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A Study of the Safety and Efficacy of Anacetrapib (MK-0859) When Added to Ongoing Statin Therapy (MK-0859-021)

Primary Purpose

Hypercholesterolemia

Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Anacetrapib 100 mg
Placebo for anacetrapib 100 mg
Anacetrapib 25 mg
Placebo for anacetrapib 25 mg
Sponsored by
Merck Sharp & Dohme LLC
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hypercholesterolemia

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • If female, cannot be of reproductive potential
  • Have been treated with an optimal dose of statin for at least 6 weeks
  • Coronary heart disease (CHD) or other atherosclerotic vascular disease with multiple risk factors (including diabetes, metabolic syndrome) and/or high LDL-C/low HDL-C, or needing to meet a specific LDL-C/HDL-C goal

Exclusion Criteria:

  • Previously participated in a study with a cholesteryl ester transfer protein (CETP) inhibitor
  • Homozygous familial hypercholesterolemia
  • Severe chronic heart failure
  • Uncontrolled cardiac arrhythmias, myocardial infarction (MI), percutaneous coronary intervention (PCI), coronary artery by-pass graft (CABG), unstable angina, or stroke within 3 months
  • Uncontrolled hypertension
  • Uncontrolled endocrine or metabolic disease known to influence serum lipids or lipoproteins
  • Active or chronic hepatobiliary, hepatic, or gall bladder disease
  • History of mental instability, drug/alcohol abuse within the past five years or major psychiatric illness inadequately controlled and unstable
  • History of ileal bypass, gastric bypass, or other significant condition associated with malabsorption
  • Human immunodeficiency virus (HIV) positive
  • History of malignancy ≤5 years
  • Donated blood products or has had phlebotomy of >300 mL within 8 weeks or intends to donate 250 mL of blood products or receive blood products within the projected duration of the study
  • Currently taking medications that are potent inhibitors or inducers of cytochrome P450 3A4 (CYP3A) (including but not limited to cyclosporine, systemic itraconazole or ketoconazole, erythromycin, clarithromycin, or telithromycin, nefazodone, protease inhibitors, carbamazepine, phenobarbital, phenytoin, rifabutin, rifampin, St John's wort) or has discontinued treatment <3 weeks prior
  • Consumes more than 2 alcoholic drinks per day
  • Currently participating or has participated in a study with an investigational compound or device within 3 months
  • Receiving treatment with systemic corticosteroids or taking systemic anabolic agents

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Experimental

    Experimental

    Placebo Comparator

    Arm Label

    Anacetrapib 100 mg

    Anacetrapib 25 mg

    Placebo

    Arm Description

    Outcomes

    Primary Outcome Measures

    Percent Change from Baseline in LDL-C (beta-quantification [BQ] method)
    Percent Change from Baseline in HDL-C
    Number of Participants with Alanine Transaminase (ALT) or Aspartate Aminotransferase (AST) Consecutive Elevations ≥3xULN (Upper Limit of Normal)
    Number of Participants with Creatine Phosphokinase Elevations ≥10xULN with or without Muscle Symptoms
    Number of Participants with Sodium, Chloride, or Bicarbonate Elevations >ULN or Potassium Levels <LLN (Lower Limit of Normal)
    Number of Participants with Pre-specified Adjudicated Cardiovascular Serious Adverse Events or Death from Any Cause
    Number of Participants with Significant Increase in Blood Pressure

    Secondary Outcome Measures

    Percent change from Baseline in non-HDL-C
    Percent Change from Baseline in Apolipoprotein B (Apo-B)
    Percent Change from Baseline in Apolipoprotein A-I (Apo-A-I)
    Percent Change from Baseline in Lipoprotein(a) (lp[a])
    Percent Change from Baseline in HDL-C Among Participants with Low HDL-C at LDL-C goal

    Full Information

    First Posted
    October 26, 2012
    Last Updated
    April 13, 2017
    Sponsor
    Merck Sharp & Dohme LLC
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    1. Study Identification

    Unique Protocol Identification Number
    NCT01717300
    Brief Title
    A Study of the Safety and Efficacy of Anacetrapib (MK-0859) When Added to Ongoing Statin Therapy (MK-0859-021)
    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
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    April 2017
    Overall Recruitment Status
    Completed
    Study Start Date
    November 6, 2012 (Actual)
    Primary Completion Date
    October 29, 2014 (Actual)
    Study Completion Date
    October 29, 2014 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Merck Sharp & Dohme LLC

