salem</city>
        <state>North Carolina</state>
        <zip>27103</zip>
        <country>United States</country>
      </address>
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  </location>
  <location>
    <facility>
      <address>
        <city>Fargo</city>
        <state>North Dakota</state>
        <zip>58103</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Akron</city>
        <state>Ohio</state>
        <zip>44313</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Gallipolis</city>
        <state>Ohio</state>
        <zip>45631</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Kettering</city>
        <state>Ohio</state>
        <zip>45429</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Zanesville</city>
        <state>Ohio</state>
        <zip>43701</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Oklahoma City</city>
        <state>Oklahoma</state>
        <zip>73103</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Tulsa</city>
        <state>Oklahoma</state>
        <zip>74104</zip>
        <country>United States</country>
      </address>
    </facility>
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  <location>
    <facility>
      <address>
        <city>Portland</city>
        <state>Oregon</state>
        <zip>97220</zip>
        <country>United States</country>
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  <location>
    <facility>
      <address>
        <city>Beaver</city>
        <state>Pennsylvania</state>
        <zip>15009</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Doylestown</city>
        <state>Pennsylvania</state>
        <zip>18901</zip>
        <country>United States</country>
      </address>
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  <location>
    <facility>
      <address>
        <city>Fleetwood</city>
        <state>Pennsylvania</state>
        <zip>19522</zip>
        <country>United States</country>
      </address>
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  </location>
  <location>
    <facility>
      <address>
        <city>Harleysville</city>
        <state>Pennsylvania</state>
        <zip>19438</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Jersey Shore</city>
        <state>Pennsylvania</state>
        <zip>17740</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Lansdale</city>
        <state>Pennsylvania</state>
        <zip>19446</zip>
        <country>United States</country>
      </address>
    </facility>
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  <location>
    <facility>
      <address>
        <city>Philadelphia</city>
        <state>Pennsylvania</state>
        <zip>19114</zip>
        <country>United States</country>
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  <location>
    <facility>
      <address>
        <city>Pittsburg</city>
        <state>Pennsylvania</state>
        <zip>15202</zip>
        <country>United States</country>
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  <location>
    <facility>
      <address>
        <city>Sellersville</city>
        <state>Pennsylvania</state>
        <zip>18960</zip>
        <country>United States</country>
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  <location>
    <facility>
      <address>
        <city>Uniontown</city>
        <state>Pennsylvania</state>
        <zip>15401</zip>
        <country>United States</country>
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  <location>
    <facility>
      <address>
        <city>Clinton</city>
        <state>South Carolina</state>
        <zip>29325</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Greer</city>
        <state>South Carolina</state>
        <zip>29651</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Murrells Inlet</city>
        <state>South Carolina</state>
        <zip>29576</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Varnville</city>
        <state>South Carolina</state>
        <zip>29944</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Dakota Dunes</city>
        <state>South Dakota</state>
        <zip>57049</zip>
        <country>United States</country>
      </address>
    </facility>
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  <location>
    <facility>
      <address>
        <city>Chattanooga</city>
        <state>Tennessee</state>
        <zip>37404-3230</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Chattanooga</city>
        <state>Tennessee</state>
        <zip>37411</zip>
        <country>United States</country>
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  <location>
    <facility>
      <address>
        <city>Jackson</city>
        <state>Tennessee</state>
        <zip>38305</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Knoxville</city>
        <state>Tennessee</state>
        <zip>27912</zip>
        <country>United States</country>
      </address>
    </facility>
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  <location>
    <facility>
      <address>
        <city>Nashville</city>
        <state>Tennessee</state>
        <zip>37203</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Arlington</city>
        <state>Texas</state>
        <zip>76012</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Corpus Christi</city>
        <state>Texas</state>
        <zip>78404</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Dallas</city>
        <state>Texas</state>
        <zip>75230</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>El Paso</city>
        <state>Texas</state>
        <zip>79925</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77030</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77036</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77074</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Kingwood</city>
        <state>Texas</state>
        <zip>77339</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>McAllen</city>
        <state>Texas</state>
        <zip>78501</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>New Braunfels</city>
        <state>Texas</state>
        <zip>78130</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>North Richland Hills</city>
        <state>Texas</state>
        <zip>76180</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>San Antonio</city>
        <state>Texas</state>
        <zip>78224</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>San Antonio</city>
