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Study to Assess the Tolerability and Efficacy of Anacetrapib (MK-0859) Co-Administered With Statin in Participants With Heterozygous Familial Hypercholesterolemia (MK-0859-020) (REALIZE)

Primary Purpose

Hyperlipoproteinemia Type II, Hypercholesterolemia, Familial

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

About this trial

This is an interventional treatment trial for Hyperlipoproteinemia Type II

Eligibility Criteria

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

Inclusion Criteria:

  • If of reproductive potential, must agree to remain abstinent or use (or have their partner use) 2 acceptable methods of birth control for the duration of the study
  • Diagnosed with Heterozygous Familial Hypercholesterolemia (HeFH)
  • Have been treated with an optimal dose of statin for at least 6 weeks

Exclusion Criteria:

  • Received treatment with low-density lipoprotein (LDL) apheresis within 4 weeks of screening or expect to undergo treatment with LDL apheresis during the course of the study
  • Homozygous familial hypercholesterolemia
  • Severe chronic heart failure
  • Uncontrolled hypertension
  • Uncontrolled cardiac arrhythmias, myocardial infarction (MI), percutaneous coronary intervention (PCI), coronary artery bypass graft (CABG), unstable angina, or stroke within 3 months
  • Uncontrolled endocrine or metabolic disease known to influence serum lipids or lipoproteins
  • Active or chronic hepatobiliary, hepatic, or gall bladder disease
  • Pregnant or breast-feeding, or plans to become pregnant during the study or within 2 years after stopping study medication
  • 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 Type

    Experimental

    Placebo Comparator

    Arm Label

    Anacetrapib

    Placebo

    Arm Description

    Participants were administered one tablet of 100 mg anacetrapib orally once daily with a meal for 52 weeks during the treatment period.

    Participants were administered one matching placebo tablet orally once daily with a meal for 52 weeks during the treatment period.

