<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/NCT01674712</url>
  </required_header>
  <id_info>
    <org_study_id>M13-377</org_study_id>
    <secondary_id>2011-005924-16</secondary_id>
    <nct_id>NCT01674712</nct_id>
  </id_info>
  <brief_title>A 12-week Study to Compare the Efficacy and Safety of Fixed Combinations of Fenofibrate/Simvastatin 145/20mg and Fenofibrate/Simvastatin 145/40mg Tablets Versus Fenofibrate or Simvastatin Monotherapies in Subjects With Abnormal Blood Levels of Fats (Lipids) and at High Risk of Cardiovascular Disease</brief_title>
  <official_title>A 12-week, Double-blind, Randomized Study to Compare the Efficacy and Safety of Fixed Combinations of Fenofibrate / Simvastatin 145/20mg and Fenofibrate / Simvastatin 145/40mg Tablets vs. Matching Monotherapies in Dyslipidemic Subjects at High Risk of Cardiovascular Disease.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Abbott</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Abbott</source>
  <brief_summary>
    <textblock>
      This is a double-blind, randomized study designed to compare the efficacy and safety of two&#xD;
      fixed combinations of fenofibrate / simvastatin 145/20 mg and fenofibrate / simvastatin&#xD;
      145/40 mg tablets vs. matching monotherapies in subjects with abnormal fat (lipids) in the&#xD;
      blood and at high risk of cardiovascular disease. Fenofibrate is a treatment that lowers fat&#xD;
      in blood. It is prescribed in patients with high levels of triglycerides (TG). The drug has&#xD;
      been marketed in more than 80 countries since 1975. Simvastatin is also used for the&#xD;
      treatment of patients with a high level of cholesterol. These have also been marketed&#xD;
      worldwide for more than 20 years. It is important to treat high levels of fats in the blood&#xD;
      because it has been shown that even mildly elevated level of lipids in the blood can lead to&#xD;
      diseases of the blood vessels. It has been shown in several studies and in clinical practice&#xD;
      that the combination of fenofibrate plus simvastatin can lead to improved effects on blood&#xD;
      fats, compared to treatment with simvastatin or fenofibrate alone. The main objective of the&#xD;
      study is to compare the efficacy of the two fixed-combinations (FC) -fenofibrate/simvastatin&#xD;
      145/20 mg tablet and fenofibrate/simvastatin 145/40 mg tablet in reducing TG and increasing&#xD;
      high density lipoprotein cholesterol (HDL-C) versus simvastatin 20 mg or 40 mg, and in&#xD;
      reducing low density lipoprotein cholesterol (LDL-C) versus fenofibrate 145 mg.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>June 2012</start_date>
  <completion_date type="Actual">October 2013</completion_date>
  <primary_completion_date type="Actual">October 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>Percentage of Change of TG (Triglyceride)</measure>
    <time_frame>from baseline to 12 weeks of treatment</time_frame>
    <description>Collection and measurement of blood samples.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Percentage of Change of HDL-C (High Density Lipoprotein Cholesterol)</measure>
    <time_frame>from baseline to 12 weeks of treatment</time_frame>
    <description>Collection and measurement of blood samples.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Percentage of Change of LDL-C (Low Density Lipoprotein Cholesterol)</measure>
    <time_frame>from baseline to 12 weeks of treatment</time_frame>
    <description>Collection and measurement of blood samples.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Percentage of Non-HDL (High Density Lipoprotein)-C From Baseline</measure>
    <time_frame>12 weeks</time_frame>
    <description>Collection and measurement of blood samples</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of TC (Triglyceride) From Baseline</measure>
    <time_frame>12 weeks</time_frame>
    <description>Collection and measurement of blood samples</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Apolipoprotein AI From Baseline</measure>
    <time_frame>12 weeks</time_frame>
    <description>Collection and measurement of blood samples</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Apolipoprotein B From Baseline</measure>
    <time_frame>12 weeks</time_frame>
    <description>Collection and measurement of blood samples</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of High-sensitivity C-reactive Protein (hsCRP) From Baseline</measure>
    <time_frame>12 weeks</time_frame>
    <description>Collection and measurement of blood samples</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Subjects Meeting Target Levels of Lipids (According to Very High or High Risk)</measure>
    <time_frame>12 weeks</time_frame>
    <description>Collection and measurement of blood samples</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Adverse Events</measure>
    <time_frame>12 weeks</time_frame>
    <description>Collection and measurement of blood samples</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Creatine Kinase (CK)</measure>
    <time_frame>12 weeks</time_frame>
    <description>Collection and measurement of blood samples</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Alanine Aminotransferase (ALT)</measure>
    <time_frame>12 weeks</time_frame>
    <description>Collection and measurement of blood samples</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Plasma Creatinine</measure>
    <time_frame>12 weeks</time_frame>
    <description>Collection and measurement of blood samples</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Total Bilirubin</measure>
    <time_frame>12 weeks</time_frame>
    <description>Collection and measurement of blood samples</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cystatin C</measure>
    <time_frame>12 weeks</time_frame>
    <description>Collection and measurement of blood samples</description>
  </secondary_outcome>
  <number_of_arms>5</number_of_arms>
  <enrollment type="Actual">575</enrollment>
  <condition>Dyslipidemia</condition>
  <arm_group>
    <arm_group_label>Fenofibrate/simvastatin 145/20 mg</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Simvastatin 20 mg</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Fenofibrate 145 mg</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Fenofibrate/simvastatin 145/40 mg</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Simvastatin 40 mg</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Fixed Combination of Fenofibrate/simvastatin 145/20 mg</intervention_name>
    <description>Fenofibrate/simvastatin oval biconvex film-coated tablet, 145 mg / 20 mg, once daily, 12 weeks</description>
    <arm_group_label>Fenofibrate/simvastatin 145/20 mg</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Simvastatin 20 mg</intervention_name>
    <description>Simvastatin generic tablet over-encapsulated, 20 mg, once daily, 12 weeks</description>
    <arm_group_label>Simvastatin 20 mg</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Fenofibrate 145 mg</intervention_name>
    <description>Fenofibrate, tablet, 145 mg, once daily, 12 weeks</description>
    <arm_group_label>Fenofibrate 145 mg</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Fixed Combination of Fenofibrate/simvastatin 145/40 mg</intervention_name>
    <description>Fenofibrate/simvastatin film-coated tablet 145 mg / 40 mg, once daily, 12 weeks</description>
    <arm_group_label>Fenofibrate/simvastatin 145/40 mg</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Simvastatin 40 mg</intervention_name>
    <description>simvastatin, generic tablet over-encapsulated, 40 mg, once daily, 12 weeks</description>
    <arm_group_label>Simvastatin 40 mg</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Either gender (tentatively 50 percent females to be included and if of childbearing&#xD;
