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    Clinical Trial Results:
    A Phase 3 Double-blind,Randomized, Placebo-Controlled,Parallel-Group Study to Assess The Efficacy, Safety and Tolerability of PF-04950615 in Subjects With Primary Hyperlipidemia or Mixed Dyslipidemia at Risk of Cardiovascular Events

    Summary
    EudraCT number
    2013-002642-37
    Trial protocol
    CZ   DE   IT   PL  
    Global end of trial date
    05 Apr 2016

    Results information
    Results version number
    v1(current)
    This version publication date
    22 Apr 2017
    First version publication date
    22 Apr 2017
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    B1481019
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    NCT01968954
    WHO universal trial number (UTN)
    -
    Sponsors
    Sponsor organisation name
    Pfizer, Inc.
    Sponsor organisation address
    235 E 42nd Street, New York, United States, NY 10017
    Public contact
    Pfizer ClinicalTrials.gov Call Center, Pfizer, Inc., 001 8007181021, ClinicalTrials.gov_Inquiries@pfizer.com
    Scientific contact
    Pfizer ClinicalTrials.gov Call Center, Pfizer, Inc., 001 8007181021, ClinicalTrials.gov_Inquiries@pfizer.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
    08 Feb 2017
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    05 Apr 2016
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To demonstrate a superior low-density lipoprotein-cholesterol (LDL-C) lowering effect of PF-04950615 150 milligram (mg) administered by the subcutaneous (SC) route every 2 weeks compared to placebo, in subjects with primary hyperlipidemia or mixed dyslipidemia at high and very high risk for cardiovascular events receiving a maximally tolerated dose of statin therapy and whose LDL-C was greater than or equal to (>=) 70 milligram per deciliter (mg/dL) (1.81 millimoles per liter [mmol/L]).
    Protection of trial subjects
    The study was in compliance with the ethical principles derived from the Declaration of Helsinki and in compliance with all International Council for Harmonization (ICH) Good Clinical Practice (GCP) Guidelines. All the local regulatory requirements pertinent to safety of trial subjects were followed.
    Background therapy
    -
    Evidence for comparator
    -
    Actual start date of recruitment
    23 Oct 2013
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Australia: 18
    Country: Number of subjects enrolled
    Canada: 39
    Country: Number of subjects enrolled
    Czech Republic: 7
    Country: Number of subjects enrolled
    Germany: 30
    Country: Number of subjects enrolled
    Hong Kong: 6
    Country: Number of subjects enrolled
    Italy: 27
    Country: Number of subjects enrolled
    Korea, Republic of: 68
    Country: Number of subjects enrolled
    Poland: 95
    Country: Number of subjects enrolled
    United States: 421
    Worldwide total number of subjects
    711
    EEA total number of subjects
    159
    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)
    413
    From 65 to 84 years
    297
    85 years and over
    1

    Subject disposition

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    Recruitment
    Recruitment details
    -

    Pre-assignment
    Screening details
    This study was conducted from 23 October 2013 to 05 April 2016 in Australia, Canada, Czech Republic, Germany, Hong Kong, Italy, Korea, Republic of, Poland and United States.

    Period 1
    Period 1 title
    Overall Study (overall period)
    Is this the baseline period?
    Yes
    Allocation method
    Randomised - controlled
    Blinding used
    Double blind
    Roles blinded
    Subject, Investigator, Carer, Assessor

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    Placebo
    Arm description
    Subjects received single dose of placebo matched to PF-04950615 subcutaneous injection once in every 2 weeks over a period of 52 weeks. Subjects were followed up to 58 weeks.
    Arm type
    Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Subjects received single dose of placebo matched to PF-04950615 subcutaneous injection once in every 2 weeks over a period of 52 weeks.

    Arm title
    PF-04950615 150 mg
    Arm description
    Subjects received single dose of PF-04950615 150 mg subcutaneous injection once in every 2 weeks over a period of 52 weeks. Subjects were followed up to 58 weeks.
    Arm type
    Experimental

    Investigational medicinal product name
    PF-04950615
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Subjects received single dose of PF-04950615 150 mg subcutaneous injection once in every 2 weeks over a period of 52 weeks.