    Outcomes

    Primary Outcome Measures

    Percent Change From Baseline in Low-Density Lipoprotein Cholesterol (LDL-C) - Treatment Phase
    LDL-C levels were measured at baseline and week 52 (or at discontinuation) using a beta quantification method. The Treatment Phase was the period from the date of the participant's first dose of study treatment (randomization visit, Visit 3) to the participant's last visit on treatment (discontinuation visit or Visit 8 [Week 52]).
    Percentage of Participants With Any Adverse Event - Treatment Phase
    An adverse event (AE) or experience was any unfavorable and unintended change in the structure (signs), function (symptoms), or chemistry (laboratory data) of the body temporally associated with any use of a study treatment, whether or not considered related to the use of the study treatment. Any worsening of a preexisting condition which was temporally associated with the use of the study treatment is also an AE. The percentage of participants with any adverse event during the treatment phase is presented.
    Percentage of Participants With Any Treatment-Related Adverse Event - Treatment Phase
    An AE was defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study treatment, whether or not considered related to the use of the treatment. Any worsening of a preexisting condition which was temporally associated with the use of the study treatment was also an AE. AEs reported by the investigator as definitely, probably or possibly related to study treatment were considered treatment-related. The percentage of participants with any treatment-related adverse event during the treatment phase is presented.
    Percentage of Participants With Any Serious Adverse Event - Treatment Phase
    A serious adverse experience (SAE) was any adverse event that occurred at any dose that resulted in death or was life threatening, resulted in a persistent or significant disability/incapacity, resulted in or prolonged an existing inpatient hospitalization, or was a congenital anomaly/birth defect. The percentage of participants with any serious adverse event during the treatment phase is presented.
    Percentage of Participants Discontinuing Study Treatment Due to an Adverse Event - Treatment Phase
    An adverse event (AE) was defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study treatment, whether or not considered related to the use of the drug. Any worsening of a preexisting condition which was temporally associated with the use of the study drug was also an AE. The percentage of participants who discontinued study treatment due to an AE during the treatment phase is presented.
    Percentage of Participants With Changes in Systolic Blood Pressure (SBP) >= 10 mm Hg
    Participants had SBP assessed at baseline and throughout the 52-week treatment period. Percentage of participants who had a SBP reading that was >= 10 mm Hg higher than their baseline SBP for any assessment performed during the treatment phase is presented.
    Percentage of Participants With Changes in SBP >= 15 mm Hg
    Participants had SBP assessed at baseline and throughout the 52-week treatment period. The percentage of participants who had a SBP reading that was >= 15 mm Hg higher than their baseline SBP for any assessment performed during the treatment phase is presented.
    Percentage of Participants With Changes in Diastolic Blood Pressure (DBP) >= 10 mm Hg
    Participants had DBP assessed at baseline and throughout the 52-week treatment period. The percentage of participants who had a DBP reading that was >= 10 mm Hg higher than their baseline DBP for any assessment performed during the treatment phase is presented.
    Percentage of Participants With Sodium Levels > Upper Limit of Normal (ULN)
    Participants had sodium levels assessed throughout the 52-week treatment period. The percentage of participants who had any sodium level that was greater than the ULN of 145 mEq/L during the treatment phase is presented.
    Percentage of Participants With Chloride Levels > ULN
    Participants had chloride levels assessed throughout the 52-week treatment period. The percentage of participants who had any chloride level that was > the ULN of 110 mEq/L during the treatment phase is presented.
    Percentage of Participants With Potassium Levels < Lower Limit of Normal (LLN)
    Participants had potassium levels assessed throughout the 52-week treatment period. The percentage of participants who had any potassium level that was < the LLN of 3.5 mEq/L during the treatment phase is presented.
    Percentage of Participants With Bicarbonate Levels > ULN
    Participants had bicarbonate levels assessed throughout the 52-week treatment period. The percentage of participants who had any bicarbonate level that was > the ULN of 33 mEq/L during the treatment phase is presented.
    Percentage of Participants With Consecutive Changes in Alanine Aminotransferase (ALT) and/or Aspartate Aminotransferase (AST) of >=3 x ULN
    Participants had AST and ALT levels assessed throughout the 52-week treatment period. The percentage of participants who had 2 consecutive assessments of either AST or ALT that were 3 x ULN or greater during the treatment phase is presented.
    Percentage of Participants With Creatine Kinase (CK) Level >=10 x ULN
    Participants had CK levels assessed throughout the 52-week treatment period. The percentage of participants who had any CK level that was >=10 x ULN during the treatment phase is presented.
    Percentage of Participants With CK Level >=10 x ULN With Muscle Spasms
    Participants had CK levels assessed throughout the 52-week treatment period. The percentage of participants who had any CK level that was >=10 x ULN and had associated muscle spasms during the treatment phase is presented.
    Percentage of Participants Adjudicated Cardiovascular (CV) SAE
    An AE or suspected adverse reaction was considered an SAE if it resulted in any of the following outcomes: death, a life-threatening adverse event, inpatient hospitalization or prolongation of existing hospitalization, a persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions, or a congenital anomaly/birth defect. All events were adjudicated by an expert committee independent of the Sponsor. The percentage of participants that experienced adjudicated SAEs of CV death, non-fatal stroke, non-fatal myocardial infarction, or unstable angina during the treatment phase is presented.
    Percentage of Participants Who Died From Any Cause - Treatment Phase
    The percentage of participants who died from any cause during the treatment phase is presented. All deaths were adjudicated by an expert committee independent of the Sponsor.

    Secondary Outcome Measures

    Percent Change From Baseline in High-Density Lipoprotein Cholesterol Levels
    The efficacy of adding anacetrapib 100 mg relative to placebo on plasma concentrations of high-density lipoprotein cholesterol (HDL-C) was evaluated at Week 0 (start of treatment phase) and Week 52 (end of treatment phase) or at discontinuation.
    Percent Change From Baseline in Non-High-Density Lipoprotein Cholesterol Levels
    The efficacy of adding anacetrapib 100 mg was evaluated relative to placebo on plasma concentrations of non-high-density lipoprotein cholesterol (HDL-C) for the FAS population at Week 0 (start of treatment phase) and Week 52 (end of treatment phase) or at discontinuation.
    Percent Change From Baseline in Apolipoprotein (Apo) B Levels
    The efficacy of adding anacetrapib 100 mg was evaluated relative to placebo on plasma concentrations of apolipoprotein (Apo) B for the FAS population at Week 0 (start of treatment phase) and Week 52 (end of treatment phase) or at discontinuation.
    Percent Change From Baseline in Apolipoprotein (Apo) A-1 Levels
    The efficacy of adding anacetrapib 100 mg was evaluated relative to placebo on plasma concentrations of Apo A-1 for the FAS population at Week 0 (start of treatment phase) and Week 52 (end of treatment phase) or at discontinuation.
    Percent Change From Baseline in Lipoprotein(a) (Lp[a]) Levels
    The efficacy of adding anacetrapib 100 mg was evaluated relative to placebo on plasma concentrations of lipoprotein(a) (Lp[a]) for the FAS population at Week 0 (start of treatment phase) and Week 52 (end of treatment phase) or at discontinuation.