        <state>Texas</state>
        <zip>78229</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Tyler</city>
        <state>Texas</state>
        <zip>75701</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Bountiful</city>
        <state>Utah</state>
        <zip>84010</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Draper</city>
        <state>Utah</state>
        <zip>84020</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Murray</city>
        <state>Utah</state>
        <zip>84123</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Salt Lake City</city>
        <state>Utah</state>
        <zip>84124</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Burke</city>
        <state>Virginia</state>
        <zip>22015</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Manassas</city>
        <state>Virginia</state>
        <zip>20110</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Suffolk</city>
        <state>Virginia</state>
        <zip>23435</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Port Orchard</city>
        <state>Washington</state>
        <zip>98366</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Spokane</city>
        <state>Washington</state>
        <zip>99207</zip>
        <country>United States</country>
      </address>
    </facility>
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  <location>
    <facility>
      <address>
        <city>Madison</city>
        <state>Wisconsin</state>
        <zip>53719</zip>
        <country>United States</country>
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    </facility>
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  <location>
    <facility>
      <address>
        <city>Caba</city>
        <zip>C1119ACN</zip>
        <country>Argentina</country>
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  </location>
  <location>
    <facility>
      <address>
        <city>Caba</city>
        <zip>C1428DCO</zip>
        <country>Argentina</country>
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  <location>
    <facility>
      <address>
        <city>Camperdown</city>
        <state>New South Wales</state>
        <zip>2050</zip>
        <country>Australia</country>
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    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Gosford</city>
        <state>New South Wales</state>
        <zip>2250</zip>
        <country>Australia</country>
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    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Kogarah</city>
        <state>New South Wales</state>
        <zip>2217</zip>
        <country>Australia</country>
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  <location>
    <facility>
      <address>
        <city>Wollongong</city>
        <state>New South Wales</state>
        <zip>2500</zip>
        <country>Australia</country>
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    </facility>
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  <location>
    <facility>
      <address>
        <city>South Brisbane</city>
        <state>Queensland</state>
        <zip>4101</zip>
        <country>Australia</country>
      </address>
    </facility>
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  <location>
    <facility>
      <address>
        <city>Adelaide</city>
        <state>South Australia</state>
        <zip>5000</zip>
        <country>Australia</country>
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    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Woodville</city>
        <state>South Australia</state>
        <zip>5011</zip>
        <country>Australia</country>
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    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Launceston</city>
        <state>Tasmania</state>
        <zip>7250</zip>
        <country>Australia</country>
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    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Geelong</city>
        <state>Victoria</state>
        <zip>3220</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Heidelberg</city>
        <state>Victoria</state>
        <zip>3081</zip>
        <country>Australia</country>
      </address>
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  </location>
  <location>
    <facility>
      <address>
        <city>Melbourne</city>
        <state>Victoria</state>
        <zip>3004</zip>
        <country>Australia</country>
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  </location>
  <location>
    <facility>
      <address>
        <city>Armadale</city>
        <state>Western Australia</state>
        <zip>6112</zip>
        <country>Australia</country>
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    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Perth</city>
        <state>Western Australia</state>
        <zip>6009</zip>
        <country>Australia</country>
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    </facility>
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  <location>
    <facility>
      <address>
        <city>Braunau</city>
        <zip>5280</zip>
        <country>Austria</country>
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  <location>
    <facility>
      <address>
        <city>Feldkirch</city>
        <zip>6800</zip>
        <country>Austria</country>
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  <location>
    <facility>
      <address>
        <city>Graz</city>
        <zip>8036</zip>
        <country>Austria</country>
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  <location>
    <facility>
      <address>
        <city>Wien</city>
        <zip>1130</zip>
        <country>Austria</country>
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  <location>
    <facility>
      <address>
        <city>Kelowna</city>
        <state>British Columbia</state>
        <zip>V1Y 1E4</zip>
        <country>Canada</country>
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  </location>
  <location>
    <facility>
      <address>
        <city>Surrey</city>
        <state>British Columbia</state>
        <zip>V3V 1Z2</zip>
        <country>Canada</country>
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  <location>
    <facility>
      <address>
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        <state>Manitoba</state>