    Number of subjects in period 1
    Placebo PF-04950615 150 mg
    Started
    354
    357
    Treated
    353
    356
    Completed
    314
    314
    Not completed
    40
    43
         Protocol deviation
    -
    1
         Did not meet inclusion criteria
    -
    2
         Unspecified
    8
    10
         Consent withdrawn by subject
    20
    23
         Adverse Events
    6
    3
         Lost to follow-up
    6
    4

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Placebo
    Reporting group description
    Subjects received single dose of placebo matched to PF-04950615 subcutaneous injection once in every 2 weeks over a period of 52 weeks. Subjects were followed up to 58 weeks.

    Reporting group title
    PF-04950615 150 mg
    Reporting group description
    Subjects received single dose of PF-04950615 150 mg subcutaneous injection once in every 2 weeks over a period of 52 weeks. Subjects were followed up to 58 weeks.

    Reporting group values
    Placebo PF-04950615 150 mg Total
    Number of subjects
    354 357 711
    Age categorical
    Units: Subjects
        In utero
    0 0 0
        Preterm newborn infants (gestational age < 37 wks)
    0 0 0
        Newborns (0-27 days)
    0 0 0
        Infants and toddlers (28 days-23 months)
    0 0 0
        Children (2-11 years)
    0 0 0
        Adolescents (12-17 years)
    0 0 0
        Adults (18-64 years)
    201 212 413
        From 65-84 years
    153 144 297
        85 years and over
    0 1 1
    Age Continuous
    Units: years
        arithmetic mean (standard deviation)
    61.5 ± 9.7 61.1 ± 10.2 -
    Gender, Male/Female
    Units: Subjects
        Female
    130 136 266
        Male
    224 221 445

    End points

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    End points reporting groups
    Reporting group title
    Placebo
    Reporting group description
    Subjects received single dose of placebo matched to PF-04950615 subcutaneous injection once in every 2 weeks over a period of 52 weeks. Subjects were followed up to 58 weeks.

    Reporting group title
    PF-04950615 150 mg
    Reporting group description
    Subjects received single dose of PF-04950615 150 mg subcutaneous injection once in every 2 weeks over a period of 52 weeks. Subjects were followed up to 58 weeks.

    Primary: Percent Change From Baseline in Low Density Lipoprotein Cholesterol (LDL-C) at Week 12

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    End point title
    Percent Change From Baseline in Low Density Lipoprotein Cholesterol (LDL-C) at Week 12
    End point description
    Full analysis set (FAS) included all subjects who were randomized. Here, "number of subjects analyzed" signifies those subjects who were evaluable in this endpoint.
    End point type
    Primary
    End point timeframe
    Baseline, Week 12
    End point values
    Placebo PF-04950615 150 mg
    Number of subjects analysed
    329
    336
    Units: percent change
        arithmetic mean (standard deviation)
    1 ± 20.89
    -55.6 ± 29.17
    Statistical analysis title
    Week 12
    Statistical analysis description
    LS-mean difference, associated 95% confidence intervals and p values were derived from MMRM model with fixed effects for treatment group, visit, treatment group*visit interaction, baseline value, baseline value*visit interaction, geographical region, triglyceride subgroup.
    Comparison groups
    Placebo v PF-04950615 150 mg
    Number of subjects included in analysis
    665
    Analysis specification
    Pre-specified
    Analysis type
    other
    P-value
    < 0.001
    Method
    Mixed Model Repeated Measures (MMRM)
    Parameter type
    Least Square (LS) Mean Difference
    Point estimate
    -57
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -61
         upper limit
    -53.1
    Variability estimate
    Standard error of the mean
    Dispersion value
    2

    Secondary: Percent Change From Baseline in Total Cholesterol (TC) at Week 12, 24 and 52