    Full Information

    First Posted
    January 30, 2012
    Last Updated
    September 27, 2019
    Sponsor
    Merck Sharp & Dohme LLC
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    1. Study Identification

    Unique Protocol Identification Number
    NCT01524289
    Brief Title
    Study to Assess the Tolerability and Efficacy of Anacetrapib (MK-0859) Co-Administered With Statin in Participants With Heterozygous Familial Hypercholesterolemia (MK-0859-020)
    Acronym
    REALIZE
    Official Title
    A 1-Year, 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 Heterozygous Familial Hypercholesterolemia
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2019
    Overall Recruitment Status
    Completed
    Study Start Date
    February 3, 2012 (Actual)
    Primary Completion Date
    February 12, 2014 (Actual)
    Study Completion Date
    November 13, 2018 (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
    The objective of this study is to evaluate the efficacy and tolerability of adding anacetrapib to ongoing statin therapy in participants with heterozygous familial hypercholesterolemia (HeFH).

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Hyperlipoproteinemia Type II, Hypercholesterolemia, Familial

    7. Study Design

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

    8. Arms, Groups, and Interventions

    Arm Title
    Anacetrapib
    Arm Type
    Experimental
    Arm Description
    Participants were administered one tablet of 100 mg anacetrapib orally once daily with a meal for 52 weeks during the treatment period.
    Arm Title
    Placebo
    Arm Type
    Placebo Comparator
    Arm Description
    Participants were administered one matching placebo tablet orally once daily with a meal for 52 weeks during the treatment period.
    Intervention Type
    Drug
    Intervention Name(s)
    Anacetrapib
    Other Intervention Name(s)
    MK-0859
    Intervention Description
    One oral tablet, orally once daily for 52 weeks
    Intervention Type
    Drug
    Intervention Name(s)
    Placebo
    Intervention Description
    One oral tablet once daily for 52 weeks
    Primary Outcome Measure Information:
    Title
    Percent Change From Baseline in Low-Density Lipoprotein Cholesterol (LDL-C) - Treatment Phase
    Description
    LDL-C levels were measured at baseline and week 52 (or at discontinuation) using a beta quantification method. The Treatment Phase was the period from the date of the participant's first dose of study treatment (randomization visit, Visit 3) to the participant's last visit on treatment (discontinuation visit or Visit 8 [Week 52]).
    Time Frame
    Baseline and Week 52
    Title
    Percentage of Participants With Any Adverse Event - Treatment Phase
    Description
    An adverse event (AE) or experience was any unfavorable and unintended change in the structure (signs), function (symptoms), or chemistry (laboratory data) of the body temporally associated with any use of a study treatment, whether or not considered related to the use of the study treatment. Any worsening of a preexisting condition which was temporally associated with the use of the study treatment is also an AE. The percentage of participants with any adverse event during the treatment phase is presented.
    Time Frame
    Up to 52 weeks
    Title
    Percentage of Participants With Any Treatment-Related Adverse Event - Treatment Phase
    Description
    An AE was defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study treatment, whether or not considered related to the use of the treatment. Any worsening of a preexisting condition which was temporally associated with the use of the study treatment was also an AE. AEs reported by the investigator as definitely, probably or possibly related to study treatment were considered treatment-related. The percentage of participants with any treatment-related adverse event during the treatment phase is presented.
    Time Frame
    Up to 52 weeks
    Title
    Percentage of Participants With Any Serious Adverse Event - Treatment Phase
    Description
    A serious adverse experience (SAE) was any adverse event that occurred at any dose that resulted in death or was life threatening, resulted in a persistent or significant disability/incapacity, resulted in or prolonged an existing inpatient hospitalization, or was a congenital anomaly/birth defect. The percentage of participants with any serious adverse event during the treatment phase is presented.
    Time Frame
    Up to 52 weeks
    Title
    Percentage of Participants Discontinuing Study Treatment Due to an Adverse Event - Treatment Phase
    Description
    An adverse event (AE) was defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study treatment, whether or not considered related to the use of the drug. Any worsening of a preexisting condition which was temporally associated with the use of the study drug was also an AE. The percentage of participants who discontinued study treatment due to an AE during the treatment phase is presented.
    Time Frame
    Up to 52 weeks
    Title
    Percentage of Participants With Changes in Systolic Blood Pressure (SBP) >= 10 mm Hg
    Description
    Participants had SBP assessed at baseline and throughout the 52-week treatment period. Percentage of participants who had a SBP reading that was >= 10 mm Hg higher than their baseline SBP for any assessment performed during the treatment phase is presented.
    Time Frame
    Up to 52 weeks
    Title
    Percentage of Participants With Changes in SBP >= 15 mm Hg
    Description
    Participants had SBP assessed at baseline and throughout the 52-week treatment period. The percentage of participants who had a SBP reading that was >= 15 mm Hg higher than their baseline SBP for any assessment performed during the treatment phase is presented.
    Time Frame
    Up to 52 weeks
    Title
