<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/NCT01717300</url>
  </required_header>
  <id_info>
    <org_study_id>0859-021</org_study_id>
    <secondary_id>2012-003110-14</secondary_id>
    <nct_id>NCT01717300</nct_id>
  </id_info>
  <brief_title>A Study of the Safety and Efficacy of Anacetrapib (MK-0859) When Added to Ongoing Statin Therapy (MK-0859-021)</brief_title>
  <official_title>A 24-Week, Worldwide, Multicenter, Double-Blind, Randomized, Parallel, Placebo-Controlled Study to Assess the Efficacy and Tolerability of Anacetrapib When Added to Ongoing Statin Therapy With or Without Other Lipid Modifying Medication(s) in Patients With Hypercholesterolemia or Low HDL-C</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Merck Sharp &amp; Dohme LLC</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Merck Sharp &amp; Dohme LLC</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study will evaluate the effects of 2 different dose levels of anacetrapib on low-density&#xD;
      lipoprotein-cholesterol (LDL-C) and high-density lipoprotein cholesterol (HDL-C) in&#xD;
      participants with hypercholesterolemia when added to an existing statin-modifying therapy.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">November 6, 2012</start_date>
  <completion_date type="Actual">October 29, 2014</completion_date>
  <primary_completion_date type="Actual">October 29, 2014</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>Percent Change from Baseline in LDL-C (beta-quantification [BQ] method)</measure>
    <time_frame>Baseline and Week 24</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Percent Change from Baseline in HDL-C</measure>
    <time_frame>Baseline and Week 24</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of Participants with Alanine Transaminase (ALT) or Aspartate Aminotransferase (AST) Consecutive Elevations ≥3xULN (Upper Limit of Normal)</measure>
    <time_frame>24 Weeks</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of Participants with Creatine Phosphokinase Elevations ≥10xULN with or without Muscle Symptoms</measure>
    <time_frame>24 weeks</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of Participants with Sodium, Chloride, or Bicarbonate Elevations &gt;ULN or Potassium Levels &lt;LLN (Lower Limit of Normal)</measure>
    <time_frame>24 weeks</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of Participants with Pre-specified Adjudicated Cardiovascular Serious Adverse Events or Death from Any Cause</measure>
    <time_frame>24 weeks</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of Participants with Significant Increase in Blood Pressure</measure>
    <time_frame>24 weeks</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Percent change from Baseline in non-HDL-C</measure>
    <time_frame>Baseline and Week 24</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percent Change from Baseline in Apolipoprotein B (Apo-B)</measure>
    <time_frame>Baseline and Week 24</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percent Change from Baseline in Apolipoprotein A-I (Apo-A-I)</measure>
    <time_frame>Baseline and Week 24</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percent Change from Baseline in Lipoprotein(a) (lp[a])</measure>
    <time_frame>Baseline and Week 24</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percent Change from Baseline in HDL-C Among Participants with Low HDL-C at LDL-C goal</measure>
    <time_frame>Baseline and Week 24</time_frame>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">459</enrollment>
  <condition>Hypercholesterolemia</condition>
  <arm_group>
    <arm_group_label>Anacetrapib 100 mg</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Anacetrapib 25 mg</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>Anacetrapib 100 mg</intervention_name>
    <description>100 mg tablet, oral, once daily for 24 weeks</description>
    <arm_group_label>Anacetrapib 100 mg</arm_group_label>
    <other_name>MK-0859</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo for anacetrapib 100 mg</intervention_name>
    <description>Placebo tablet, orally, once daily for 24 weeks</description>
    <arm_group_label>Anacetrapib 25 mg</arm_group_label>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Anacetrapib 25 mg</intervention_name>