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    End point title
    Percent Change From Baseline in Total Cholesterol (TC) at Week 12, 24 and 52
    End point description
    FAS included all subjects who were randomized. Here, ‘n’ signifies those subjects who were evaluable at specified time points for each arm.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 12, 24, 52
    End point values
    Placebo PF-04950615 150 mg
    Number of subjects analysed
    354
    357
    Units: percent change
    arithmetic mean (standard deviation)
        Week 12 (n =330, 340)
    1 ± 14.85
    -35.1 ± 19.23
        Week 24 (n =331, 337)
    3.2 ± 19.35
    -31.7 ± 20.47
        Week 52 (n =313, 315)
    1.8 ± 18.5
    -27.3 ± 23.57
    Statistical analysis title
    Week 12
    Statistical analysis description
    LS-mean difference, associated 95% confidence intervals and p values were derived from MMRM model with fixed effects for treatment group, visit, treatment group*visit interaction, baseline value, baseline value*visit interaction, geographical region, triglyceride subgroup.
    Comparison groups
    Placebo v PF-04950615 150 mg
    Number of subjects included in analysis
    711
    Analysis specification
    Pre-specified
    Analysis type
    other
    P-value
    < 0.001
    Method
    MMRM
    Parameter type
    LS mean difference
    Point estimate
    -36.2
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -38.8
         upper limit
    -33.6
    Variability estimate
    Standard error of the mean
    Dispersion value
    1.33
    Statistical analysis title
    Week 24
    Statistical analysis description
    LS-mean difference, associated 95% confidence intervals were derived from MMRM model with fixed effects for treatment group, visit, treatment group*visit interaction, baseline value, baseline value*visit interaction, geographical region, triglyceride subgroup.
    Comparison groups
    Placebo v PF-04950615 150 mg
    Number of subjects included in analysis
    711
    Analysis specification
    Pre-specified
    Analysis type
    other
    Method
    Parameter type
    LS mean difference
    Point estimate
    -34.7
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -37.7
         upper limit
    -31.7
    Variability estimate
    Standard error of the mean
    Dispersion value
    1.52
    Statistical analysis title
    Week 52
    Statistical analysis description
    LS-mean difference, associated 95% confidence intervals were derived from MMRM model with fixed effects for treatment group, visit, treatment group*visit interaction, baseline value, baseline value*visit interaction, geographical region, triglyceride subgroup.
    Comparison groups
    Placebo v PF-04950615 150 mg
    Number of subjects included in analysis
    711
    Analysis specification
    Pre-specified
    Analysis type
    other
    Method
    Parameter type
    LS mean difference
    Point estimate
    -29
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -32.3
         upper limit
    -25.7
    Variability estimate
    Standard error of the mean
    Dispersion value
    1.69

    Secondary: Percent Change From Baseline in Non-High Density Lipoprotein-Cholesterol (Non HDL-C) at Week 12, 24 and 52

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    End point title
    Percent Change From Baseline in Non-High Density Lipoprotein-Cholesterol (Non HDL-C) at Week 12, 24 and 52
    End point description
    FAS included all subjects who were randomized. Here, ‘n’ signifies those subjects who were evaluable at specified time points for each arm.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 12, 24, 52
    End point values
    Placebo PF-04950615 150 mg
    Number of subjects analysed
    354
    357
    Units: percent change
    arithmetic mean (standard deviation)
        Week 12 (n =330, 339)
    1.3 ± 19.53
    -50 ± 26.28
        Week 24 (n =329, 336)
    4.7 ± 27.81
    -46.2 ± 28.52
        Week 52 (n =312, 314)
    2.3 ± 25.22
    -38.9 ± 33.32
    Statistical analysis title
    Week 12
    Statistical analysis description
    LS-mean difference, associated 95% confidence intervals and p values were derived from MMRM model with fixed effects for treatment group, visit, treatment group*visit interaction, baseline value, baseline value*visit interaction, geographical region, triglyceride subgroup.
    Comparison groups
    Placebo v PF-04950615 150 mg
    Number of subjects included in analysis
    711
    Analysis specification
    Pre-specified
    Analysis type
    other
    P-value
    < 0.001
    Method
    MMRM
    Parameter type
    LS mean difference
    Point estimate
    -51.6
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -55.2
         upper limit
    -48.1
    Variability estimate
    Standard error of the mean
    Dispersion value
    1.8
    Statistical analysis title
    Week 52
    Statistical analysis description
    LS-mean difference, associated 95% confidence intervals were derived from MMRM model with fixed effects for treatment group, visit, treatment group*visit interaction, baseline value, baseline value*visit interaction, geographical region, triglyceride subgroup.
    Comparison groups
    Placebo v PF-04950615 150 mg
    Number of subjects included in analysis
    711
    Analysis specification
    Pre-specified
    Analysis type
    other
    Method
    Parameter type
    LS mean difference
    Point estimate
    -41.2
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -45.8
         upper limit
    -36.5
    Variability estimate
    Standard error of the mean
    Dispersion value
    2.38
    Statistical analysis title
    Week 24
    Statistical analysis description
    LS-mean difference, associated 95% confidence intervals were derived from MMRM model with fixed effects for treatment group, visit, treatment group*visit interaction, baseline value, baseline value*visit interaction, geographical region, triglyceride subgroup.
    Comparison groups
    Placebo v PF-04950615 150 mg
    Number of subjects included in analysis
    711
    Analysis specification
    Pre-specified
    Analysis type
    other
    Method
    Parameter type
    LS mean difference
    Point estimate
    -50.6
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -54.9
         upper limit
    -46.4
    Variability estimate
    Standard error of the mean
    Dispersion value
    2.15