    Percentage of Participants With Changes in Diastolic Blood Pressure (DBP) >= 10 mm Hg
    Description
    Participants had DBP assessed at baseline and throughout the 52-week treatment period. The percentage of participants who had a DBP reading that was >= 10 mm Hg higher than their baseline DBP for any assessment performed during the treatment phase is presented.
    Time Frame
    Up to 52 weeks
    Title
    Percentage of Participants With Sodium Levels > Upper Limit of Normal (ULN)
    Description
    Participants had sodium levels assessed throughout the 52-week treatment period. The percentage of participants who had any sodium level that was greater than the ULN of 145 mEq/L during the treatment phase is presented.
    Time Frame
    Up to 52 weeks
    Title
    Percentage of Participants With Chloride Levels > ULN
    Description
    Participants had chloride levels assessed throughout the 52-week treatment period. The percentage of participants who had any chloride level that was > the ULN of 110 mEq/L during the treatment phase is presented.
    Time Frame
    Up to 52 weeks
    Title
    Percentage of Participants With Potassium Levels < Lower Limit of Normal (LLN)
    Description
    Participants had potassium levels assessed throughout the 52-week treatment period. The percentage of participants who had any potassium level that was < the LLN of 3.5 mEq/L during the treatment phase is presented.
    Time Frame
    Up to 52 weeks
    Title
    Percentage of Participants With Bicarbonate Levels > ULN
    Description
    Participants had bicarbonate levels assessed throughout the 52-week treatment period. The percentage of participants who had any bicarbonate level that was > the ULN of 33 mEq/L during the treatment phase is presented.
    Time Frame
    Up to 52 weeks
    Title
    Percentage of Participants With Consecutive Changes in Alanine Aminotransferase (ALT) and/or Aspartate Aminotransferase (AST) of >=3 x ULN
    Description
    Participants had AST and ALT levels assessed throughout the 52-week treatment period. The percentage of participants who had 2 consecutive assessments of either AST or ALT that were 3 x ULN or greater during the treatment phase is presented.
    Time Frame
    Up to 52 weeks
    Title
    Percentage of Participants With Creatine Kinase (CK) Level >=10 x ULN
    Description
    Participants had CK levels assessed throughout the 52-week treatment period. The percentage of participants who had any CK level that was >=10 x ULN during the treatment phase is presented.
    Time Frame
    Up to 52 weeks
    Title
    Percentage of Participants With CK Level >=10 x ULN With Muscle Spasms
    Description
    Participants had CK levels assessed throughout the 52-week treatment period. The percentage of participants who had any CK level that was >=10 x ULN and had associated muscle spasms during the treatment phase is presented.
    Time Frame
    Up to 52 weeks
    Title
    Percentage of Participants Adjudicated Cardiovascular (CV) SAE
    Description
    An AE or suspected adverse reaction was considered an SAE if it resulted in any of the following outcomes: death, a life-threatening adverse event, inpatient hospitalization or prolongation of existing hospitalization, a persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions, or a congenital anomaly/birth defect. All events were adjudicated by an expert committee independent of the Sponsor. The percentage of participants that experienced adjudicated SAEs of CV death, non-fatal stroke, non-fatal myocardial infarction, or unstable angina during the treatment phase is presented.
    Time Frame
    Up to 52 weeks
    Title
    Percentage of Participants Who Died From Any Cause - Treatment Phase
    Description
    The percentage of participants who died from any cause during the treatment phase is presented. All deaths were adjudicated by an expert committee independent of the Sponsor.
    Time Frame
    Up to 52 weeks
    Secondary Outcome Measure Information:
    Title
    Percent Change From Baseline in High-Density Lipoprotein Cholesterol Levels
    Description
    The efficacy of adding anacetrapib 100 mg relative to placebo on plasma concentrations of high-density lipoprotein cholesterol (HDL-C) was evaluated at Week 0 (start of treatment phase) and Week 52 (end of treatment phase) or at discontinuation.
    Time Frame
    Baseline and Week 52
    Title
    Percent Change From Baseline in Non-High-Density Lipoprotein Cholesterol Levels
    Description
    The efficacy of adding anacetrapib 100 mg was evaluated relative to placebo on plasma concentrations of non-high-density lipoprotein cholesterol (HDL-C) for the FAS population at Week 0 (start of treatment phase) and Week 52 (end of treatment phase) or at discontinuation.
    Time Frame
    Baseline and Week 52
    Title
    Percent Change From Baseline in Apolipoprotein (Apo) B Levels
    Description
    The efficacy of adding anacetrapib 100 mg was evaluated relative to placebo on plasma concentrations of apolipoprotein (Apo) B for the FAS population at Week 0 (start of treatment phase) and Week 52 (end of treatment phase) or at discontinuation.
    Time Frame
    Baseline and Week 52
    Title
    Percent Change From Baseline in Apolipoprotein (Apo) A-1 Levels
    Description
    The efficacy of adding anacetrapib 100 mg was evaluated relative to placebo on plasma concentrations of Apo A-1 for the FAS population at Week 0 (start of treatment phase) and Week 52 (end of treatment phase) or at discontinuation.
    Time Frame
    Baseline and Week 52
    Title
    Percent Change From Baseline in Lipoprotein(a) (Lp[a]) Levels
    Description
    The efficacy of adding anacetrapib 100 mg was evaluated relative to placebo on plasma concentrations of lipoprotein(a) (Lp[a]) for the FAS population at Week 0 (start of treatment phase) and Week 52 (end of treatment phase) or at discontinuation.
    Time Frame
    Baseline and Week 52