             potential she must agree to use medically acceptable methods of contraception from the&#xD;
             time of signing the informed consent until 7 days following administration of the last&#xD;
             treatment or dose of study medication). Accepted contraceptive methods are implants,&#xD;
             injectables, combined oral contraceptives, intra-uterine device or sexual abstinence.&#xD;
&#xD;
          2. between 18 (inclusive) and 80 years&#xD;
&#xD;
          3. With mixed dyslipidemia with fasting lipid results of a blood sample taken at&#xD;
             inclusion and after at least 3 months of any statin monotherapy (excluding simvastatin&#xD;
             80 mg, atorvastatin 40 mg and 80 mg, rosuvastatin 20 mg and 40 mg):&#xD;
&#xD;
               -  TG higher than/equal to 1.71 mmol/L (higher than/equal to 150 mg/dL) and&#xD;
&#xD;
               -  LDL-C higher or equal to 1.81 mmol/L (higher or equal 70 mg/dL) but smaller&#xD;
                  than/equal to 3.36 mmol/L (smaller than/equal to 130 mg/dL)&#xD;
&#xD;
          4. High risk or very high risk based on known CardioVascular Disease (CVD) or type 2&#xD;
             diabetes or type 1 diabetes with microalbuminuria or a Systematic Coronary Risk&#xD;
             Estimation (SCORE) chart risk ≥ 5percent&#xD;
&#xD;
          5. Aspartate aminotransferase and/or alanine aminotransferase smaller than/equal to 2&#xD;
             times the Upper Normal of Limit (UNL)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Known hypersensitivity to fibrates or simvastatin or known photoallergic or phototoxic&#xD;
             reactions under treatment with fibrates or ketoprofen or known allergic reactions&#xD;
             caused by peanuts, peanuts or arachis oil or soy lecithin, or related products,&#xD;
&#xD;
          2. Pregnant or lactating women,&#xD;
&#xD;
          3. Unable or unwilling to comply with the protocol and the recommended diet,&#xD;
&#xD;
          4. Likely to withdraw from the study before its completion,&#xD;
&#xD;
          5. Having received an investigational drug or vaccine in the last 30 days before date of&#xD;
             inclusion, or still participating in such a trial at Visit 1&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Jean-Claude Ansquer, MD</last_name>
    <role>Study Director</role>
    <affiliation>Abbott</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Site Reference ID/Investigator# 77961</name>
      <address>
        <city>Buenos Aires</city>
        <zip>7600</zip>
        <country>Argentina</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site Reference ID/Investigator# 77957</name>
      <address>
        <city>Buenos Aires</city>
        <zip>B1605DSX</zip>
        <country>Argentina</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site Reference ID/Investigator# 77958</name>
      <address>
        <city>Buenos Aires</city>
        <zip>B1657BHD</zip>
        <country>Argentina</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site Reference ID/Investigator# 77960</name>
      <address>
        <city>Buenos Aires</city>
        <zip>B1722COV</zip>
        <country>Argentina</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site Reference ID/Investigator# 77959</name>
      <address>
        <city>Buenos Aires</city>
        <zip>B1878GEG</zip>
        <country>Argentina</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site Reference ID/Investigator# 77969</name>
      <address>
        <city>Buenos Aires</city>
        <zip>B2800DGH</zip>
        <country>Argentina</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site Reference ID/Investigator# 77967</name>
      <address>
        <city>Buenos Aires</city>
        <zip>C1179AAB</zip>
        <country>Argentina</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site Reference ID/Investigator# 77968</name>
      <address>
        <city>Buenos Aires</city>
        <zip>C1181ACK</zip>
        <country>Argentina</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site Reference ID/Investigator# 77965</name>
      <address>
        <city>Buenos Aires</city>
        <zip>C1405BCH</zip>
        <country>Argentina</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site Reference ID/Investigator# 77956</name>
      <address>
        <city>Buenos Aires</city>
        <country>Argentina</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site Reference ID/Investigator# 77966</name>
      <address>
        <city>Cipolletti - Rio Negro</city>
        <zip>8324</zip>
        <country>Argentina</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site Reference ID/Investigator# 77955</name>
      <address>
        <city>Santa Fe</city>
        <zip>3000</zip>
        <country>Argentina</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site Reference ID/Investigator# 77962</name>
      <address>
        <city>Santa Fe</city>
        <zip>3000</zip>
        <country>Argentina</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site Reference ID/Investigator# 77964</name>
      <address>
        <city>Santa Fe</city>
        <zip>S2000DSV</zip>
        <country>Argentina</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site Reference ID/Investigator# 77963</name>
      <address>
        <city>Tucuman</city>
        <zip>4000JCU</zip>
        <country>Argentina</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site reference ID/Investigator # 99617</name>
      <address>
        <city>Benatky nad Jizerou</city>
        <zip>294 71</zip>
        <country>Czech Republic</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site Reference ID/Investigator# 80097</name>
      <address>
        <city>Brno</city>
        <zip>656 91</zip>
        <country>Czech Republic</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site reference ID/Investigator # 102335</name>
      <address>
        <city>Brno</city>
        <zip>65691</zip>
        <country>Czech Republic</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site Reference ID/Investigator# 80094</name>
      <address>
        <city>Prague 10</city>
        <zip>108 00</zip>
        <country>Czech Republic</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site Reference ID/Investigator# 80095</name>
      <address>
        <city>Prague 4</city>
        <zip>14059</zip>
        <country>Czech Republic</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site Reference ID/Investigator# 80093</name>
      <address>
        <city>Praha 8</city>
        <zip>18081</zip>
        <country>Czech Republic</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site Reference ID/Investigator# 80098</name>
      <address>
        <city>Teplice</city>
        <zip>415 01</zip>
        <country>Czech Republic</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site Reference ID/Investigator# 80096</name>
      <address>
        <city>Usti nad Labem</city>
        <zip>40113</zip>
        <country>Czech Republic</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site Reference ID/Investigator# 80099</name>
      <address>
        <city>Znojmo</city>
        <zip>669 02</zip>
        <country>Czech Republic</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site reference ID/Investigator # 97356</name>
      <address>
        <city>Berlin</city>
        <zip>10117</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site Reference ID/Investigator# 90673</name>
      <address>
        <city>Berlin</city>
        <zip>10249</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site Reference ID/Investigator# 80100</name>
      <address>
        <city>Berlin</city>
        <zip>12351</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site reference ID/Investigator # 97357</name>
      <address>
        <city>Berlin</city>
        <zip>13125</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site reference ID/Investigator # 102017</name>