    Secondary: Percent Change From Baseline in Apolipoprotein B (ApoB) at Week 12, 24 and 52

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    End point title
    Percent Change From Baseline in Apolipoprotein B (ApoB) at Week 12, 24 and 52
    End point description
    FAS included all subjects who were randomized. Here, ‘n’ signifies those subjects who were evaluable at specified time points for each arm.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 12, 24, 52
    End point values
    Placebo PF-04950615 150 mg
    Number of subjects analysed
    354
    357
    Units: percent change
    arithmetic mean (standard deviation)
        Week 12 (n =330, 339)
    0.3 ± 19.1
    -51.1 ± 27.62
        Week 24 (n =331, 335)
    3.5 ± 22.39
    -47.3 ± 30.43
        Week 52 (n =313, 313)
    1.9 ± 22.25
    -39.1 ± 33.39
    Statistical analysis title
    Week 12
    Statistical analysis description
    LS-mean difference, associated 95% confidence intervals and p values were derived from MMRM model with fixed effects for treatment group, visit, treatment group*visit interaction, baseline value, baseline value*visit interaction, geographical region, triglyceride subgroup.
    Comparison groups
    Placebo v PF-04950615 150 mg
    Number of subjects included in analysis
    711
    Analysis specification
    Pre-specified
    Analysis type
    other
    P-value
    < 0.001
    Method
    MMRM
    Parameter type
    LS mean difference
    Point estimate
    -51.5
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -55.1
         upper limit
    -47.9
    Variability estimate
    Standard error of the mean
    Dispersion value
    1.84
    Statistical analysis title
    Week 24
    Statistical analysis description
    LS-mean difference, associated 95% confidence intervals were derived from MMRM model with fixed effects for treatment group, visit, treatment group*visit interaction, baseline value, baseline value*visit interaction, geographical region, triglyceride subgroup.
    Comparison groups
    Placebo v PF-04950615 150 mg
    Number of subjects included in analysis
    711
    Analysis specification
    Pre-specified
    Analysis type
    other
    Method
    Parameter type
    LS mean difference
    Point estimate
    -50.6
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -54.6
         upper limit
    -46.6
    Variability estimate
    Standard error of the mean
    Dispersion value
    2.05
    Statistical analysis title
    Week 52
    Statistical analysis description
    LS-mean difference, associated 95% confidence intervals were derived from MMRM model with fixed effects for treatment group, visit, treatment group*visit interaction, baseline value, baseline value*visit interaction, geographical region, triglyceride subgroup.
    Comparison groups
    Placebo v PF-04950615 150 mg
    Number of subjects included in analysis
    711
    Analysis specification
    Pre-specified
    Analysis type
    other
    Method
    Parameter type
    LS mean difference
    Point estimate
    -40.8
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -45.2
         upper limit
    -36.3
    Variability estimate
    Standard error of the mean
    Dispersion value
    2.26