    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 of reproductive potential, must agree to remain abstinent or use (or have their partner use) 2 acceptable methods of birth control for the duration of the study Diagnosed with Heterozygous Familial Hypercholesterolemia (HeFH) Have been treated with an optimal dose of statin for at least 6 weeks Exclusion Criteria: Received treatment with low-density lipoprotein (LDL) apheresis within 4 weeks of screening or expect to undergo treatment with LDL apheresis during the course of the study Homozygous familial hypercholesterolemia Severe chronic heart failure Uncontrolled hypertension Uncontrolled cardiac arrhythmias, myocardial infarction (MI), percutaneous coronary intervention (PCI), coronary artery bypass graft (CABG), unstable angina, or stroke within 3 months Uncontrolled endocrine or metabolic disease known to influence serum lipids or lipoproteins Active or chronic hepatobiliary, hepatic, or gall bladder disease Pregnant or breast-feeding, or plans to become pregnant during the study or within 2 years after stopping study medication 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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Medical Director
    Organizational Affiliation
    Merck Sharp & Dohme LLC
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Plan to Share IPD
    Yes
    IPD Sharing Plan Description
    http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf
    IPD Sharing URL
    http://engagezone.msd.com/ds_documentation.php
    Citations:
    PubMed Identifier
    25743173
    Citation
    Kastelein JJ, Besseling J, Shah S, Bergeron J, Langslet G, Hovingh GK, Al-Saady N, Koeijvoets M, Hunter J, Johnson-Levonas AO, Fable J, Sapre A, Mitchel Y. Anacetrapib as lipid-modifying therapy in patients with heterozygous familial hypercholesterolaemia (REALIZE): a randomised, double-blind, placebo-controlled, phase 3 study. Lancet. 2015 May 30;385(9983):2153-61. doi: 10.1016/S0140-6736(14)62115-2. Epub 2015 Mar 3.
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    Study to Assess the Tolerability and Efficacy of Anacetrapib (MK-0859) Co-Administered With Statin in Participants With Heterozygous Familial Hypercholesterolemia (MK-0859-020)

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