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    Clinical Trial Results:
    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

    Due to the EudraCT – Results system being out of service between 31 July 2015 and 12 January 2016, these results have been published in compliance with revised timelines.
    Summary
    EudraCT number
    		 2012-003110-14
    Trial protocol
    		 NL   GB   DE   HU   ES   SK   BG   RO  
    Global end of trial date
    29 Oct 2014

    Results information
    Results version number
    		 v1(current)
    This version publication date
    26 Feb 2016
    First version publication date
    26 Feb 2016
    Other versions

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    MK-0859-021
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT01717300
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Merck Sharp & Dohme Corp.
    Sponsor organisation address
    2000 Galloping Hill Road, Kenilworth, United States, 07033
    Public contact
    Clinical Trials Disclosure, Merck Sharp & Dohme Corp., ClinicalTrialsDisclosure@merck.com
    Scientific contact
    Clinical Trials Disclosure, Merck Sharp & Dohme Corp., ClinicalTrialsDisclosure@merck.com
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    29 Oct 2014
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    29 Oct 2014
    Global end of trial reached?
    Yes
    Global end of trial date
    29 Oct 2014
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    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.
    Protection of trial subjects
    This study was conducted in conformance with Good Clinical Practice standards and applicable country and/or local statutes and regulations regarding ethical committee review, informed consent, and the protection of human subjects participating in biomedical research.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    06 Nov 2012
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Bulgaria: 22
    Country: Number of subjects enrolled
    Canada: 16
    Country: Number of subjects enrolled
    Germany: 17
    Country: Number of subjects enrolled
    Spain: 15
    Country: Number of subjects enrolled
    United Kingdom: 24
    Country: Number of subjects enrolled
    Hungary: 32
    Country: Number of subjects enrolled
    Israel: 38
    Country: Number of subjects enrolled
    Netherlands: 28
    Country: Number of subjects enrolled
    Poland: 19
    Country: Number of subjects enrolled
    Puerto Rico: 20
    Country: Number of subjects enrolled
    Romania: 26
    Country: Number of subjects enrolled
    Slovakia: 47
    Country: Number of subjects enrolled
    United States: 155
    Worldwide total number of subjects
    459
    EEA total number of subjects
    230
    Number of subjects enrolled per age group
    In utero
    0
    Preterm newborn - gestational age < 37 wk
    0
    Newborns (0-27 days)
    0
    Infants and toddlers (28 days-23 months)
    0
    Children (2-11 years)
    0
    Adolescents (12-17 years)
    0
    Adults (18-64 years)
    289
    From 65 to 84 years
    170
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Participants were to complete a 2-week placebo run-in, a 24-week treatment period, and a 12-week safety follow-up.

    Pre-assignment
    Screening details
    		 Adult participants, with hypercholesterolemia or low HDL-C who had been treated with an appropriate statin dose with or without other lipid-modifying therapy (LMT) for at least 6 weeks and had not met their LDL-C goal. Additionally, participants on statin with or without other LMT with low HDL-C and LDL-C at goal were eligible to participate.

    Period 1
    Period 1 title
    Treatment Period
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Anacetrapib 25 mg
    Arm description
    		 One tablet of anacetrapib 25 mg and one tablet of placebo taken once daily with a meal for 24 weeks
    Arm type
    		 Experimental

    Investigational medicinal product name
    Anacetrapib
    Investigational medicinal product code
    Other name
    MK-0859
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    One tablet once daily with a meal for 24 weeks

    Investigational medicinal product name
    Placebo to match anacetrapib
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    One or two placebo tablets once daily for 24 weeks

    Arm title
    		 Anacetrapib 100 mg
    Arm description
    		 One tablet of anacetrapib 100 mg and one tablet of placebo taken once daily with a meal for 24 weeks
    Arm type
    		 Experimental

    Investigational medicinal product name
    Anacetrapib
    Investigational medicinal product code
    Other name
    MK-0859
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    One tablet once daily with a meal for 24 weeks

    Investigational medicinal product name
    Placebo to match anacetrapib
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    One or two placebo tablets once daily for 24 weeks

    Arm title
    		 Placebo
    Arm description
    		 Two matching placebo tablets once daily with a meal for 24 weeks
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo to match anacetrapib
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    One or two placebo tablets once daily for 24 weeks

    Number of subjects in period 1
    		Anacetrapib 25 mg Anacetrapib 100 mg Placebo
    Started
    152
    153
    154
    Completed
    136
    140
    140
    Not completed
    16
    13
    14
         Adverse event, serious fatal
    1
    -
    -
         Consent withdrawn by subject
    7
    7
    3
         Physician decision
    -
    -
    1
         Adverse event, non-fatal
    5
    4
    9
         Non-compliance with study drug
    -
    -
    1
         Lost to follow-up
    -
    1
    -
         Protocol deviation
    3
    1
    -
    Period 2
    Period 2 title
    Follow-up
    Is this the baseline period?
    		 No
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Anacetrapib 25 mg-Follow up
    Arm description
    		 Participants who completed treatment period and participants who were discontinued during treatment period (non-completers) who were administered anacetrapib 25 mg in treatment period and entered Follow-up period. No study drug was administered during Follow-up Period.
    Arm type
    		 No intervention

    Investigational medicinal product name
    No investigational medicinal product assigned in this arm
    Arm title
    		 Anacetrapib 100 mg-Follow-up
    Arm description
    		 Participants who completed treatment period and participants who were discontinued during treatment period (non-completers) who were administered anacetrapib 100 mg in treatment period and entered Follow-up period. No study drug was administered during Follow-up Period.
    Arm type
    		 No intervention

    Investigational medicinal product name
    No investigational medicinal product assigned in this arm
    Arm title
    		 Placebo-Follow-up
    Arm description
    		 Participants who completed treatment period and participants who were discontinued during treatment period (non-completers) who were administered placebo in treatment period and entered Follow-up period. No study drug was administered during Follow-up Period.
    Arm type
    		 No intervention

    Investigational medicinal product name
    No investigational medicinal product assigned in this arm
    Number of subjects in period 2
    		Anacetrapib 25 mg-Follow up Anacetrapib 100 mg-Follow-up Placebo-Follow-up
    Started
    136
    140
    140
    Completed
    144
    148
    152
    Not completed
    1
    4
    1
         Adverse event, serious fatal
    -
    2
    -
         Consent withdrawn by subject
    -
    1
    -
         Physician decision
    -
    -
    1
         Adverse event, non-fatal
    1
    -
    -
         Lost to follow-up
    -
    1
    -
    Joined
    9
    12
    13
         Non-completers from Treatment Period
    9
    12
    13

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Anacetrapib 25 mg
    Reporting group description
    		 One tablet of anacetrapib 25 mg and one tablet of placebo taken once daily with a meal for 24 weeks

    Reporting group title
    Anacetrapib 100 mg
    Reporting group description
    		 One tablet of anacetrapib 100 mg and one tablet of placebo taken once daily with a meal for 24 weeks

    Reporting group title
    Placebo
    Reporting group description
    		 Two matching placebo tablets once daily with a meal for 24 weeks

    Reporting group values
    		 Anacetrapib 25 mg Anacetrapib 100 mg Placebo Total
    Number of subjects
    		 152 153 154 459
    Age Categorical
    Units: Subjects
    Age Continuous
    Units: years
        arithmetic mean (standard deviation)
    		 61.9 ( 9.1 ) 58.7 ( 9.6 ) 60.3 ( 8.9 ) -
    Gender Categorical
    Units: Subjects
        Female
    		 102 101 108 311
        Male
    		 50 52 46 148

    End points

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    End points reporting groups
    Reporting group title
    Anacetrapib 25 mg
    Reporting group description
    		 One tablet of anacetrapib 25 mg and one tablet of placebo taken once daily with a meal for 24 weeks

    Reporting group title
    Anacetrapib 100 mg
    Reporting group description
    		 One tablet of anacetrapib 100 mg and one tablet of placebo taken once daily with a meal for 24 weeks

    Reporting group title
    Placebo
    Reporting group description
    		 Two matching placebo tablets once daily with a meal for 24 weeks
    Reporting group title
    Anacetrapib 25 mg-Follow up
    Reporting group description
    		 Participants who completed treatment period and participants who were discontinued during treatment period (non-completers) who were administered anacetrapib 25 mg in treatment period and entered Follow-up period. No study drug was administered during Follow-up Period.