    Secondary: Percent Change From Baseline in Lipoprotein(a) at Week 12, 24 and 52

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    End point title
    Percent Change From Baseline in Lipoprotein(a) at Week 12, 24 and 52
    End point description
    FAS included all subjects who were randomized. Here, ‘n’ signifies those subjects who were evaluable at specified time points for each arm.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 12, 24, 52
    End point values
    Placebo PF-04950615 150 mg
    Number of subjects analysed
    354
    357
    Units: percent change
    arithmetic mean (standard deviation)
        Week 12 (n =330, 339)
    4.7 ± 84.86
    1.9 ± 508.44
        Week 24 (n =331, 336)
    1.9 ± 51.82
    4.4 ± 465.24
        Week 52 (n =311, 311)
    1.1 ± 42.47
    17.3 ± 562.63
    Statistical analysis title
    Week 12
    Statistical analysis description
    LS-mean difference, associated 95% confidence intervals and p values were derived from MMRM model with fixed effects for treatment group, visit, treatment group*visit interaction, baseline value, baseline value*visit interaction, geographical region, triglyceride subgroup.
    Comparison groups
    Placebo v PF-04950615 150 mg
    Number of subjects included in analysis
    711
    Analysis specification
    Pre-specified
    Analysis type
    other
    P-value
    = 0.86
    Method
    MMRM
    Parameter type
    LS mean difference
    Point estimate
    -2.9
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -35.4
         upper limit
    29.5
    Variability estimate
    Standard error of the mean
    Dispersion value
    16.55
    Statistical analysis title
    Week 24
    Statistical analysis description
    LS-mean difference, associated 95% confidence intervals were derived from MMRM model with fixed effects for treatment group, visit, treatment group*visit interaction, baseline value, baseline value*visit interaction, geographical region, triglyceride subgroup.
    Comparison groups
    Placebo v PF-04950615 150 mg
    Number of subjects included in analysis
    711
    Analysis specification
    Pre-specified
    Analysis type
    other
    Method
    Parameter type
    LS mean difference
    Point estimate
    2.1
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -47.2
         upper limit
    51.4
    Variability estimate
    Standard error of the mean
    Dispersion value
    25.11
    Statistical analysis title
    Week 52
    Statistical analysis description
    LS-mean difference, associated 95% confidence intervals were derived from MMRM model with fixed effects for treatment group, visit, treatment group*visit interaction, baseline value, baseline value*visit interaction, geographical region, triglyceride subgroup.
    Comparison groups
    Placebo v PF-04950615 150 mg
    Number of subjects included in analysis
    711
    Analysis specification
    Pre-specified
    Analysis type
    other
    Method
    Parameter type
    LS mean difference
    Point estimate
    12.9
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -44.5
         upper limit
    70.4
    Variability estimate
    Standard error of the mean
    Dispersion value
    29.25

    Secondary: Percent Change From Baseline in High Density Lipoprotein Cholesterol (HDL-C) at Week 12, 24 and 52

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    End point title
    Percent Change From Baseline in High Density Lipoprotein Cholesterol (HDL-C) at Week 12, 24 and 52
    End point description
    FAS included all subjects who were randomized. Here, ‘n’ signifies those subjects who were evaluable at specified time points for each arm.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 12, 24, 52
    End point values
    Placebo PF-04950615 150 mg
    Number of subjects analysed
    354
    357
    Units: percent change
    arithmetic mean (standard deviation)
        Week 12 (n= 330, 339)
    1.9 ± 17.24
    6.6 ± 14.24
        Week 24 (n =329, 336)
    1 ± 15.78
    7.8 ± 15.91
        Week 52 (n =312, 314)
    2 ± 15.73
    5.3 ± 16.59
    Statistical analysis title
    Week 12
    Statistical analysis description
    LS-mean difference, associated 95% confidence intervals and p values were derived from MMRM model with fixed effects for treatment group, visit, treatment group*visit interaction, baseline value, baseline value*visit interaction, geographical region, triglyceride subgroup.
    Comparison groups
    Placebo v PF-04950615 150 mg
    Number of subjects included in analysis
    711
    Analysis specification
    Pre-specified
    Analysis type
    other
    P-value
    < 0.001
    Method
    MMRM
    Parameter type
    LS mean difference
    Point estimate
    4.7
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    2.4
         upper limit
    7
    Variability estimate
    Standard error of the mean
    Dispersion value
    1.19
    Statistical analysis title
    Week 24
    Statistical analysis description
    LS-mean difference, associated 95% confidence intervals were derived from MMRM model with fixed effects for treatment group, visit, treatment group*visit interaction, baseline value, baseline value*visit interaction, geographical region, triglyceride subgroup.
    Comparison groups
    Placebo v PF-04950615 150 mg
    Number of subjects included in analysis
    711
    Analysis specification
    Pre-specified
    Analysis type
    other
    Method
    Parameter type
    LS mean difference
    Point estimate
    6.8
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    4.5
         upper limit
    9.1
    Variability estimate
    Standard error of the mean
    Dispersion value
    1.18
    Statistical analysis title
    Week 52
    Statistical analysis description
    LS-mean difference, associated 95% confidence intervals were derived from MMRM model with fixed effects for treatment group, visit, treatment group*visit interaction, baseline value, baseline value*visit interaction, geographical region, triglyceride subgroup.
    Comparison groups
    Placebo v PF-04950615 150 mg
    Number of subjects included in analysis
    711
    Analysis specification
    Pre-specified
    Analysis type
    other
    Method
    Parameter type
    LS mean difference
    Point estimate
    3.3
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    0.9
         upper limit
    5.8
    Variability estimate
    Standard error of the mean
    Dispersion value
    1.25

    Secondary: Percent Change From Baseline in Fasting Low-Density Lipoprotein-Cholesterol (LDL-C) at Week 12 in Subjects With Primary Hyperlipidemia