      <address>
        <city>Dortmund</city>
        <zip>44137</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site reference ID/Investigator # 99876</name>
      <address>
        <city>Dresden</city>
        <zip>01069</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site Reference ID/Investigator# 80102</name>
      <address>
        <city>Dusseldorf</city>
        <zip>40597</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site Reference ID/Investigator# 80104</name>
      <address>
        <city>Essen</city>
        <zip>45355</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site Reference ID/Investigator# 80103</name>
      <address>
        <city>Essen</city>
        <zip>45359</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site Reference ID/Investigator# 80105</name>
      <address>
        <city>Frankfurt</city>
        <zip>60594</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site Reference ID/Investigator# 80101</name>
      <address>
        <city>Goch</city>
        <zip>47574</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site reference ID/Investigator # 99902</name>
      <address>
        <city>Hamburg</city>
        <zip>20253</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site reference ID/Investigator # 102015</name>
      <address>
        <city>Karlsruhe</city>
        <zip>76199</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site reference ID/Investigator # 102016</name>
      <address>
        <city>Koeln</city>
        <zip>51069</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site Reference ID/Investigator# 77970</name>
      <address>
        <city>Guadalajara, Jal.</city>
        <zip>C.P. 44130</zip>
        <country>Mexico</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site Reference ID/Investigator# 77973</name>
      <address>
        <city>Mexico D.F.</city>
        <zip>C.P. 06600</zip>
        <country>Mexico</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site Reference ID/Investigator# 77972</name>
      <address>
        <city>Mexico D.F.</city>
        <zip>C.P. 11850</zip>
        <country>Mexico</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site Reference ID/Investigator# 77974</name>
      <address>
        <city>Zapopan</city>
        <zip>45200</zip>
        <country>Mexico</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site Reference ID/Investigator# 80111</name>
      <address>
        <city>Gdansk</city>
        <zip>80-952</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site Reference ID/Investigator# 80112</name>
      <address>
        <city>Gdansk</city>
        <zip>80-952</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site Reference ID/Investigator# 80110</name>
      <address>
        <city>Gdynia</city>
        <zip>81-423</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site Reference ID/Investigator# 80106</name>
      <address>
        <city>Katowice</city>
        <zip>40-954</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site Reference ID/Investigator# 80109</name>
      <address>
        <city>Plock</city>
        <zip>09-400</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site Reference ID/Investigator# 80108</name>
      <address>
        <city>Skierniewice</city>
        <zip>96-100</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site Reference ID/Investigator# 80107</name>
      <address>
        <city>Warsaw</city>
        <zip>01-868</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site reference ID/Investigator # 80115</name>
      <address>
        <city>Bucharest</city>
        <zip>10242</zip>
        <country>Romania</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site Reference ID/Investigator# 80114</name>
      <address>
        <city>Bucharest</city>
        <zip>11172</zip>
        <country>Romania</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site Reference ID/Investigator# 80117</name>
      <address>
        <city>Bucharest</city>
        <zip>11794</zip>
        <country>Romania</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site Reference ID/Investigator# 80116</name>
      <address>
        <city>Bucharest</city>
        <zip>20054</zip>
        <country>Romania</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site Reference ID/Investigator# 80119</name>
      <address>
        <city>Bucharest</city>
        <zip>22328</zip>
        <country>Romania</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site Reference ID/Investigator# 80113</name>
      <address>
        <city>Bucharest</city>
        <zip>42122</zip>
        <country>Romania</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site Reference ID/Investigator# 80118</name>
      <address>
        <city>Iasi</city>
        <zip>700547</zip>
        <country>Romania</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site Reference ID/Investigator# 80120</name>
      <address>
        <city>Kemerovo</city>
        <zip>650002</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site Reference ID/Investigator# 80135</name>
      <address>
        <city>Moscow</city>
        <zip>119435</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site Reference ID/Investigator# 80137</name>
      <address>
        <city>Moscow</city>
        <zip>119620</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site Reference ID/Investigator# 80124</name>
      <address>
        <city>Moscow</city>
        <zip>119991</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site Reference ID/Investigator# 80127</name>
      <address>
        <city>Moscow</city>
        <zip>125284</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site Reference ID/Investigator# 80122</name>
      <address>
        <city>Novosibirsk</city>
        <zip>630008</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site Reference ID/Investigator# 80121</name>
      <address>
        <city>Novosibirsk</city>
        <zip>630047</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site Reference ID/Investigator# 80133</name>
      <address>
        <city>Novosibirsk</city>
        <zip>630068</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site reference ID/Investigator # 80134</name>
      <address>
        <city>St. Petersburg</city>
        <zip>194156</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site reference ID/Investigator # 80126</name>
      <address>
        <city>St. Petersburg</city>
        <zip>197022</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site reference ID/Investigator # 80128</name>
      <address>
        <city>St. Petersburg</city>
        <zip>197022</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site Reference ID/Investigator# 80136</name>
      <address>
        <city>St. Petersburg</city>
        <zip>199106</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site Reference ID/Investigator# 80125</name>
      <address>
        <city>Yaroslavl</city>
        <zip>150010</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Argentina</country>
    <country>Czech Republic</country>
    <country>Germany</country>
    <country>Mexico</country>
    <country>Poland</country>
    <country>Romania</country>
    <country>Russian Federation</country>
  </location_countries>
  <verification_date>November 2014</verification_date>
  <study_first_submitted>June 26, 2012</study_first_submitted>
  <study_first_submitted_qc>August 27, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 29, 2012</study_first_posted>
  <results_first_submitted>October 27, 2014</results_first_submitted>
  <results_first_submitted_qc>October 27, 2014</results_first_submitted_qc>
  <results_first_posted type="Estimate">October 30, 2014</results_first_posted>
  <last_update_submitted>November 24, 2014</last_update_submitted>