    Reporting group title
    Anacetrapib 100 mg-Follow-up
    Reporting group description
    		 Participants who completed treatment period and participants who were discontinued during treatment period (non-completers) who were administered anacetrapib 100 mg in treatment period and entered Follow-up period. No study drug was administered during Follow-up Period.

    Reporting group title
    Placebo-Follow-up
    Reporting group description
    		 Participants who completed treatment period and participants who were discontinued during treatment period (non-completers) who were administered placebo in treatment period and entered Follow-up period. No study drug was administered during Follow-up Period.

    Subject analysis set title
    Anacetrapib 25 mg- Efficacy Population
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Participants who received at least 1 dose of study treatment had baseline data and at least 1 post-dose observation for the analysis endpoint.

    Subject analysis set title
    Anacetrapib 100 mg- Efficacy Population
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Participants who received at least 1 dose of study treatment had baseline data and at least 1 post-dose observation for the analysis endpoint.

    Subject analysis set title
    Placebo - Efficacy Population
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Participants who received at least 1 dose of study treatment had baseline data and at least 1 post-dose observation for the analysis endpoint.

    Primary: Percentage Change From Baseline in LDL-C - Treatment Period

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    End point title
    		 Percentage Change From Baseline in LDL-C - Treatment Period
    End point description
    LDL-C levels measured at baseline and after 24 weeks of treatment using beta quantification method
    End point type
    Primary
    End point timeframe
    Baseline and Week 24
    End point values
    		 Anacetrapib 25 mg- Efficacy Population Anacetrapib 100 mg- Efficacy Population Placebo - Efficacy Population
    Number of subjects analysed
    126
    133
    133
    Units: Percentage Change
        least squares mean (confidence interval 95%)
    -21.9 (-27.9 to -15.9)
    -28 (-33.7 to -22.3)
    0.9 (-4.9 to 6.7)
    Statistical analysis title
    		 Comparison of Percentage Change from Baseline
    Statistical analysis description
    Between group comparison of percentage change from baseline performed using Constrained Longitudinal Data Analysis (cLDA) model with terms for treatment, time, statin stratum and the interaction of time by treatment. Analysis population defined as participants who received at least 1 dose of study treatment and had baseline and at least 1 post-randomization observation for the analysis endpoint.
    Comparison groups
    Anacetrapib 25 mg- Efficacy Population v Placebo - Efficacy Population
    Number of subjects included in analysis
    259
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001
    Method
    		 Constrained Longitudinal Data Analysis
    Parameter type
    		 Difference in Least Squares Mean
    Point estimate
    -22.8
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -30.4
         upper limit
    		 -15.1
    Statistical analysis title
    		 Comparison of Percentage Change from Baseline
    Statistical analysis description
    Between group comparison of percentage change from baseline performed using Constrained Longitudinal Data Analysis (cLDA) model with terms for treatment, time, statin stratum and the interaction of time by treatment. Analysis population defined as participants who received at least 1 dose of study treatment and had baseline and at least 1 post-randomization observation for the analysis endpoint.
    Comparison groups
    Anacetrapib 100 mg- Efficacy Population v Placebo - Efficacy Population
    Number of subjects included in analysis
    266
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001
    Method
    		 Constrained Longitudinal Data Analysis
    Parameter type
    		 Difference in Least Squares Mean
    Point estimate
    -28.9
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -36.4
         upper limit
    		 -21.3
    Statistical analysis title
    		 Comparison of Percent Change from Baseline
    Statistical analysis description
    Between group comparison of percent change from baseline performed using Constrained Longitudinal Data Analysis (cLDA) model with terms for treatment, time, statin stratum and the interaction of time by treatment. Analysis population defined as participants who receive at least 1 dose of study treatment and have baseline and at least 1 post-randomization observation for the analysis endpoint.
    Comparison groups
    Anacetrapib 25 mg- Efficacy Population v Anacetrapib 100 mg- Efficacy Population
    Number of subjects included in analysis
    259
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.118
    Method
    		 Constrained Longitudinal Data Analysis
    Parameter type
    		 Difference in Least Squares Means
    Point estimate
    -6.1
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -13.7
         upper limit
    		 -1.6

    Primary: Percentage Change From Baseline in HDL-C - Treatment Period

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    End point title
    		 Percentage Change From Baseline in HDL-C - Treatment Period
    End point description
    HDL-C levels measured at baseline and after 24 weeks of treatment
    End point type
    Primary
    End point timeframe
    Baseline and Week 24
    End point values
    		 Anacetrapib 25 mg- Efficacy Population Anacetrapib 100 mg- Efficacy Population Placebo - Efficacy Population
    Number of subjects analysed
    136
    138
    140
    Units: Percentage Change
        least squares mean (confidence interval 95%)
    69.4 (62.4 to 76.3)
    98.6 (91.7 to 105.4)
    3.9 (-2.9 to 10.7)
    Statistical analysis title
    		 Comparison of Percentage Change from Baseline
    Statistical analysis description
    Between group comparison of percentage change from baseline performed using Constrained Longitudinal Data Analysis (cLDA) model with terms for treatment, time, statin stratum and the interaction of time by treatment. Analysis population defined as participants who received at least 1 dose of study treatment and had baseline and at least 1 post-randomization observation for the analysis endpoint.
    Comparison groups
    Anacetrapib 25 mg- Efficacy Population v Anacetrapib 100 mg- Efficacy Population
    Number of subjects included in analysis
    274
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001
    Method
    		 Constrained Longitudinal Data Analysis
    Parameter type
    		 Difference in Least Squares Mean
    Point estimate
    65.5
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 56
         upper limit
    		 75
    Statistical analysis title
    		 Comparison of Percentage Change from Baseline
    Statistical analysis description
    Between group comparison of percentage change from baseline performed using Constrained Longitudinal Data Analysis (cLDA) model with terms for treatment, time, statin stratum and the interaction of time by treatment. Analysis population defined as participants who received at least 1 dose of study treatment and had baseline and at least 1 post-randomization observation for the analysis endpoint.
    Comparison groups
    Anacetrapib 100 mg- Efficacy Population v Placebo - Efficacy Population
    Number of subjects included in analysis
    278
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001
    Method
    		 Constrained Longitudinal Data Analysis
    Parameter type
    		 Difference in Least Squares Mean
    Point estimate
    94.7
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 85.2
         upper limit
    		 104

    Primary: Percentage of Participants With Any Adverse Event (AE) - Treatment Period

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    End point title
    		 Percentage of Participants With Any Adverse Event (AE) - Treatment Period
    End point description
    An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry ofthe body temporally associated with the use of the study drug, whether or not considered related to theuse of the drug. Any worsening of a preexisting condition which is temporally associated with the use ofthe study drug is also an AE.
    End point type
    Primary
    End point timeframe
    Up to 24 weeks
    End point values
    		 Anacetrapib 25 mg Anacetrapib 100 mg Placebo
    Number of subjects analysed
    152
    153
    154
    Units: Percentage of Participants
        number (not applicable)
    35.5
    39.9
    39
    Statistical analysis title
    		 Difference in Percentages Between Groups
    Comparison groups
    Anacetrapib 25 mg v Placebo
    Number of subjects included in analysis
    306
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    		 Miettinen and Nurminen
    Parameter type
    		 Difference in Percentages
    Point estimate
    -3.4
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -14.2
         upper limit
    		 7.4
    Statistical analysis title
    		 Difference in Percentages Between Groups
    Comparison groups
    Anacetrapib 100 mg v Placebo
    Number of subjects included in analysis
    307
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    		 Miettinen and Nurminen
    Parameter type
    		 Difference in Percentages
    Point estimate
    0.9
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -10
         upper limit
    		 11.8
    Statistical analysis title
    		 Difference in Percentages Between Groups
    Comparison groups
    Anacetrapib 25 mg v Anacetrapib 100 mg
    Number of subjects included in analysis
    305
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    		 Miettinen and Nurminen
    Parameter type
    		 Difference in Percentages
    Point estimate
    4.3
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -6.5
         upper limit
    		 15.1