    <description>25 mg tablet, oral, once daily for 24 weeks</description>
    <arm_group_label>Anacetrapib 25 mg</arm_group_label>
    <other_name>MK-0859</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo for anacetrapib 25 mg</intervention_name>
    <description>Placebo tablet, orally, once daily for 24 weeks</description>
    <arm_group_label>Anacetrapib 100 mg</arm_group_label>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  If female, cannot be of reproductive potential&#xD;
&#xD;
          -  Have been treated with an optimal dose of statin for at least 6 weeks&#xD;
&#xD;
          -  Coronary heart disease (CHD) or other atherosclerotic vascular disease with multiple&#xD;
             risk factors (including diabetes, metabolic syndrome) and/or high LDL-C/low HDL-C, or&#xD;
             needing to meet a specific LDL-C/HDL-C goal&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Previously participated in a study with a cholesteryl ester transfer protein (CETP)&#xD;
             inhibitor&#xD;
&#xD;
          -  Homozygous familial hypercholesterolemia&#xD;
&#xD;
          -  Severe chronic heart failure&#xD;
&#xD;
          -  Uncontrolled cardiac arrhythmias, myocardial infarction (MI), percutaneous coronary&#xD;
             intervention (PCI), coronary artery by-pass graft (CABG), unstable angina, or stroke&#xD;
             within 3 months&#xD;
&#xD;
          -  Uncontrolled hypertension&#xD;
&#xD;
          -  Uncontrolled endocrine or metabolic disease known to influence serum lipids or&#xD;
             lipoproteins&#xD;
&#xD;
          -  Active or chronic hepatobiliary, hepatic, or gall bladder disease&#xD;
&#xD;
          -  History of mental instability, drug/alcohol abuse within the past five years or major&#xD;
             psychiatric illness inadequately controlled and unstable&#xD;
&#xD;
          -  History of ileal bypass, gastric bypass, or other significant condition associated&#xD;
             with malabsorption&#xD;
&#xD;
          -  Human immunodeficiency virus (HIV) positive&#xD;
&#xD;
          -  History of malignancy ≤5 years&#xD;
&#xD;
          -  Donated blood products or has had phlebotomy of &gt;300 mL within 8 weeks or intends to&#xD;
             donate 250 mL of blood products or receive blood products within the projected&#xD;
             duration of the study&#xD;
&#xD;
          -  Currently taking medications that are potent inhibitors or inducers of cytochrome P450&#xD;
             3A4 (CYP3A) (including but not limited to cyclosporine, systemic itraconazole or&#xD;
             ketoconazole, erythromycin, clarithromycin, or telithromycin, nefazodone, protease&#xD;
             inhibitors, carbamazepine, phenobarbital, phenytoin, rifabutin, rifampin, St John's&#xD;
             wort) or has discontinued treatment &lt;3 weeks prior&#xD;
&#xD;
          -  Consumes more than 2 alcoholic drinks per day&#xD;
&#xD;
          -  Currently participating or has participated in a study with an investigational&#xD;
             compound or device within 3 months&#xD;
&#xD;
          -  Receiving treatment with systemic corticosteroids or taking systemic anabolic agents&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <removed_countries>
    <country>Bulgaria</country>
    <country>Canada</country>
    <country>Germany</country>
    <country>Hungary</country>
    <country>Israel</country>
    <country>Netherlands</country>
    <country>Poland</country>
    <country>Puerto Rico</country>
    <country>Romania</country>
    <country>Slovakia</country>
    <country>Spain</country>
    <country>United Kingdom</country>
    <country>United States</country>
  </removed_countries>
  <results_reference>
    <citation>Ballantyne CM, Shah S, Kher U, Hunter JA, Gill GG, Cressman MD, Ashraf TB, Johnson-Levonas AO, Mitchel YB. Lipid-Modifying Efficacy and Tolerability of Anacetrapib Added to Ongoing Statin Therapy in Patients with Hypercholesterolemia or Low High-Density Lipoprotein Cholesterol. Am J Cardiol. 2017 Feb 1;119(3):388-396. doi: 10.1016/j.amjcard.2016.10.032. Epub 2016 Nov 1.</citation>
    <PMID>27956003</PMID>
  </results_reference>