  <last_update_submitted_qc>November 24, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">December 11, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Fibrates</keyword>
  <keyword>Dyslipidemia</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Cardiovascular Diseases</mesh_term>
    <mesh_term>Dyslipidemias</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Simvastatin</mesh_term>
    <mesh_term>Fenofibrate</mesh_term>
  </intervention_browse>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Fenofibrate/Simvastatin 145/20 mg</title>
          <description>Fenofibrate/simvastatin 145/20 mg: Fenofibrate/simvastatin oval biconvex film-coated tablet, 145 mg / 20 mg, once daily, 12 weeks</description>
        </group>
        <group group_id="P2">
          <title>Simvastatin 20 mg</title>
          <description>Simvastatin 20 mg: Simvastatin generic tablet over-encapsulated, 20 mg, once daily, 12 weeks</description>
        </group>
        <group group_id="P3">
          <title>Fenofibrate/Simvastatin 145/40 mg</title>
          <description>Fenofibrate/simvastatin 145/40 mg: Fenofibrate/simvastatin film-coated tablet 145 mg / 40 mg, once daily, 12 weeks</description>
        </group>
        <group group_id="P4">
          <title>Simvastatin 40 mg</title>
          <description>Simvastatin 40 mg: simvastatin, generic tablet over-encapsulated, 40 mg, once daily, 12 weeks</description>
        </group>
        <group group_id="P5">
          <title>Fenofibrate 145 mg</title>
          <description>Fenofibrate 145 mg: Fenofibrate, tablet, 145 mg, once daily, 12 weeks</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="114"/>
                <participants group_id="P2" count="117"/>
                <participants group_id="P3" count="115"/>
                <participants group_id="P4" count="116"/>
                <participants group_id="P5" count="113"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>Full Analysis Subject Sample</title>
              <participants_list>
                <participants group_id="P1" count="109"/>
                <participants group_id="P2" count="114"/>
                <participants group_id="P3" count="110"/>
                <participants group_id="P4" count="112"/>
                <participants group_id="P5" count="111"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>Safety Subject Sample</title>
              <participants_list>
                <participants group_id="P1" count="111"/>
                <participants group_id="P2" count="117"/>
                <participants group_id="P3" count="113"/>
                <participants group_id="P4" count="115"/>
                <participants group_id="P5" count="112"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="104"/>
                <participants group_id="P2" count="108"/>
                <participants group_id="P3" count="106"/>
                <participants group_id="P4" count="108"/>
                <participants group_id="P5" count="102"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="10"/>
                <participants group_id="P2" count="9"/>
                <participants group_id="P3" count="9"/>
                <participants group_id="P4" count="8"/>
                <participants group_id="P5" count="11"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Adverse Event</title>
              <participants_list>
                <participants group_id="P1" count="5"/>
                <participants group_id="P2" count="6"/>
                <participants group_id="P3" count="3"/>
                <participants group_id="P4" count="4"/>
                <participants group_id="P5" count="6"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Protocol Violation</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
                <participants group_id="P2" count="2"/>
                <participants group_id="P3" count="5"/>
                <participants group_id="P4" count="4"/>
                <participants group_id="P5" count="3"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Administrative</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 group_id="P5" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Lack of Efficacy</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="1"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>Full analysis subject sample</population>
      <group_list>
        <group group_id="B1">
          <title>Fenofibrate/Simvastatin 145/20 mg</title>
          <description>Fenofibrate/simvastatin 145/20 mg: Fenofibrate/simvastatin oval biconvex film-coated tablet, 145 mg / 20 mg, once daily, 12 weeks</description>
        </group>
        <group group_id="B2">
          <title>Simvastatin 20 mg</title>
          <description>Simvastatin 20 mg: Simvastatin generic tablet over-encapsulated, 20 mg, once daily, 12 weeks</description>
        </group>
        <group group_id="B3">
          <title>Fenofibrate/Simvastatin 145/40 mg</title>
          <description>Fenofibrate/simvastatin 145/40 mg: Fenofibrate/simvastatin film-coated tablet 145 mg / 40 mg, once daily, 12 weeks</description>
        </group>
        <group group_id="B4">
          <title>Simvastatin 40 mg</title>
          <description>Simvastatin 40 mg: simvastatin, generic tablet over-encapsulated, 40 mg, once daily, 12 weeks</description>
        </group>
        <group group_id="B5">
          <title>Fenofibrate 145 mg</title>
          <description>Fenofibrate 145 mg: Fenofibrate, tablet, 145 mg, once daily, 12 weeks</description>
        </group>
        <group group_id="B6">
          <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="109"/>
            <count group_id="B2" value="114"/>
            <count group_id="B3" value="110"/>
            <count group_id="B4" value="112"/>
            <count group_id="B5" value="111"/>
            <count group_id="B6" value="556"/>
          </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="59.6" spread="10"/>
                    <measurement group_id="B2" value="60.5" spread="9.3"/>
                    <measurement group_id="B3" value="60.4" spread="8.1"/>
                    <measurement group_id="B4" value="59.3" spread="9.1"/>
                    <measurement group_id="B5" value="60.4" spread="9.0"/>
                    <measurement group_id="B6" value="60.0" spread="9.1"/>
                  </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="38"/>
                    <measurement group_id="B2" value="40"/>
                    <measurement group_id="B3" value="43"/>
                    <measurement group_id="B4" value="39"/>
                    <measurement group_id="B5" value="38"/>
                    <measurement group_id="B6" value="198"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="71"/>
                    <measurement group_id="B2" value="74"/>
                    <measurement group_id="B3" value="67"/>
                    <measurement group_id="B4" value="73"/>
                    <measurement group_id="B5" value="73"/>
                    <measurement group_id="B6" value="358"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>Czech Republic</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="22"/>
                    <measurement group_id="B2" value="22"/>
                    <measurement group_id="B3" value="22"/>
                    <measurement group_id="B4" value="23"/>
                    <measurement group_id="B5" value="21"/>
                    <measurement group_id="B6" value="110"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Mexico</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="7"/>
                    <measurement group_id="B2" value="9"/>
                    <measurement group_id="B3" value="8"/>
                    <measurement group_id="B4" value="7"/>
                    <measurement group_id="B5" value="8"/>