    Primary: Percentage of Participants With Any Drug-related AE - Treatment Period

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    End point title
    		 Percentage of Participants With Any Drug-related AE - Treatment Period
    End point description
    An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study drug, whether or not considered related to the use of the drug. Any worsening of a preexisting condition which is temporally associated with the use of the study drug is also an AE. AEs reported by the investigator as definitely, probably, or possibly related to study drug were considered drug-related.
    End point type
    Primary
    End point timeframe
    Up to 24 weeks
    End point values
    		 Anacetrapib 25 mg Anacetrapib 100 mg Placebo
    Number of subjects analysed
    152
    153
    154
    Units: Percentage of Participants
        number (not applicable)
    2
    8.5
    5.2
    Statistical analysis title
    		 Difference in Percentages Between Groups
    Comparison groups
    Anacetrapib 100 mg v Placebo
    Number of subjects included in analysis
    307
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    		 Miettinen and Nurminen
    Parameter type
    		 Difference in Percentages
    Point estimate
    3.3
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -2.5
         upper limit
    		 9.5

    Primary: Percentage of Participants With Any Serious Adverse Event (SAE) - Treatment Period

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    End point title
    		 Percentage of Participants With Any Serious Adverse Event (SAE) - Treatment Period
    End point description
    An AE or suspected adverse reaction is considered an SAE if it results in any of the following outcomes: death, a life-threatening AE, inpatient hospitalization or prolongation of existing hospitalization, a persistent or significant incapacity or substantial disruption of the ability to conduct normal lifefunctions, or a congenital anomaly/birth defect.
    End point type
    Primary
    End point timeframe
    Up to 24 weeks
    End point values
    		 Anacetrapib 25 mg Anacetrapib 100 mg Placebo
    Number of subjects analysed
    152
    153
    154
    Units: Percentage of Participants
        number (not applicable)
    5.3
    4.6
    5.2
    Statistical analysis title
    		 Difference in Percentages Between Groups
    Comparison groups
    Anacetrapib 25 mg v Placebo
    Number of subjects included in analysis
    306
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    		 Miettinen & Nurminen
    Parameter type
    		 Difference in Percentage
    Point estimate
    0.1
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -5.3
         upper limit
    		 5.5
    Statistical analysis title
    		 Difference in Percentages Between Groups
    Comparison groups
    Anacetrapib 100 mg v Placebo
    Number of subjects included in analysis
    307
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    		 Miettinen & Nurminen
    Parameter type
    		 Difference in Percentages
    Point estimate
    -0.6
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -5.9
         upper limit
    		 4.6
    Statistical analysis title
    		 Difference in Percentages Between Groups
    Comparison groups
    Anacetrapib 25 mg v Anacetrapib 100 mg
    Number of subjects included in analysis
    305
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    		 Miettinen & Nurminen
    Parameter type
    		 Difference in Percentages
    Point estimate
    -0.7
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -6.1
         upper limit
    		 4.6

    Primary: Percentage of Participants With Any Drug-related SAE - Treatment Period

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    End point title
    		 Percentage of Participants With Any Drug-related SAE - Treatment Period
    End point description
    An AE or suspected adverse reaction is considered an SAE if it results in any of the following outcomes: death, a life-threatening AE, 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. SAEs reported by the investigator as definitely, probably or possibly related to study were considered to be drug-related.
    End point type
    Primary
    End point timeframe
    Up to 24 weeks
    End point values
    		 Anacetrapib 25 mg Anacetrapib 100 mg Placebo
    Number of subjects analysed
    152
    153
    154
    Units: Percentage of Participants
        number (not applicable)
    0
    0
    0
    Statistical analysis title
    		 Difference in Percentages Between Groups
    Comparison groups
    Anacetrapib 100 mg v Placebo
    Number of subjects included in analysis
    307
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    		 Miettinen & Nurminen
    Parameter type
    		 Difference in Percentages
    Point estimate
    0
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -2.5
         upper limit
    		 2.5

    Primary: Percentage of Participants With Any AE Leading to Discontinuation of Treatment - Treatment Period

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    End point title
    		 Percentage of Participants With Any AE Leading to Discontinuation of Treatment - Treatment Period
    End point description
    An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study drug, whether or not considered related to the use of the drug. Any worsening of a preexisting condition which is temporally associated with the use of the study drug is also an AE. Adverse Events that were reported as the cause for discontinuation of the study drug were recorded.
    End point type
    Primary
    End point timeframe
    Up to 24 weeks
    End point values
    		 Anacetrapib 25 mg Anacetrapib 100 mg Placebo
    Number of subjects analysed
    152
    153
    154
    Units: Percentage of Participants
        number (not applicable)
    3.3
    2.6
    5.8
    Statistical analysis title
    		 Difference in Percentages Between Groups
    Comparison groups
    Anacetrapib 25 mg v Placebo
    Number of subjects included in analysis
    306
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    		 Miettinen & Nurminen
    Parameter type
    		 Difference in Percentages
    Point estimate
    -2.6
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -7.9
         upper limit
    		 2.4
    Statistical analysis title
    		 Difference in Percentages Between Groups
    Comparison groups
    Anacetrapib 100 mg v Placebo
    Number of subjects included in analysis
    307
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    		 Miettinen & Nurminen
    Parameter type
    		 Difference in Percentages
    Point estimate
    -3.2
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -8.5
         upper limit
    		 1.5
    Statistical analysis title
    		 Difference in Percentages Between Groups
    Comparison groups
    Anacetrapib 25 mg v Anacetrapib 100 mg
    Number of subjects included in analysis
    305
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    		 Miettinen & Nurminen
    Parameter type
    		 Difference in Percentages
    Point estimate
    -0.7
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -5.2
         upper limit
    		 3.7

    Primary: Percentage of Participants With Elevations in Sitting Systolic Blood Pressure (SiSBP) ≥ 10 mm Hg - Treatment Period

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    End point title
    		 Percentage of Participants With Elevations in Sitting Systolic Blood Pressure (SiSBP) ≥ 10 mm Hg - Treatment Period
    End point description
    Participants had SBP assessed while sitting at baseline and throughout the 24 week treatment period. Participants who had a SiSBP reading that was ≥ 10 mm Hg higher than their baseline SiSBP for any assessment performed during the treatment period were recorded.
    End point type
    Primary
    End point timeframe
    Up to 24 weeks
    End point values
    		 Anacetrapib 25 mg Anacetrapib 100 mg Placebo
    Number of subjects analysed
    147
    153
    153
    Units: Percentage of Participants
        number (not applicable)
    37.4
    33.3
    39.9
    Statistical analysis title
    		 Difference in Percentages Between Groups
    Comparison groups
    Anacetrapib 25 mg v Placebo
    Number of subjects included in analysis
    300
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.663
    Method
    		 Miettinen and Nurminen
    Parameter type
    		 Difference in Percentages
    Point estimate
    -2.5
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -13.4
         upper limit
    		 8.6
    Statistical analysis title
    		 Difference in Percentages Between Groups
    Comparison groups
    Anacetrapib 100 mg v Placebo
    Number of subjects included in analysis
    306
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.236
    Method
    		 Miettinen and Nurminen
    Parameter type
    		 Difference in Percentages
    Point estimate
    -6.5
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -17.2
         upper limit
    		 4.3
    Statistical analysis title
    		 Difference in Percentages Between Groups
    Comparison groups
    Anacetrapib 25 mg v Anacetrapib 100 mg
    Number of subjects included in analysis
    300
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.46
    Method
    		 Miettinen and Nurminen
    Parameter type
    		 Difference in Percentages
    Point estimate
    -4.1
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -14.8
         upper limit
    		 6.7

    Primary: Percentage of Participants With Elevations in SiSBP ≥ 15 mm Hg - Treatment Period