  <verification_date>April 2017</verification_date>
  <study_first_submitted>October 26, 2012</study_first_submitted>
  <study_first_submitted_qc>October 26, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 30, 2012</study_first_posted>
  <last_update_submitted>April 13, 2017</last_update_submitted>
  <last_update_submitted_qc>April 13, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">April 17, 2017</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>Hypercholesterolemia</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Oxazolidinones</mesh_term>
    <mesh_term>Anacetrapib</mesh_term>
  </intervention_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT01717300
org study id: 0859-021
secondary id: 2012-003110-14
nct id: NCT01717300
lead sponsor: 
has dmc: No
This study will evaluate the effects of 2 different dose levels of anacetrapib on low-density
      lipoprotein-cholesterol (LDL-C) and high-density lipoprotein cholesterol (HDL-C) in
      participants with hypercholesterolemia when added to an existing statin-modifying therapy.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Investigator)
measure: Percent Change from Baseline in LDL-C (beta-quantification [BQ] method)
time frame: Baseline and Week 24
measure: Percent Change from Baseline in HDL-C
time frame: Baseline and Week 24
measure: Number of Participants with Alanine Transaminase (ALT) or Aspartate Aminotransferase (AST) Consecutive Elevations ≥3xULN (Upper Limit of Normal)
time frame: 24 Weeks
measure: Number of Participants with Creatine Phosphokinase Elevations ≥10xULN with or without Muscle Symptoms
time frame: 24 weeks
measure: Number of Participants with Sodium, Chloride, or Bicarbonate Elevations >ULN or Potassium Levels <LLN (Lower Limit of Normal)
time frame: 24 weeks
measure: Number of Participants with Pre-specified Adjudicated Cardiovascular Serious Adverse Events or Death from Any Cause
time frame: 24 weeks
measure: Number of Participants with Significant Increase in Blood Pressure
time frame: 24 weeks
measure: Percent change from Baseline in non-HDL-C
time frame: Baseline and Week 24
measure: Percent Change from Baseline in Apolipoprotein B (Apo-B)
time frame: Baseline and Week 24
measure: Percent Change from Baseline in Apolipoprotein A-I (Apo-A-I)
time frame: Baseline and Week 24
measure: Percent Change from Baseline in Lipoprotein(a) (lp[a])
time frame: Baseline and Week 24
measure: Percent Change from Baseline in HDL-C Among Participants with Low HDL-C at LDL-C goal
time frame: Baseline and Week 24
arm group label: Anacetrapib 100 mg
arm group type: Experimental
arm group label: Anacetrapib 25 mg
arm group type: Experimental
arm group label: Placebo
arm group type: Placebo Comparator
intervention type: Drug
intervention name: Anacetrapib 100 mg
description: 100 mg tablet, oral, once daily for 24 weeks
arm group label: Anacetrapib 100 mg
other name: MK-0859
intervention type: Drug
intervention name: Placebo for anacetrapib 100 mg
description: Placebo tablet, orally, once daily for 24 weeks
arm group label: Anacetrapib 25 mg
arm group label: Placebo
intervention type: Drug
intervention name: Anacetrapib 25 mg
description: 25 mg tablet, oral, once daily for 24 weeks
arm group label: Anacetrapib 25 mg
other name: MK-0859
intervention type: Drug
intervention name: Placebo for anacetrapib 25 mg
description: Placebo tablet, orally, once daily for 24 weeks
arm group label: Anacetrapib 100 mg
arm group label: Placebo
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: No
country: Bulgaria
country: Canada
country: Germany
country: Hungary
country: Israel
country: Netherlands
country: Poland
country: Puerto Rico
country: Romania
country: Slovakia
country: Spain
country: United Kingdom
country: United States
citation: Ballantyne CM, Shah S, Kher U, Hunter JA, Gill GG, Cressman MD, Ashraf TB, Johnson-Levonas AO, Mitchel YB. Lipid-Modifying Efficacy and Tolerability of Anacetrapib Added to Ongoing Statin Therapy in Patients with Hypercholesterolemia or Low High-Density Lipoprotein Cholesterol. Am J Cardiol. 2017 Feb 1;119(3):388-396. doi: 10.1016/j.amjcard.2016.10.032. Epub 2016 Nov 1.
PMID: 27956003
responsible party type: Sponsor
mesh term: Hypercholesterolemia
mesh term: Oxazolidinones
mesh term: Anacetrapib