                    <measurement group_id="B6" value="39"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Argentina</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="19"/>
                    <measurement group_id="B2" value="22"/>
                    <measurement group_id="B3" value="19"/>
                    <measurement group_id="B4" value="20"/>
                    <measurement group_id="B5" value="21"/>
                    <measurement group_id="B6" value="101"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Poland</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="7"/>
                    <measurement group_id="B2" value="9"/>
                    <measurement group_id="B3" value="8"/>
                    <measurement group_id="B4" value="10"/>
                    <measurement group_id="B5" value="7"/>
                    <measurement group_id="B6" value="41"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Romania</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="6"/>
                    <measurement group_id="B2" value="6"/>
                    <measurement group_id="B3" value="6"/>
                    <measurement group_id="B4" value="5"/>
                    <measurement group_id="B5" value="4"/>
                    <measurement group_id="B6" value="27"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Russian Federation</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="18"/>
                    <measurement group_id="B2" value="17"/>
                    <measurement group_id="B3" value="16"/>
                    <measurement group_id="B4" value="16"/>
                    <measurement group_id="B5" value="17"/>
                    <measurement group_id="B6" value="84"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Germany</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="30"/>
                    <measurement group_id="B2" value="29"/>
                    <measurement group_id="B3" value="31"/>
                    <measurement group_id="B4" value="31"/>
                    <measurement group_id="B5" value="33"/>
                    <measurement group_id="B6" value="154"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Triglycerides (mmol/L)</title>
          <units>mmol/L</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="2.8" spread="1.1"/>
                    <measurement group_id="B2" value="2.5" spread="1.0"/>
                    <measurement group_id="B3" value="2.7" spread="1.4"/>
                    <measurement group_id="B4" value="2.7" spread="1.0"/>
                    <measurement group_id="B5" value="2.9" spread="1.3"/>
                    <measurement group_id="B6" value="2.7" spread="1.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>LDL Cholesterol (mmol/L)</title>
          <units>mmol/L</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="2.6" spread="0.5"/>
                    <measurement group_id="B2" value="2.6" spread="0.4"/>
                    <measurement group_id="B3" value="2.6" spread="0.4"/>
                    <measurement group_id="B4" value="2.7" spread="0.4"/>
                    <measurement group_id="B5" value="2.7" spread="0.5"/>
                    <measurement group_id="B6" value="2.7" spread="0.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>HDL Cholesterol (mmol/L)</title>
          <units>mmol/L</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="1.1" spread="0.3"/>
                    <measurement group_id="B2" value="1.2" spread="0.3"/>
                    <measurement group_id="B3" value="1.2" spread="0.3"/>
                    <measurement group_id="B4" value="1.2" spread="0.3"/>
                    <measurement group_id="B5" value="1.2" spread="0.3"/>
                    <measurement group_id="B6" value="1.2" spread="0.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Percentage of Change of TG (Triglyceride)</title>
        <description>Collection and measurement of blood samples.</description>
        <time_frame>from baseline to 12 weeks of treatment</time_frame>
        <population>The Primary Analysis was done for the sample set of patients with 12 weeks' assessment.</population>
        <group_list>
          <group group_id="O1">
            <title>Fenofibrate/Simvastatin 145/20 mg</title>
            <description>Fenofibrate/simvastatin 145/20 mg: Fenofibrate/simvastatin oval biconvex film-coated tablet, 145 mg / 20 mg, once daily, 12 weeks</description>
          </group>
          <group group_id="O2">
            <title>Simvastatin 20 mg</title>
            <description>Simvastatin 20 mg: Simvastatin generic tablet over-encapsulated, 20 mg, once daily, 12 weeks</description>
          </group>
          <group group_id="O3">
            <title>Fenofibrate/Simvastatin 145/40 mg</title>
            <description>Fenofibrate/simvastatin 145/40 mg: Fenofibrate/simvastatin film-coated tablet 145 mg / 40 mg, once daily, 12 weeks</description>
          </group>
          <group group_id="O4">
            <title>Simvastatin 40 mg</title>
            <description>Simvastatin 40 mg: simvastatin, generic tablet over-encapsulated, 40 mg, once daily, 12 weeks</description>
          </group>
          <group group_id="O5">
            <title>Fenofibrate 145 mg</title>
            <description>Fenofibrate 145 mg: Fenofibrate, tablet, 145 mg, once daily, 12 weeks</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Change of TG (Triglyceride)</title>
          <description>Collection and measurement of blood samples.</description>
          <population>The Primary Analysis was done for the sample set of patients with 12 weeks' assessment.</population>
          <units>percentage of change</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="96"/>
                <count group_id="O2" value="102"/>
                <count group_id="O3" value="97"/>
                <count group_id="O4" value="101"/>
                <count group_id="O5" value="93"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-30.6" spread="25.8"/>
                    <measurement group_id="O2" value="10.7" spread="48.8"/>
                    <measurement group_id="O3" value="-27.3" spread="35.9"/>
                    <measurement group_id="O4" value="-2.9" spread="34.3"/>
                    <measurement group_id="O5" value="-21.6" spread="34.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Percentage of Change of HDL-C (High Density Lipoprotein Cholesterol)</title>
        <description>Collection and measurement of blood samples.</description>
        <time_frame>from baseline to 12 weeks of treatment</time_frame>
        <population>The Primary Analysis was done for the sample set of patients with 12 weeks' assessment.</population>
        <group_list>
          <group group_id="O1">
            <title>Fenofibrate/Simvastatin 145/20 mg</title>
            <description>Fenofibrate/simvastatin 145/20 mg: Fenofibrate/simvastatin oval biconvex film-coated tablet, 145 mg / 20 mg, once daily, 12 weeks</description>
          </group>
          <group group_id="O2">
            <title>Simvastatin 20 mg</title>
            <description>Simvastatin 20 mg: Simvastatin generic tablet over-encapsulated, 20 mg, once daily, 12 weeks</description>
          </group>
          <group group_id="O3">
            <title>Fenofibrate/Simvastatin 145/40 mg</title>
            <description>Fenofibrate/simvastatin 145/40 mg: Fenofibrate/simvastatin film-coated tablet 145 mg / 40 mg, once daily, 12 weeks</description>
          </group>
          <group group_id="O4">
            <title>Simvastatin 40 mg</title>
            <description>Simvastatin 40 mg: simvastatin, generic tablet over-encapsulated, 40 mg, once daily, 12 weeks</description>
          </group>
          <group group_id="O5">
            <title>Fenofibrate 145 mg</title>
            <description>Fenofibrate 145 mg: Fenofibrate, tablet, 145 mg, once daily, 12 weeks</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Change of HDL-C (High Density Lipoprotein Cholesterol)</title>