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    End point title
    		 Percentage of Participants With Elevations in SiSBP ≥ 15 mm Hg - Treatment Period
    End point description
    Participants had SBP assessed while in sitting position at baseline and throughout the 24 week treatment period. Participants who had a SiSBP reading that was ≥ 15 mm Hg higher than their baseline SiSBP for any assessment performed during the treatment period were recorded.
    End point type
    Primary
    End point timeframe
    up to 24 weeks
    End point values
    		 Anacetrapib 25 mg Anacetrapib 100 mg Placebo
    Number of subjects analysed
    147
    153
    153
    Units: Percentage of Participants
        number (not applicable)
    19
    19.6
    22.2
    Statistical analysis title
    		 Difference in Percentages Between Groups
    Comparison groups
    Anacetrapib 25 mg v Placebo
    Number of subjects included in analysis
    300
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.498
    Method
    		 Miettinen and Nurminen
    Parameter type
    		 Difference in Percentages
    Point estimate
    -3.2
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -12.4
         upper limit
    		 6.1
    Statistical analysis title
    		 Difference in Percentages Between Groups
    Comparison groups
    Anacetrapib 100 mg v Placebo
    Number of subjects included in analysis
    306
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.575
    Method
    		 Miettinen and Nurminen
    Parameter type
    		 Difference in Percentages
    Point estimate
    -2.6
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -11.8
         upper limit
    		 6.6
    Statistical analysis title
    		 Difference in Percentages Between Groups
    Comparison groups
    Anacetrapib 25 mg v Anacetrapib 100 mg
    Number of subjects included in analysis
    300
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.902
    Method
    		 Miettinen and Nurminen
    Parameter type
    		 Difference in Percentages
    Point estimate
    0.6
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -8.5
         upper limit
    		 9.6

    Primary: Percentage of Participants With Elevations in Sitting Diastolic Blood Pressure (SiDBP) ≥ 10 mm Hg - Treatment Period

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    End point title
    		 Percentage of Participants With Elevations in Sitting Diastolic Blood Pressure (SiDBP) ≥ 10 mm Hg - Treatment Period
    End point description
    Participants had DBP assessed while in sitting position at baseline and throughout the 24 week treatment period. Participants who had a SiDBP reading that was ≥ 10 mm Hg higher than their baseline SiDBP for any assessment performed during the treatment period were recorded.
    End point type
    Primary
    End point timeframe
    up to 24 weeks
    End point values
    		 Anacetrapib 25 mg Anacetrapib 100 mg Placebo
    Number of subjects analysed
    147
    153
    153
    Units: Percentage of Participants
        number (not applicable)
    15.6
    15.7
    19.6
    Statistical analysis title
    		 Difference in Percentages Between Groups
    Comparison groups
    Anacetrapib 25 mg v Placebo
    Number of subjects included in analysis
    300
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.369
    Method
    		 Miettinen and Nurminen
    Parameter type
    		 Difference in Percentages
    Point estimate
    -4
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -12.7
         upper limit
    		 4.8
    Statistical analysis title
    		 Difference in Percentages Between Groups
    Comparison groups
    Anacetrapib 100 mg v Placebo
    Number of subjects included in analysis
    306
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.369
    Method
    		 Miettinen and Nurminen
    Parameter type
    		 Difference in Percentages
    Point estimate
    -3.9
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -12.6
         upper limit
    		 4.7
    Statistical analysis title
    		 Difference in Percentages Between Groups
    Comparison groups
    Anacetrapib 25 mg v Anacetrapib 100 mg
    Number of subjects included in analysis
    300
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.992
    Method
    		 Miettinen and Nurminen
    Parameter type
    		 Difference in Percentages
    Point estimate
    0
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -8.4
         upper limit
    		 8.4

    Primary: Percentage of Participants With Sodium Levels > Upper Limit of Normal (ULN) - Treatment Period

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    End point title
    		 Percentage of Participants With Sodium Levels > Upper Limit of Normal (ULN) - Treatment Period
    End point description
    Participants had sodium levels assessed throughout the 24 week treatment period. Participants who had any sodium level that was > the ULN of 145 mEq/L were recorded.
    End point type
    Primary
    End point timeframe
    Up to 24 weeks
    End point values
    		 Anacetrapib 25 mg Anacetrapib 100 mg Placebo
    Number of subjects analysed
    146
    153
    153
    Units: Percentage of Participants
        number (not applicable)
    5.5
    11.8
    15
    Statistical analysis title
    		 Difference in Percentages Between Groups
    Comparison groups
    Anacetrapib 25 mg v Placebo
    Number of subjects included in analysis
    299
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.007
    Method
    		 Miettinen and Nurminen
    Parameter type
    		 Difference in Percentages
    Point estimate
    -9.6
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -16.7
         upper limit
    		 -2.8
    Statistical analysis title
    		 Difference in Percentages Between Groups
    Comparison groups
    Anacetrapib 100 mg v Placebo
    Number of subjects included in analysis
    306
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.402
    Method
    		 Miettinen and Nurminen
    Parameter type
    		 Difference in Percentages
    Point estimate
    -3.3
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -11.1
         upper limit
    		 4.5
    Statistical analysis title
    		 Difference in Percentages Between Groups
    Comparison groups
    Anacetrapib 25 mg v Anacetrapib 100 mg
    Number of subjects included in analysis
    299
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.054
    Method
    		 Miettinen and Nurminen
    Parameter type
    		 Difference in Percentages
    Point estimate
    6.3
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.1
         upper limit
    		 13

    Primary: Percentage of Participants With Chloride Levels > ULN - Treatment Period

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    End point title
    		 Percentage of Participants With Chloride Levels > ULN - Treatment Period
    End point description
    Participants had chloride levels assessed throughout the 24 week treatment period. Participants who had any chloride level that was > the ULN of 110 mEq/L were recorded.
    End point type
    Primary
    End point timeframe
    up to 24 weeks
    End point values
    		 Anacetrapib 25 mg Anacetrapib 100 mg Placebo
    Number of subjects analysed
    146
    153
    153
    Units: Percentage of Participants
        number (not applicable)
    0
    0.7
    0.7
    Statistical analysis title
    		 Difference in Percentages Between Group
    Comparison groups
    Anacetrapib 25 mg v Placebo
    Number of subjects included in analysis
    299
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.329
    Method
    		 Miettinen and Nurminen
    Parameter type
    		 Difference in Percentages
    Point estimate
    0.7
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.9
         upper limit
    		 3.6
    Statistical analysis title
    		 Difference in Percentages Between Groups
    Comparison groups
    Anacetrapib 100 mg v Placebo
    Number of subjects included in analysis
    306
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 > 0.999
    Method
    		 Miettinen and Nurminen
    Parameter type
    		 Difference in Percentages
    Point estimate
    0
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -3
         upper limit
    		 3
    Statistical analysis title
    		 Difference in Percentages Between Groups
    Comparison groups
    Anacetrapib 25 mg v Anacetrapib 100 mg
    Number of subjects included in analysis
    299
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.329
    Method
    		 Miettinen and Nurminen
    Parameter type
    		 Difference in Percentages
    Point estimate
    -0.7
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -3.6
         upper limit
    		 1.9

    Primary: Percentage of Participants With Potassium Levels < Lower limit of Normal (LLN) - Treatment Period

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    End point title
    		 Percentage of Participants With Potassium Levels < Lower limit of Normal (LLN) - Treatment Period
    End point description
    Participants had potassium levels assessed throughout the 24 week treatment period. Participants who had any potassium level that was < the ULN of 3.5 mEq/L were recorded.
    End point type
    Primary
    End point timeframe
    up to 24 weeks
    End point values
    		 Anacetrapib 25 mg Anacetrapib 100 mg Placebo
    Number of subjects analysed
    146
    153
    153
    Units: Percentage of Participants
        number (not applicable)
    1.4
    3.9
    2.6
    Statistical analysis title
    		 Difference in Percentages Between Groups
    Comparison groups
    Anacetrapib 25 mg v Placebo
    Number of subjects included in analysis
    299
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.444
    Method
    		 Miettinen and Nurminen
    Parameter type
    		 Difference in Percentages
    Point estimate
    -1.2
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -5.3
         upper limit
    		 2.5
    Statistical analysis title
    		 Difference in Percentages Between Groups
    Comparison groups
    Anacetrapib 100 mg v Placebo
    Number of subjects included in analysis
    306
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.521
    Method
    		 Miettinen and Nurminen
    Parameter type
    		 Difference in Percentages
    Point estimate
    1.3
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -3.1
         upper limit
    		 6
    Statistical analysis title
    		 Difference in Percentages Between Groups
    Comparison groups
    Anacetrapib 25 mg v Anacetrapib 100 mg
    Number of subjects included in analysis
    299
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.172
    Method
    		 Miettinen and Nurminen
    Parameter type
    		 Difference in Percentages
    Point estimate
    2.6
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.4
         upper limit
    		 7.1