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Hypercholesterolemia

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 3
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantInvestigator
    Allocation
    Randomized
    Enrollment
    459 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Anacetrapib 100 mg
    Arm Type
    Experimental
    Arm Title
    Anacetrapib 25 mg
    Arm Type
    Experimental
    Arm Title
    Placebo
    Arm Type
    Placebo Comparator
    Intervention Type
    Drug
    Intervention Name(s)
    Anacetrapib 100 mg
    Other Intervention Name(s)
    MK-0859
    Intervention Description
    100 mg tablet, oral, once daily for 24 weeks
    Intervention Type
    Drug
    Intervention Name(s)
    Placebo for anacetrapib 100 mg
    Intervention Description
    Placebo tablet, orally, once daily for 24 weeks
    Intervention Type
    Drug
    Intervention Name(s)
    Anacetrapib 25 mg
    Other Intervention Name(s)
    MK-0859
    Intervention Description
    25 mg tablet, oral, once daily for 24 weeks
    Intervention Type
    Drug
    Intervention Name(s)
    Placebo for anacetrapib 25 mg
    Intervention Description
    Placebo tablet, orally, once daily for 24 weeks
    Primary Outcome Measure Information:
    Title
    Percent Change from Baseline in LDL-C (beta-quantification [BQ] method)
    Time Frame
    Baseline and Week 24
    Title
    Percent Change from Baseline in HDL-C
    Time Frame
    Baseline and Week 24
    Title
    Number of Participants with Alanine Transaminase (ALT) or Aspartate Aminotransferase (AST) Consecutive Elevations ≥3xULN (Upper Limit of Normal)
    Time Frame
    24 Weeks
    Title
    Number of Participants with Creatine Phosphokinase Elevations ≥10xULN with or without Muscle Symptoms
    Time Frame
    24 weeks
    Title
    Number of Participants with Sodium, Chloride, or Bicarbonate Elevations >ULN or Potassium Levels <LLN (Lower Limit of Normal)
    Time Frame
    24 weeks
    Title
    Number of Participants with Pre-specified Adjudicated Cardiovascular Serious Adverse Events or Death from Any Cause
    Time Frame
    24 weeks
    Title
    Number of Participants with Significant Increase in Blood Pressure
    Time Frame
    24 weeks
    Secondary Outcome Measure Information:
    Title
    Percent change from Baseline in non-HDL-C
    Time Frame
    Baseline and Week 24
    Title
    Percent Change from Baseline in Apolipoprotein B (Apo-B)
    Time Frame
    Baseline and Week 24
    Title
    Percent Change from Baseline in Apolipoprotein A-I (Apo-A-I)
    Time Frame
    Baseline and Week 24
    Title
    Percent Change from Baseline in Lipoprotein(a) (lp[a])
    Time Frame
    Baseline and Week 24
    Title
    Percent Change from Baseline in HDL-C Among Participants with Low HDL-C at LDL-C goal
    Time Frame
    Baseline and Week 24

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    80 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: If female, cannot be of reproductive potential Have been treated with an optimal dose of statin for at least 6 weeks Coronary heart disease (CHD) or other atherosclerotic vascular disease with multiple risk factors (including diabetes, metabolic syndrome) and/or high LDL-C/low HDL-C, or needing to meet a specific LDL-C/HDL-C goal Exclusion Criteria: Previously participated in a study with a cholesteryl ester transfer protein (CETP) inhibitor Homozygous familial hypercholesterolemia Severe chronic heart failure Uncontrolled cardiac arrhythmias, myocardial infarction (MI), percutaneous coronary intervention (PCI), coronary artery by-pass graft (CABG), unstable angina, or stroke within 3 months Uncontrolled hypertension Uncontrolled endocrine or metabolic disease known to influence serum lipids or lipoproteins Active or chronic hepatobiliary, hepatic, or gall bladder disease History of mental instability, drug/alcohol abuse within the past five years or major psychiatric illness inadequately controlled and unstable History of ileal bypass, gastric bypass, or other significant condition associated with malabsorption Human immunodeficiency virus (HIV) positive History of malignancy ≤5 years Donated blood products or has had phlebotomy of >300 mL within 8 weeks or intends to donate 250 mL of blood products or receive blood products within the projected duration of the study Currently taking medications that are potent inhibitors or inducers of cytochrome P450 3A4 (CYP3A) (including but not limited to cyclosporine, systemic itraconazole or ketoconazole, erythromycin, clarithromycin, or telithromycin, nefazodone, protease inhibitors, carbamazepine, phenobarbital, phenytoin, rifabutin, rifampin, St John's wort) or has discontinued treatment <3 weeks prior Consumes more than 2 alcoholic drinks per day Currently participating or has participated in a study with an investigational compound or device within 3 months Receiving treatment with systemic corticosteroids or taking systemic anabolic agents

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    27956003
    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.
    Results Reference
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    A Study of the Safety and Efficacy of Anacetrapib (MK-0859) When Added to Ongoing Statin Therapy (MK-0859-021)

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