          <description>Collection and measurement of blood samples.</description>
          <population>The Primary Analysis was done for the sample set of patients with 12 weeks' assessment.</population>
          <units>percentage of change</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="96"/>
                <count group_id="O2" value="102"/>
                <count group_id="O3" value="97"/>
                <count group_id="O4" value="101"/>
                <count group_id="O5" value="93"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="9.0" spread="16.8"/>
                    <measurement group_id="O2" value="0.3" spread="12.1"/>
                    <measurement group_id="O3" value="8.8" spread="16.5"/>
                    <measurement group_id="O4" value="2.2" spread="12.5"/>
                    <measurement group_id="O5" value="7.6" spread="15.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Percentage of Change of LDL-C (Low Density Lipoprotein Cholesterol)</title>
        <description>Collection and measurement of blood samples.</description>
        <time_frame>from baseline to 12 weeks of treatment</time_frame>
        <population>The Primary Analysis was done for the sample set of patients with 12 weeks' assessment.</population>
        <group_list>
          <group group_id="O1">
            <title>Fenofibrate/Simvastatin 145/20 mg</title>
            <description>Fenofibrate/simvastatin 145/20 mg: Fenofibrate/simvastatin oval biconvex film-coated tablet, 145 mg / 20 mg, once daily, 12 weeks</description>
          </group>
          <group group_id="O2">
            <title>Simvastatin 20 mg</title>
            <description>Simvastatin 20 mg: Simvastatin generic tablet over-encapsulated, 20 mg, once daily, 12 weeks</description>
          </group>
          <group group_id="O3">
            <title>Fenofibrate/Simvastatin 145/40 mg</title>
            <description>Fenofibrate/simvastatin 145/40 mg: Fenofibrate/simvastatin film-coated tablet 145 mg / 40 mg, once daily, 12 weeks</description>
          </group>
          <group group_id="O4">
            <title>Simvastatin 40 mg</title>
            <description>Simvastatin 40 mg: simvastatin, generic tablet over-encapsulated, 40 mg, once daily, 12 weeks</description>
          </group>
          <group group_id="O5">
            <title>Fenofibrate 145 mg</title>
            <description>Fenofibrate 145 mg: Fenofibrate, tablet, 145 mg, once daily, 12 weeks</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Change of LDL-C (Low Density Lipoprotein Cholesterol)</title>
          <description>Collection and measurement of blood samples.</description>
          <population>The Primary Analysis was done for the sample set of patients with 12 weeks' assessment.</population>
          <units>percentage of change</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="96"/>
                <count group_id="O2" value="102"/>
                <count group_id="O3" value="97"/>
                <count group_id="O4" value="101"/>
                <count group_id="O5" value="93"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.9" spread="25.4"/>
                    <measurement group_id="O2" value="-2.0" spread="24.8"/>
                    <measurement group_id="O3" value="-6.1" spread="26.2"/>
                    <measurement group_id="O4" value="-8.1" spread="25.8"/>
                    <measurement group_id="O5" value="30.3" spread="35.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Non-HDL (High Density Lipoprotein)-C From Baseline</title>
        <description>Collection and measurement of blood samples</description>
        <time_frame>12 weeks</time_frame>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of TC (Triglyceride) From Baseline</title>
        <description>Collection and measurement of blood samples</description>
        <time_frame>12 weeks</time_frame>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Apolipoprotein AI From Baseline</title>
        <description>Collection and measurement of blood samples</description>
        <time_frame>12 weeks</time_frame>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Apolipoprotein B From Baseline</title>
        <description>Collection and measurement of blood samples</description>
        <time_frame>12 weeks</time_frame>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of High-sensitivity C-reactive Protein (hsCRP) From Baseline</title>
        <description>Collection and measurement of blood samples</description>
        <time_frame>12 weeks</time_frame>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Subjects Meeting Target Levels of Lipids (According to Very High or High Risk)</title>
        <description>Collection and measurement of blood samples</description>
        <time_frame>12 weeks</time_frame>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Adverse Events</title>
        <description>Collection and measurement of blood samples</description>
        <time_frame>12 weeks</time_frame>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Creatine Kinase (CK)</title>
        <description>Collection and measurement of blood samples</description>
        <time_frame>12 weeks</time_frame>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Alanine Aminotransferase (ALT)</title>
        <description>Collection and measurement of blood samples</description>
        <time_frame>12 weeks</time_frame>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Plasma Creatinine</title>
        <description>Collection and measurement of blood samples</description>
        <time_frame>12 weeks</time_frame>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Total Bilirubin</title>
        <description>Collection and measurement of blood samples</description>
        <time_frame>12 weeks</time_frame>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Cystatin C</title>
        <description>Collection and measurement of blood samples</description>
        <time_frame>12 weeks</time_frame>
      </outcome>
    </outcome_list>

    <reported_events>
      <group_list>
        <group group_id="E1">
          <title>Fenofibrate/Simvastatin 145/20 mg</title>
          <description>Fenofibrate/simvastatin 145/20 mg: Fenofibrate/simvastatin oval biconvex film-coated tablet, 145 mg / 20 mg, once daily, 12 weeks</description>
        </group>
        <group group_id="E2">
          <title>Simvastatin 20 mg</title>
          <description>Simvastatin 20 mg: Simvastatin generic tablet over-encapsulated, 20 mg, once daily, 12 weeks</description>
        </group>
        <group group_id="E3">
          <title>Fenofibrate/Simvastatin 145/40 mg</title>
          <description>Fenofibrate/simvastatin 145/40 mg: Fenofibrate/simvastatin film-coated tablet 145 mg / 40 mg, once daily, 12 weeks</description>
        </group>
        <group group_id="E4">
          <title>Simvastatin 40 mg</title>
          <description>Simvastatin 40 mg: simvastatin, generic tablet over-encapsulated, 40 mg, once daily, 12 weeks</description>
        </group>
        <group group_id="E5">
          <title>Fenofibrate 145 mg</title>
          <description>Fenofibrate 145 mg: Fenofibrate, tablet, 145 mg, once daily, 12 weeks</description>
        </group>
      </group_list>
      <serious_events>
        <default_vocab>MedDra</default_vocab>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="111"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="117"/>
                <counts group_id="E3" subjects_affected="3" subjects_at_risk="113"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="115"/>