    Primary: Percentage of Participants With Bicarbonate Levels > ULN - Treatment Period

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    End point title
    		 Percentage of Participants With Bicarbonate Levels > ULN - Treatment Period
    End point description
    Participants had bicarbonate levels assessed throughout the 24 week treatment period. Participants who had any bicarbonate level that was > the ULN of 33 mEq/L were recorded.
    End point type
    Primary
    End point timeframe
    up to 24 weeks
    End point values
    		 Anacetrapib 25 mg Anacetrapib 100 mg Placebo
    Number of subjects analysed
    146
    153
    153
    Units: Percentage of Particpants
        number (not applicable)
    0
    0
    0
    Statistical analysis title
    		 Difference in Percentages Between Groups
    Comparison groups
    Anacetrapib 25 mg v Placebo
    Number of subjects included in analysis
    299
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 > 0.999
    Method
    		 Miettinen and Nurminen
    Parameter type
    		 Difference in Percentages
    Point estimate
    0
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -2.5
         upper limit
    		 2.6
    Statistical analysis title
    		 Difference in Percentages Between Groups
    Comparison groups
    Anacetrapib 100 mg v Placebo
    Number of subjects included in analysis
    306
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 > 0.999
    Method
    		 Miettinen and Nurminen
    Parameter type
    		 Difference in Percentages
    Point estimate
    0
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -2.5
         upper limit
    		 2.5
    Statistical analysis title
    		 Difference in Percentages Between Groups
    Comparison groups
    Anacetrapib 25 mg v Anacetrapib 100 mg
    Number of subjects included in analysis
    299
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 > 0.999
    Method
    		 Miettinen and Nurminen
    Parameter type
    		 Difference in Percentages
    Point estimate
    0
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -2.6
         upper limit
    		 2.5

    Primary: Percentage of Participants With Consecutive Elevations in Alanine Aminotransferase (ALT) and/or Aspartate Aminotransferase (AST) of ≥3 X ULN

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    End point title
    		 Percentage of Participants With Consecutive Elevations in Alanine Aminotransferase (ALT) and/or Aspartate Aminotransferase (AST) of ≥3 X ULN
    End point description
    Participants had AST and ALT levels assessed throughout the 24 week treatment period. Participants who had 2 consecutive assessments of either AST or ALT that were 3 x ULN or greater were recorded. The AST UNLs for males and females were 43 U/L and 36 U/L, respectively. The ALT UNLs for males and females were 40 U/L and 33 U/L, respectively.
    End point type
    Primary
    End point timeframe
    up to 24 weeks
    End point values
    		 Anacetrapib 25 mg Anacetrapib 100 mg Placebo
    Number of subjects analysed
    146
    153
    153
    Units: Percentage of Participants
        number (not applicable)
    0
    0
    0.7
    Statistical analysis title
    		 Difference in Percentages Between Groups
    Comparison groups
    Anacetrapib 25 mg v Placebo
    Number of subjects included in analysis
    299
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.329
    Method
    		 Miettinen and Nurminen
    Parameter type
    		 Difference in Percentages
    Point estimate
    -0.7
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -3.6
         upper limit
    		 1.9
    Statistical analysis title
    		 Difference in Percentages Between Groups
    Comparison groups
    Anacetrapib 100 mg v Placebo
    Number of subjects included in analysis
    306
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.317
    Method
    		 Miettinen and Nurminen
    Parameter type
    		 Difference in Percentages
    Point estimate
    -0.7
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -3.6
         upper limit
    		 1.8
    Statistical analysis title
    		 Difference in Percentages Between Groups
    Comparison groups
    Anacetrapib 25 mg v Anacetrapib 100 mg
    Number of subjects included in analysis
    299
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 > 0.999
    Method
    		 Miettinen and Nurminen
    Parameter type
    		 Difference in Percentages
    Point estimate
    0
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -2.6
         upper limit
    		 2.5

    Primary: Percentage of Participants With Creatine Kinase (CK) ≥10 x ULN - Treatment Period

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    End point title
    		 Percentage of Participants With Creatine Kinase (CK) ≥10 x ULN - Treatment Period
    End point description
    Participants had CK assessed throughout the 24 week treatment period. Participants who had any CK level that was ≥10 x ULN were recorded. The UNLs for males and females were 207 U/L and 169 U/L, respectively.
    End point type
    Primary
    End point timeframe
    up to 24 weeks
    End point values
    		 Anacetrapib 25 mg Anacetrapib 100 mg Placebo
    Number of subjects analysed
    146
    153
    153
    Units: Percentage of Participants
        number (not applicable)
    0
    0.7
    0
    Statistical analysis title
    		 Difference in Percentages Between Groups
    Comparison groups
    Anacetrapib 25 mg v Placebo
    Number of subjects included in analysis
    299
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 > 0.999
    Method
    		 Miettinen and Nurminen
    Parameter type
    		 Difference in Percentages
    Point estimate
    0
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -2.5
         upper limit
    		 2.6
    Statistical analysis title
    		 Difference in Percentages Between Groups
    Comparison groups
    Anacetrapib 100 mg v Placebo
    Number of subjects included in analysis
    306
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.317
    Method
    		 Miettinen and Nurminen
    Parameter type
    		 Difference in Percentages
    Point estimate
    0.7
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.8
         upper limit
    		 3.6
    Statistical analysis title
    		 Difference in Percentages Between Groups
    Comparison groups
    Anacetrapib 25 mg v Anacetrapib 100 mg
    Number of subjects included in analysis
    299
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.329
    Method
    		 Miettinen and Nurminen
    Parameter type
    		 Difference in Percentages
    Point estimate
    0.7
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.9
         upper limit
    		 3.6

    Primary: Percentage of Participants With CK ≥10 x ULN With Muscle Symptoms - Treatment Period

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    End point title
    		 Percentage of Participants With CK ≥10 x ULN With Muscle Symptoms - Treatment Period
    End point description
    Participants had CK assessed throughout the 24 week treatment period. Participants who had any CK level that was ≥10 x ULN and had associated muscle spasms present within +/- 7 days were recorded. The UNLs for males and females were 207 U/L and 169 U/L, respectively.
    End point type
    Primary
    End point timeframe
    up to 24 week
    End point values
    		 Anacetrapib 25 mg Anacetrapib 100 mg Placebo
    Number of subjects analysed
    146
    153
    153
    Units: Percentage of Participants
        number (not applicable)
    0
    0
    0
    Statistical analysis title
    		 Difference in Percentages Between Groups
    Comparison groups
    Placebo v Anacetrapib 25 mg
    Number of subjects included in analysis
    299
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 > 0.999
    Method
    		 Miettinen and Nurminen
    Parameter type
    		 Difference in Percentages
    Point estimate
    0
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -2.5
         upper limit
    		 2.6
    Statistical analysis title
    		 Difference in Percentages Between Groups
    Comparison groups
    Anacetrapib 100 mg v Placebo
    Number of subjects included in analysis
    306
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 > 0.999
    Method
    		 Miettinen and Nurminen
    Parameter type
    		 Difference in Percentages
    Point estimate
    0
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -2.5
         upper limit
    		 2.5
    Statistical analysis title
    		 Difference in Percentages Between Groups
    Comparison groups
    Anacetrapib 25 mg v Anacetrapib 100 mg
    Number of subjects included in analysis
    299
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 > 0.999
    Method
    		 Miettinen and Nurminen
    Parameter type
    		 Difference in Percentages
    Point estimate
    0
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -2.6
         upper limit
    		 2.5

    Primary: Percentage of Participants with an Adjudicated Cardiovascular (CV) SAE - Treatment Period