        <zip>R3E 3P4</zip>
        <country>Canada</country>
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  <location>
    <facility>
      <address>
        <city>Bathurst</city>
        <state>New Brunswick</state>
        <zip>E2A 4X7</zip>
        <country>Canada</country>
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  <location>
    <facility>
      <address>
        <city>Cambridge</city>
        <state>Ontario</state>
        <zip>N1R 6V6</zip>
        <country>Canada</country>
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  <location>
    <facility>
      <address>
        <city>Collingwood</city>
        <state>Ontario</state>
        <zip>L9Y 1W3</zip>
        <country>Canada</country>
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  <location>
    <facility>
      <address>
        <city>Hamilton</city>
        <state>Ontario</state>
        <zip>L8L 2X2</zip>
        <country>Canada</country>
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  <location>
    <facility>
      <address>
        <city>London</city>
        <state>Ontario</state>
        <zip>N5W 6A2</zip>
        <country>Canada</country>
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  <location>
    <facility>
      <address>
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        <state>Ontario</state>
        <zip>N6G 0J4</zip>
        <country>Canada</country>
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  <location>
    <facility>
      <address>
        <city>New Market</city>
        <state>Ontario</state>
        <zip>L3Y 5G8</zip>
        <country>Canada</country>
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  </location>
  <location>
    <facility>
      <address>
        <city>Mortimer</city>
        <zip>RG7 3SQ</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Reading</city>
        <zip>RG2 0TG</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Soham, Ely</city>
        <zip>CB7 5JD</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Argentina</country>
    <country>Australia</country>
    <country>Austria</country>
    <country>Canada</country>
    <country>Chile</country>
    <country>Colombia</country>
    <country>Czech Republic</country>
    <country>Estonia</country>
    <country>Germany</country>
    <country>Hungary</country>
    <country>Israel</country>
    <country>Italy</country>
    <country>Japan</country>
    <country>Korea, Republic of</country>
    <country>Latvia</country>
    <country>Lithuania</country>
    <country>Malaysia</country>
    <country>Mexico</country>
    <country>Poland</country>
    <country>Romania</country>
    <country>Russian Federation</country>
    <country>South Africa</country>
    <country>Spain</country>
    <country>Sweden</country>
    <country>Thailand</country>
    <country>United Kingdom</country>
    <country>United States</country>
  </location_countries>
  <removed_countries>
    <country>Brazil</country>
    <country>China</country>
    <country>Finland</country>
    <country>France</country>
    <country>India</country>
    <country>Indonesia</country>
    <country>Peru</country>
    <country>Philippines</country>
    <country>Ukraine</country>
  </removed_countries>
  <verification_date>November 2016</verification_date>
  <study_first_submitted>October 25, 2012</study_first_submitted>
  <study_first_submitted_qc>October 25, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 29, 2012</study_first_posted>
  <last_update_submitted>November 1, 2016</last_update_submitted>
  <last_update_submitted_qc>November 1, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">November 2, 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>Cardiovascular Diseases</mesh_term>
    <mesh_term>Diabetes Mellitus, Type 2</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/NCT01715818
org study id: BC28027
secondary id: 2012-000671-16
nct id: NCT01715818
lead sponsor: 
This randomized, double-blind, placebo-controlled, parallel group, multicenter study will
      evaluate the potential of aleglitazar to reduce cardiovascular risk in patients with stable
      cardiovascular disease and glucose abnormalities. Patients will be randomized 1:1 to receive
      either aleglitazar 150 mcg orally daily or matching placebo.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Investigator)
measure: Time to first occurrence of any component of the composite event (cardiovascular death, non-fatal myocardial infarction (MI), non-fatal stroke) as adjudicated by the Clinical Events Committee (CEC)
time frame: 5 years
measure: Time to first occurrence of a composite with components as adjudicated by the CEC: cardiovascular death, non-fatal MI and non-fatal stroke (in each of the subgroups with or without evidence of T2D at baseline)
time frame: 5 years
measure: Time to first occurrence of a composite with components as adjudicated by the CEC: all-cause mortality, non-fatal MI and non-fatal stroke (in each of the subgroups with or without evidence of T2D at baseline)
time frame: 5 years
arm group label: Aleglitazar
arm group type: Experimental
arm group label: Placebo
arm group type: Placebo Comparator
intervention type: Drug
intervention name: Placebo
description: matching aleglitazar placebo tablet orally daily
arm group label: Placebo
intervention type: Drug
intervention name: aleglitazar
description: 150 mcg orally daily
arm group label: Aleglitazar
criteria: 
gender: All
minimum age: 40 Years
maximum age: N/A
healthy volunteers: No
last name: Clinical Trials
role: Study Director
affiliation: Hoffmann-La Roche
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country: Argentina
country: Australia
country: Austria
country: Canada
country: Chile
country: Colombia
country: Czech Republic
country: Estonia
country: Germany
country: Hungary
country: Israel
country: Italy
country: Japan
country: Korea, Republic of
country: Latvia
country: Lithuania
country: Malaysia
country: Mexico
country: Poland
country: Romania
country: Russian Federation
country: South Africa
country: Spain
country: Sweden
country: Thailand
country: United Kingdom
country: United States
country: Brazil
country: China
country: Finland
country: France
country: India
country: Indonesia
country: Peru
country: Philippines
country: Ukraine
responsible party type: Sponsor
mesh term: Cardiovascular Diseases
mesh term: Diabetes Mellitus, Type 2