                <counts group_id="E5" subjects_affected="3" subjects_at_risk="112"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>ACUTE CORONARY SYNDROME</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="111"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="117"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="113"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="115"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="112"/>
              </event>
              <event>
                <sub_title>ACUTE MYOCARDIAL INFARCTION</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="111"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="117"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="113"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="115"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="112"/>
              </event>
              <event>
                <sub_title>ANGINA PECTORIS</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="111"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="117"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="113"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="115"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="112"/>
              </event>
              <event>
                <sub_title>MYOCARDIAL INFARCTION</sub_title>
                <description>One Myocardial Infarction was fatal.</description>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="111"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="117"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="113"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="115"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="112"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Ear and labyrinth disorders</title>
            <event_list>
              <event>
                <sub_title>VESTIBULAR DISORDER</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="111"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="117"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="113"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="115"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="112"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>INTESTINAL HAEMORRHAGE</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="111"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="117"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="113"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="115"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="112"/>
              </event>
              <event>
                <sub_title>UMBILICAL HERNIA, OBSTRUCTIVE</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="111"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="117"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="113"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="115"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="112"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>NON-SITE SPECIFIC INJURIES NEC</sub_title>
                <description>One Injury was fatal.</description>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="111"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="117"/>
                <counts group_id="E3" events="2" subjects_affected="1" subjects_at_risk="113"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="115"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="112"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title>DIABETES MELLITUS</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="111"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="117"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="113"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="115"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="112"/>
              </event>
              <event>
                <sub_title>DIABETES MELLITUS INADEQUATE CONTROL</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="111"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="117"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="113"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="115"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="112"/>
              </event>
              <event>
                <sub_title>TYPE 2 DIABETES MELLITUS</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="111"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="117"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="113"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="115"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="112"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>BURSITIS</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="111"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="117"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="113"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="115"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="112"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>CEREBROVASCULAR ACCIDENT</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="111"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="117"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="113"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="115"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="112"/>
              </event>
              <event>
                <sub_title>LOSS OF CONSCIOUSNESS</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="111"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="117"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="113"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="115"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="112"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Renal and urinary disorders</title>
            <event_list>
              <event>
                <sub_title>HAEMATURIA</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="111"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="117"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="113"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="115"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="112"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Surgical and medical procedures</title>
            <event_list>
              <event>
                <sub_title>DIABETES MELLITUS MANAGEMENT</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="111"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="117"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="113"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="115"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="112"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>2</frequency_threshold>
        <default_vocab>MedDRA (15.1)</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="8" subjects_at_risk="111"/>
                <counts group_id="E2" subjects_affected="7" subjects_at_risk="117"/>
                <counts group_id="E3" subjects_affected="4" subjects_at_risk="113"/>
                <counts group_id="E4" subjects_affected="9" subjects_at_risk="115"/>
                <counts group_id="E5" subjects_affected="15" subjects_at_risk="112"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>DIARRHOEA</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="111"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="117"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="113"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="115"/>
                <counts group_id="E5" subjects_affected="5" subjects_at_risk="112"/>
              </event>
              <event>
                <sub_title>DYSPEPSIA</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="111"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="117"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="113"/>
                <counts group_id="E4" subjects_affected="4" subjects_at_risk="115"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="112"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>NASOPHARYNGITIS</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="111"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="117"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="113"/>