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    End point title
    		 Percentage of Participants with an Adjudicated Cardiovascular (CV) SAE - Treatment Period
    End point description
    An AE or suspected adverse reaction is was considered an SAE if it results 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. Participants that experienced adjudicated SAEs of CV death, Non-fatal stroke, non-fatal myocardial infarction, or unstable angina were recorded.
    End point type
    Primary
    End point timeframe
    up to 24 weeks
    End point values
    		 Anacetrapib 25 mg Anacetrapib 100 mg Placebo
    Number of subjects analysed
    152
    153
    154
    Units: Percentage of Participants
        number (not applicable)
    5.3
    3.3
    1.3
    Statistical analysis title
    		 Difference in Percentages Between Groups
    Comparison groups
    Anacetrapib 25 mg v Placebo
    Number of subjects included in analysis
    306
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.12
    Method
    		 Miettinen and Nurminen
    Parameter type
    		 Difference in Percentages
    Point estimate
    3.3
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1
         upper limit
    		 8.3
    Statistical analysis title
    		 Difference in Percentages Between Groups
    Comparison groups
    Anacetrapib 100 mg v Placebo
    Number of subjects included in analysis
    307
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.469
    Method
    		 Miettinen and Nurminen
    Parameter type
    		 Difference in Percentages
    Point estimate
    1.3
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -2.7
         upper limit
    		 5.7
    Statistical analysis title
    		 Difference in Percentages Between Groups
    Comparison groups
    Anacetrapib 25 mg v Anacetrapib 100 mg
    Number of subjects included in analysis
    305
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.389
    Method
    		 Miettinen and Nurminen
    Parameter type
    		 Difference in Percentages
    Point estimate
    -2
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -7.2
         upper limit
    		 2.9

    Primary: Percentage of Participants Who Died From Any Cause - Treatment Period

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    End point title
    		 Percentage of Participants Who Died From Any Cause - Treatment Period
    End point description
    Participants who died from any cause were recorded. All deaths were adjudicated by an expert committee independent of the Sponsor.
    End point type
    Primary
    End point timeframe
    up to 24 weeks
    End point values
    		 Anacetrapib 25 mg Anacetrapib 100 mg Placebo
    Number of subjects analysed
    152
    153
    154
    Units: Percentage of Participants
        number (not applicable)
    0.7
    0.7
    0
    Statistical analysis title
    		 Difference in Percentages Between Groups
    Comparison groups
    Anacetrapib 25 mg v Placebo
    Number of subjects included in analysis
    306
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.314
    Method
    		 Miettinen and Nurminen
    Parameter type
    		 Difference in Percentages
    Point estimate
    0.7
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.8
         upper limit
    		 3.6
    Statistical analysis title
    		 Difference in Percentages Between Groups
    Comparison groups
    Anacetrapib 100 mg v Placebo
    Number of subjects included in analysis
    307
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.316
    Method
    		 Miettinen and Nurminen
    Parameter type
    		 Difference in Percentages
    Point estimate
    0.7
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.8
         upper limit
    		 3.6
    Statistical analysis title
    		 Miettinen and Nurminen
    Comparison groups
    Anacetrapib 25 mg v Anacetrapib 100 mg
    Number of subjects included in analysis
    305
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.996
    Method
    		 Miettinen and Nurminen
    Parameter type
    		 Difference in Percentages
    Point estimate
    0
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -3
         upper limit
    		 3

    Secondary: Percent Change From Baseline in Non-HDL-C- Treatment Period

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    End point title
    		 Percent Change From Baseline in Non-HDL-C- Treatment Period
    End point description
    Non-HDL-C levels measured at baseline and after 24 weeks of treatment.
    End point type
    Secondary
    End point timeframe
    Baseline and Week 24
    End point values
    		 Anacetrapib 25 mg- Efficacy Population Anacetrapib 100 mg- Efficacy Population Placebo - Efficacy Population
    Number of subjects analysed
    133
    138
    137
    Units: Percentage Change
        least squares mean (confidence interval 95%)
    -18.5 (-23.6 to -13.4)
    -24.5 (-29.4 to -19.6)
    5.7 (0.7 to 10.7)
    Statistical analysis title
    		 Difference in Least Squares Mean Change
    Statistical analysis description
    Between group comparison of percentage change from baseline performed using Constrained Longitudinal Data Analysis (cLDA) model with terms for treatment, time, and the interaction of time by treatment. Analysis population defined as participants who received at least 1 dose of study treatment and had baseline and at least 1 post-randomization observation for the analysis endpoint.
    Comparison groups
    Anacetrapib 25 mg- Efficacy Population v Placebo - Efficacy Population
    Number of subjects included in analysis
    270
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001
    Method
    		 Constrained Longitudinal Data Analysis
    Parameter type
    		 Difference in Least Squares Means
    Point estimate
    -24.2
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -30.6
         upper limit
    		 -17.8
    Statistical analysis title
    		 Difference in Least Squares Mean Change
    Statistical analysis description
    Between group comparison of percentage change from baseline performed using Constrained Longitudinal Data Analysis (cLDA) model with terms for treatment, time, and the interaction of time by treatment. Analysis population defined as participants who received at least 1 dose of study treatment and had baseline and at least 1 post-randomization observation for the analysis endpoint.
    Comparison groups
    Anacetrapib 100 mg- Efficacy Population v Placebo - Efficacy Population
    Number of subjects included in analysis
    275
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001
    Method
    		 Constrained Longitudinal Data Analysis
    Parameter type
    		 Difference in Least Squares Means
    Point estimate
    -30.2
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -36.5
         upper limit
    		 -23.9
    Statistical analysis title
    		 Difference in Least Squares Mean Change
    Comparison groups
    Anacetrapib 25 mg- Efficacy Population v Anacetrapib 100 mg- Efficacy Population
    Number of subjects included in analysis
    271
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.067
    Method
    		 Constrained Longitudinal Data Analysis
    Parameter type
    		 Difference in Least Squares Means
    Point estimate
    -6
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -12.3
         upper limit
    		 0.4

    Secondary: Percent Change From Baseline in Apolipoprotein B (Apo B) - Treatment Period

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    End point title
    		 Percent Change From Baseline in Apolipoprotein B (Apo B) - Treatment Period
    End point description
    Apo B levels measured at baseline and after 24 weeks of treatment
    End point type
    Secondary
    End point timeframe
    up to 24 weeks
    End point values
    		 Anacetrapib 25 mg- Efficacy Population Anacetrapib 100 mg- Efficacy Population Placebo - Efficacy Population
    Number of subjects analysed
    131
    137
    136
    Units: Percentage Change
        least squares mean (confidence interval 95%)
    -16.1 (-20.1 to -12.1)
    -17.1 (-20.9 to -13.2)
    1.8 (-2.1 to 5.7)
    Statistical analysis title
    		 Difference in Least Squares Mean Change
    Statistical analysis description
    Between group comparison of percentage change from baseline performed using Constrained Longitudinal Data Analysis (cLDA) model with terms for treatment, time, and the interaction of time by treatment. Analysis population defined as participants who received at least 1 dose of study treatment and had baseline and at least 1 post-randomization observation for the analysis endpoint.
    Comparison groups
    Anacetrapib 25 mg- Efficacy Population v Placebo - Efficacy Population
    Number of subjects included in analysis
    267
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001
    Method
    		 Constrained Longitudinal Data Analysis
    Parameter type
    		 Difference in Least Squares Means
    Point estimate
    -17.9
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -23.1
         upper limit
    		 -12.7
    Statistical analysis title
    		 Difference in Least Squares Mean Change
    Statistical analysis description
    Between group comparison of percentage change from baseline performed using Constrained Longitudinal Data Analysis (cLDA) model with terms for treatment, time, and the interaction of time by treatment. Analysis population defined as participants who received at least 1 dose of study treatment and had baseline and at least 1 post-randomization observation for the analysis endpoint.
    Comparison groups
    Anacetrapib 100 mg- Efficacy Population v Placebo - Efficacy Population
    Number of subjects included in analysis
    273
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001
    Method
    		 Constrained Longitudinal Data Analysis
    Parameter type
    		 Difference in Least Squares Means
    Point estimate
    -18.8
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -24
         upper limit
    		 -13.7
    Statistical analysis title
    		 Difference in Least Squares Mean Change
    Statistical analysis description
    Between group comparison of percentage change from baseline performed using Constrained Longitudinal Data Analysis (cLDA) model with terms for treatment, time, and the interaction of time by treatment. Analysis population defined as participants who received at least 1 dose of study treatment and had baseline and at least 1 post-randomization observation for the analysis endpoint.
    Comparison groups
    Anacetrapib 25 mg- Efficacy Population v Anacetrapib 100 mg- Efficacy Population
    Number of subjects included in analysis
    268
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.712
    Method
    		 Constrained Longitudinal Data Analysis
    Parameter type
    		 Difference in Least Squares Means
    Point estimate
    -1
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -6.2
         upper limit
    		 4.2

    Secondary: Percent Change From Baseline in Apolipoprotein A1 (Apo-A1) - Treatment Period

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    End point title
    		 Percent Change From Baseline in Apolipoprotein A1 (Apo-A1) - Treatment Period
    End point description
    Apo A-1 levels measured at baseline and after 24 weeks of treatment.
    End point type
    Secondary
    End point timeframe
    up to 24 weeks
    End point values
    		 Anacetrapib 25 mg- Efficacy Population Anacetrapib 100 mg- Efficacy Population Placebo - Efficacy Population
    Number of subjects analysed
    131
    137
    136
    Units: Percentage Change
        least squares mean (confidence interval 95%)
    26.2 (22.4 to 29.9)
    33.2 (29.5 to 36.9)
    3.4 (-0.3 to 7.1)
    Statistical analysis title
    		 Difference in Least Squares Mean Change
    Statistical analysis description
    Between group comparison of percentage change from baseline performed using Constrained Longitudinal Data Analysis (cLDA) model with terms for treatment, time, and the interaction of time by treatment. Analysis population defined as participants who received at least 1 dose of study treatment and had baseline and at least 1 post-randomization observation for the analysis endpoint.
    Comparison groups
    Anacetrapib 25 mg- Efficacy Population v Placebo - Efficacy Population
    Number of subjects included in analysis
    267
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001
    Method
    		 Constrained Longitudinal Data Analysis
    Parameter type
    		 Difference in Least Squares Means
    Point estimate
    22.7
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 17.9
         upper limit
    		 27.6
    Statistical analysis title
    		 Difference in Least Squares Mean Change
    Statistical analysis description
    Between group comparison of percentage change from baseline performed using Constrained Longitudinal Data Analysis (cLDA) model with terms for treatment, time, and the interaction of time by treatment. Analysis population defined as participants who received at least 1 dose of study treatment and had baseline and at least 1 post-randomization observation for the analysis endpoint.
    Comparison groups
    Anacetrapib 100 mg- Efficacy Population v Placebo - Efficacy Population
    Number of subjects included in analysis
    273
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001
    Method
    		 Constrained Longitudinal Data Analysis
    Parameter type
    		 Difference in Least Squares Means
    Point estimate
    29.8
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 25
         upper limit
    		 34.6
    Statistical analysis title
    		 Difference in Least Squares Mean Change
    Statistical analysis description
    Between group comparison of percentage change from baseline performed using Constrained Longitudinal Data Analysis (cLDA) model with terms for treatment, time, and the interaction of time by treatment. Analysis population defined as participants who received at least 1 dose of study treatment and had baseline and at least 1 post-randomization observation for the analysis endpoint.
    Comparison groups
    Anacetrapib 25 mg- Efficacy Population v Anacetrapib 100 mg- Efficacy Population
    Number of subjects included in analysis
    268
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.004
    Method
    		 Constrained Longitudinal Data Analysis
    Parameter type
    		 Difference in Least Squares Means
    Point estimate
    7
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 2.2
         upper limit
    		 11.9

    Secondary: Percent Change From Baseline in Lipoprotein(a) (Lp[a]) - Treatment Period

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    End point title
    		 Percent Change From Baseline in Lipoprotein(a) (Lp[a]) - Treatment Period
    End point description
    Lp(a) levels measured at baseline and after 24 weeks of treatment.
    End point type
    Secondary
    End point timeframe
    up to 24 weeks
    End point values
    		 Anacetrapib 25 mg- Efficacy Population Anacetrapib 100 mg- Efficacy Population Placebo - Efficacy Population
    Number of subjects analysed
    137
    147
    144
    Units: Percentage Change
        least squares mean (confidence interval 95%)
    -19.8 (-26 to -13.7)
    -29.5 (-36 to -23)
    -0.1 (-3.7 to 3.5)
    Statistical analysis title
    		 Difference in Median Change
    Statistical analysis description
    Between group comparison of percent change from baseline performed using Hodges-Lehmann estimate of the median difference between treatments with a corresponding distribution-free CI based on Wilcoxon's rank sum test. Analysis population defined as participants who receive at least 1 dose of study treatment and have baseline and at least 1 post-randomization observation for the analysis endpoint.
    Comparison groups
    Anacetrapib 25 mg- Efficacy Population v Placebo - Efficacy Population
    Number of subjects included in analysis
    281
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001
    Method
    		 Wilcoxon (Mann-Whitney)
    Parameter type
    		 Median difference (final values)
    Point estimate
    -22.8
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -29.4
         upper limit
    		 -16.8
    Statistical analysis title
    		 Difference in Median Change
    Statistical analysis description
    Between group comparison of percent change from baseline performed using Hodges-Lehmann estimate of the median difference between treatments with a corresponding distribution-free CI based on Wilcoxon's rank sum test. Analysis population defined as participants who receive at least 1 dose of study treatment and have baseline and at least 1 post-randomization observation for the analysis endpoint.
    Comparison groups
    Anacetrapib 100 mg- Efficacy Population v Placebo - Efficacy Population
    Number of subjects included in analysis
    291
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001
    Method
    		 Wilcoxon (Mann-Whitney)
    Parameter type
    		 Median difference (final values)
    Point estimate
    -32.6
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -39.2
         upper limit
    		 -26.2
    Statistical analysis title
    		 Difference in Median Change
    Statistical analysis description
    Between group comparison of percent change from baseline performed using Hodges-Lehmann estimate of the median difference between treatments with a corresponding distribution-free CI based on Wilcoxon's rank sum test. Analysis population defined as participants who receive at least 1 dose of study treatment and have baseline and at least 1 post-randomization observation for the analysis endpoint.
    Comparison groups
    Anacetrapib 25 mg- Efficacy Population v Anacetrapib 100 mg- Efficacy Population
    Number of subjects included in analysis
    284
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.012
    Method
    		 Wilcoxon (Mann-Whitney)
    Parameter type
    		 Median difference (final values)
    Point estimate
    -8.6
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -15.3
         upper limit
    		 -1.9

    Secondary: Percent Change From Baseline in High-density Lipoprotein-cholesterol (HDL-C) in Participants with Low HDL-C at LDL-C Goal After 24 Weeks - Treatment Period