                <counts group_id="E4" subjects_affected="3" subjects_at_risk="115"/>
                <counts group_id="E5" subjects_affected="3" subjects_at_risk="112"/>
              </event>
              <event>
                <sub_title>GASTROENTERITIS</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="111"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="117"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="113"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="115"/>
                <counts group_id="E5" subjects_affected="4" subjects_at_risk="112"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>BLOOD CREATINE PHOSPHOKINASE INCREASED</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="111"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="117"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="113"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="115"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="112"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>COUGH</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="111"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="117"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="113"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="115"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="112"/>
              </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>At least sixty (60) days prior to submitting or presenting a manuscript or other materials relating to the Study to a publisher, reviewer, or other outside persons, the PI shall provide to Sponsor a copy of all such manuscripts and materials, and allow Sponsor sixty (60) days to review and comment on them. If the Sponsor requests, the PI shall remove any Confidential Information (other than Study results) prior to submitting or presenting the materials.</restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Associate Director Clinical Services</name_or_title>
      <organization>Abbott</organization>
      <email>taco.baardman@abbott.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/NCT01674712
org study id: M13-377
secondary id: 2011-005924-16
nct id: NCT01674712
lead sponsor: 
This is a double-blind, randomized study designed to compare the efficacy and safety of two
      fixed combinations of fenofibrate / simvastatin 145/20 mg and fenofibrate / simvastatin
      145/40 mg tablets vs. matching monotherapies in subjects with abnormal fat (lipids) in the
      blood and at high risk of cardiovascular disease. Fenofibrate is a treatment that lowers fat
      in blood. It is prescribed in patients with high levels of triglycerides (TG). The drug has
      been marketed in more than 80 countries since 1975. Simvastatin is also used for the
      treatment of patients with a high level of cholesterol. These have also been marketed
      worldwide for more than 20 years. It is important to treat high levels of fats in the blood
      because it has been shown that even mildly elevated level of lipids in the blood can lead to
      diseases of the blood vessels. It has been shown in several studies and in clinical practice
      that the combination of fenofibrate plus simvastatin can lead to improved effects on blood
      fats, compared to treatment with simvastatin or fenofibrate alone. The main objective of the
      study is to compare the efficacy of the two fixed-combinations (FC) -fenofibrate/simvastatin
      145/20 mg tablet and fenofibrate/simvastatin 145/40 mg tablet in reducing TG and increasing
      high density lipoprotein cholesterol (HDL-C) versus simvastatin 20 mg or 40 mg, and in
      reducing low density lipoprotein cholesterol (LDL-C) versus fenofibrate 145 mg.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Percentage of Change of TG (Triglyceride)
time frame: from baseline to 12 weeks of treatment
description: Collection and measurement of blood samples.
measure: Percentage of Change of HDL-C (High Density Lipoprotein Cholesterol)
time frame: from baseline to 12 weeks of treatment
description: Collection and measurement of blood samples.
measure: Percentage of Change of LDL-C (Low Density Lipoprotein Cholesterol)
time frame: from baseline to 12 weeks of treatment
description: Collection and measurement of blood samples.
measure: Percentage of Non-HDL (High Density Lipoprotein)-C From Baseline
time frame: 12 weeks
description: Collection and measurement of blood samples
measure: Percentage of TC (Triglyceride) From Baseline
time frame: 12 weeks
description: Collection and measurement of blood samples
measure: Percentage of Apolipoprotein AI From Baseline
time frame: 12 weeks
description: Collection and measurement of blood samples
measure: Percentage of Apolipoprotein B From Baseline
time frame: 12 weeks
description: Collection and measurement of blood samples
measure: Percentage of High-sensitivity C-reactive Protein (hsCRP) From Baseline
time frame: 12 weeks
description: Collection and measurement of blood samples
measure: Percentage of Subjects Meeting Target Levels of Lipids (According to Very High or High Risk)
time frame: 12 weeks
description: Collection and measurement of blood samples
measure: Adverse Events
time frame: 12 weeks
description: Collection and measurement of blood samples
measure: Creatine Kinase (CK)
time frame: 12 weeks
description: Collection and measurement of blood samples
measure: Alanine Aminotransferase (ALT)
time frame: 12 weeks
description: Collection and measurement of blood samples
measure: Plasma Creatinine
time frame: 12 weeks
description: Collection and measurement of blood samples
measure: Total Bilirubin
time frame: 12 weeks
description: Collection and measurement of blood samples
measure: Cystatin C
time frame: 12 weeks
description: Collection and measurement of blood samples
arm group label: Fenofibrate/simvastatin 145/20 mg
arm group type: Experimental
arm group label: Simvastatin 20 mg
arm group type: Active Comparator
arm group label: Fenofibrate 145 mg
arm group type: Active Comparator
arm group label: Fenofibrate/simvastatin 145/40 mg
arm group type: Experimental
arm group label: Simvastatin 40 mg
arm group type: Active Comparator
intervention type: Drug
intervention name: Fixed Combination of Fenofibrate/simvastatin 145/20 mg
description: Fenofibrate/simvastatin oval biconvex film-coated tablet, 145 mg / 20 mg, once daily, 12 weeks
arm group label: Fenofibrate/simvastatin 145/20 mg
intervention type: Drug
intervention name: Simvastatin 20 mg
description: Simvastatin generic tablet over-encapsulated, 20 mg, once daily, 12 weeks
arm group label: Simvastatin 20 mg
intervention type: Drug
intervention name: Fenofibrate 145 mg
description: Fenofibrate, tablet, 145 mg, once daily, 12 weeks
arm group label: Fenofibrate 145 mg
intervention type: Drug
intervention name: Fixed Combination of Fenofibrate/simvastatin 145/40 mg
description: Fenofibrate/simvastatin film-coated tablet 145 mg / 40 mg, once daily, 12 weeks
arm group label: Fenofibrate/simvastatin 145/40 mg
intervention type: Drug
intervention name: Simvastatin 40 mg
description: simvastatin, generic tablet over-encapsulated, 40 mg, once daily, 12 weeks
arm group label: Simvastatin 40 mg
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: No
last name: Jean-Claude Ansquer, MD
role: Study Director
affiliation: Abbott
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country: Argentina
country: Czech Republic
country: Germany
country: Mexico
country: Poland
country: Romania
country: Russian Federation
responsible party type: Sponsor
mesh term: Cardiovascular Diseases
mesh term: Dyslipidemias
mesh term: Simvastatin
mesh term: Fenofibrate
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point of contact: 