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    End point title
    		 Percent Change From Baseline in High-density Lipoprotein-cholesterol (HDL-C) in Participants with Low HDL-C at LDL-C Goal After 24 Weeks - Treatment Period
    End point description
    HDL-C levels measured at baseline and after 24 weeks of treatment among participants who were at their LDL-C goal at baseline (as per their coronary heart disease risk category) with low HDL-C
    End point type
    Secondary
    End point timeframe
    Baseline and Week 24
    End point values
    		 Anacetrapib 25 mg- Efficacy Population Anacetrapib 100 mg- Efficacy Population Placebo - Efficacy Population
    Number of subjects analysed
    29
    23
    23
    Units: Percentage Change
        least squares mean (confidence interval 95%)
    87.5 (70.1 to 105)
    105.3 (85.8 to 124.7)
    10.1 (-8.7 to 28.8)
    Statistical analysis title
    		 Difference in Least Squares Mean Changes
    Statistical analysis description
    Between group comparison of percentage change from baseline performed using Constrained Longitudinal Data Analysis (cLDA) model with terms for treatment, time, and the interaction of time by treatment. Analysis population defined as participants who were at their LDL-C goal at baseline (as per their coronary heart disease risk category) with low HDL-C, received at least 1 dose of study treatment and had baseline and at least 1 post-randomization observation for the analysis endpoint.
    Comparison groups
    Anacetrapib 25 mg- Efficacy Population v Placebo - Efficacy Population
    Number of subjects included in analysis
    52
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001
    Method
    		 Constrained Longitudinal Data Analysis
    Parameter type
    		 Difference in Least Squares Means
    Point estimate
    77.5
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 51.8
         upper limit
    		 103.1
    Statistical analysis title
    		 Difference in Least Squares Mean Changes
    Statistical analysis description
    Between group comparison of percentage change from baseline performed using Constrained Longitudinal Data Analysis (cLDA) model with terms for treatment, time, and the interaction of time by treatment. Analysis population defined as participants who were at their LDL-C goal at baseline (as per their coronary heart disease risk category) with low HDL-C, received at least 1 dose of study treatment and had baseline and at least 1 post-randomization observation for the analysis endpoint.
    Comparison groups
    Anacetrapib 100 mg- Efficacy Population v Placebo - Efficacy Population
    Number of subjects included in analysis
    46
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001
    Method
    		 Constrained Longitudinal Data Analysis
    Parameter type
    		 Difference in Least Squares Means
    Point estimate
    95.2
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 68.2
         upper limit
    		 122.2
    Statistical analysis title
    		 Difference in Least Squares Mean Changes
    Statistical analysis description
    Between group comparison of percentage change from baseline performed using Constrained Longitudinal Data Analysis (cLDA) model with terms for treatment, time, and the interaction of time by treatment. Analysis population defined as participants who were at their LDL-C goal at baseline (as per their coronary heart disease risk category) with low HDL-C, received at least 1 dose of study treatment and had baseline and at least 1 post-randomization observation for the analysis endpoint.
    Comparison groups
    Anacetrapib 25 mg- Efficacy Population v Anacetrapib 100 mg- Efficacy Population
    Number of subjects included in analysis
    52
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.179
    Method
    		 Constrained Longitudinal Data Analysis
    Parameter type
    		 Difference in Least Squares Means
    Point estimate
    17.7
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -8.3
         upper limit
    		 43.8

    Adverse events

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    Adverse events information [1]
    Timeframe for reporting adverse events
    up to 36 weeks
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    17.0
    Reporting groups
    Reporting group title
    Anacetrapib 25 mg
    Reporting group description
    		 Participants who received at least 1 dose of Anacetrapib 25 mg

    Reporting group title
    Placebo
    Reporting group description
    		 Participants who received at least 1 dose of placebo.

    Reporting group title
    Anacetrapib 100 mg
    Reporting group description
    		 Participants who received at least 1 dose of Anacetrapib 100 mg

    Notes
    [1] - There are no non-serious adverse events recorded for these results. It is expected that there will be at least one non-serious adverse event reported.
    Justification: None of the reported non-serious adverse events exceeded the 5% cut-off in any of the treatment arms.
    Serious adverse events
    		 Anacetrapib 25 mg Placebo Anacetrapib 100 mg
    Total subjects affected by serious adverse events
         subjects affected / exposed
    8 / 152 (5.26%)
    8 / 154 (5.19%)
    7 / 153 (4.58%)
         number of deaths (all causes)
    1
    0
    1
         number of deaths resulting from adverse events
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Lung cancer metastatic
         subjects affected / exposed
    0 / 152 (0.00%)
    0 / 154 (0.00%)
    1 / 153 (0.65%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    Vascular disorders
    Aortic stenosis
         subjects affected / exposed
    1 / 152 (0.66%)
    0 / 154 (0.00%)
    0 / 153 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Hypotension
         subjects affected / exposed
    1 / 152 (0.66%)
    0 / 154 (0.00%)
    0 / 153 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Intermittent claudication
         subjects affected / exposed
    1 / 152 (0.66%)
    0 / 154 (0.00%)
    0 / 153 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Peripheral embolism
         subjects affected / exposed
    0 / 152 (0.00%)
    0 / 154 (0.00%)
    1 / 153 (0.65%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Peripheral ischaemia
         subjects affected / exposed
    0 / 152 (0.00%)
    0 / 154 (0.00%)
    1 / 153 (0.65%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Cardiac disorders
    Acute coronary syndrome
         subjects affected / exposed
    0 / 152 (0.00%)
    0 / 154 (0.00%)
    1 / 153 (0.65%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Angina unstable
         subjects affected / exposed
    2 / 152 (1.32%)
    0 / 154 (0.00%)
    0 / 153 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Atrial fibrillation
         subjects affected / exposed
    0 / 152 (0.00%)
    0 / 154 (0.00%)
    2 / 153 (1.31%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Coronary artery disease
         subjects affected / exposed
    0 / 152 (0.00%)
    0 / 154 (0.00%)
    1 / 153 (0.65%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Myocardial ischaemia
         subjects affected / exposed
    1 / 152 (0.66%)
    0 / 154 (0.00%)
    0 / 153 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Supraventricular tachycardia
         subjects affected / exposed
    0 / 152 (0.00%)
    0 / 154 (0.00%)
    1 / 153 (0.65%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Nervous system disorders
    Cerebrovascular accident
         subjects affected / exposed
    0 / 152 (0.00%)
    1 / 154 (0.65%)
    0 / 153 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Ischaemic stroke
         subjects affected / exposed
    0 / 152 (0.00%)
    1 / 154 (0.65%)
    0 / 153 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Syncope
         subjects affected / exposed
    1 / 152 (0.66%)
    0 / 154 (0.00%)
    0 / 153 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Coronary artery restenosis
         subjects affected / exposed
    1 / 152 (0.66%)
    0 / 154 (0.00%)
    0 / 153 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Immune system disorders
    Hypersensitivity
         subjects affected / exposed
    0 / 152 (0.00%)
    1 / 154 (0.65%)
    0 / 153 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Acute pulmonary oedema
         subjects affected / exposed
    0 / 152 (0.00%)
    1 / 154 (0.65%)
    0 / 153 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Acute respiratory failure
         subjects affected / exposed
    0 / 152 (0.00%)
    1 / 154 (0.65%)
    0 / 153 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pneumonia aspiration
         subjects affected / exposed
    0 / 152 (0.00%)
    1 / 154 (0.65%)
    0 / 153 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Renal and urinary disorders
    Renal failure acute
         subjects affected / exposed
    1 / 152 (0.66%)
    1 / 154 (0.65%)
    0 / 153 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Osteoarthritis
         subjects affected / exposed
    0 / 152 (0.00%)
    0 / 154 (0.00%)
    1 / 153 (0.65%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    Abscess limb
         subjects affected / exposed
    0 / 152 (0.00%)
    0 / 154 (0.00%)
    1 / 153 (0.65%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Bronchitis
         subjects affected / exposed
    0 / 152 (0.00%)
    1 / 154 (0.65%)
    0 / 153 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Cellulitis
         subjects affected / exposed
    0 / 152 (0.00%)
    1 / 154 (0.65%)
    1 / 153 (0.65%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Gastroenteritis
         subjects affected / exposed
    0 / 152 (0.00%)
    1 / 154 (0.65%)
    0 / 153 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pneumonia
         subjects affected / exposed
    1 / 152 (0.66%)
    0 / 154 (0.00%)
    0 / 153 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    Pneumonia bacterial
         subjects affected / exposed
    0 / 152 (0.00%)
    1 / 154 (0.65%)
    0 / 153 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Metabolism and nutrition disorders
    Hyperglycaemia
         subjects affected / exposed
    1 / 152 (0.66%)
    0 / 154 (0.00%)
    0 / 153 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Anacetrapib 25 mg Placebo Anacetrapib 100 mg
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    0 / 152 (0.00%)
    0 / 154 (0.00%)
    0 / 153 (0.00%)

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    14 Jan 2013
    Provided new data on the pharmacokinetic properties of anacetrapib and related changes to eligibility criteria and study procedures. Most notably, removed women of child-bearing potential from Inclusion Criteria and removed Inclusion Criteria regarding pregnancy and breast-feeding.

    Interruptions (globally)
    Were there any global interruptions to the trial? No

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    None reported
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