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    End point title
    Percent Change From Baseline in Fasting Low-Density Lipoprotein-Cholesterol (LDL-C) at Week 12 in Subjects With Primary Hyperlipidemia
    End point description
    Subjects with primary hyperlipidemia was defined as subjects with triglycerides (TG) level less than (<) 200 mg/dL (2.26 mmol/L) at pre-randomization. FAS included all subjects who were randomized. Here, "number of subjects analyzed" signifies those subjects who were evaluable in this endpoint.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 12
    End point values
    Placebo PF-04950615 150 mg
    Number of subjects analysed
    262
    266
    Units: percent change
        arithmetic mean (standard deviation)
    1.5 ± 20.89
    -56.8 ± 27.78
    Statistical analysis title
    Week 12
    Statistical analysis description
    LS-mean difference, associated 95% confidence intervals and p values were derived from MMRM model with fixed effects for treatment group, visit, treatment group*visit interaction, baseline value, baseline value*visit interaction, geographical region.
    Comparison groups
    Placebo v PF-04950615 150 mg
    Number of subjects included in analysis
    528
    Analysis specification
    Pre-specified
    Analysis type
    other
    P-value
    < 0.001
    Method
    MMRM
    Parameter type
    LS mean difference
    Point estimate
    -59.1
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -63.4
         upper limit
    -54.8
    Variability estimate
    Standard error of the mean
    Dispersion value
    2.19

    Secondary: Percent Change From Baseline in Fasting Low-Density Lipoprotein-Cholesterol (LDL-C) at Week 12 in Subjects With Mixed Dyslipidemia

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    End point title
    Percent Change From Baseline in Fasting Low-Density Lipoprotein-Cholesterol (LDL-C) at Week 12 in Subjects With Mixed Dyslipidemia
    End point description
    Subjects with mixed dyslipidemia were defined as TG level >=200 mg/dL (2.26 mmol/L) at pre-randomization. FAS included all subjects who were randomized. Here, "number of subjects analyzed" signifies those subjects who were evaluable in this endpoint.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 12
    End point values
    Placebo PF-04950615 150 mg
    Number of subjects analysed
    67
    70
    Units: percent change
        arithmetic mean (standard deviation)
    -1 ± 20.95
    -50.9 ± 33.78
    Statistical analysis title
    Week 12
    Statistical analysis description
    LS-mean difference, associated 95% confidence intervals and p values were derived from MMRM model with fixed effects for treatment group, visit, treatment group*visit interaction, baseline value, baseline value*visit interaction, geographical region.
    Comparison groups
    Placebo v PF-04950615 150 mg
    Number of subjects included in analysis
    137
    Analysis specification
    Pre-specified
    Analysis type
    other
    P-value
    < 0.001
    Method
    MMRM
    Parameter type
    LS mean difference
    Point estimate
    -48.7
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -58
         upper limit
    -39.3
    Variability estimate
    Standard error of the mean
    Dispersion value
    4.72

    Secondary: Percent Change From Baseline in Fasting Low Density Lipoprotein-Cholesterol (LDL-C) at Week 24 and 52

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    End point title
    Percent Change From Baseline in Fasting Low Density Lipoprotein-Cholesterol (LDL-C) at Week 24 and 52
    End point description
    FAS included all subjects who were randomized. Here, ‘n’ signifies those subjects who were evaluable at specified time points for each arm.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 24, 52
    End point values
    Placebo PF-04950615 150 mg
    Number of subjects analysed
    354
    357
    Units: percent change
    arithmetic mean (standard deviation)
        Week 24 (n =331, 336)
    6.3 ± 32.52
    -50 ± 31.36
        Week 52 (n =311, 313)
    5.2 ± 29.69
    -40.9 ± 38.02
    Statistical analysis title
    Week 24
    Statistical analysis description
    LS-mean difference, associated 95% confidence intervals were derived from MMRM model with fixed effects for treatment group, visit, treatment group*visit interaction, baseline value, baseline value*visit interaction, geographical region, triglyceride subgroup.
    Comparison groups
    Placebo v PF-04950615 150 mg
    Number of subjects included in analysis
    711
    Analysis specification
    Pre-specified
    Analysis type
    other
    Method
    Parameter type
    LS mean difference
    Point estimate
    -56
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -60.8
         upper limit
    -51.2
    Variability estimate
    Standard error of the mean
    Dispersion value
    2.45
    Statistical analysis title
    Week 52
    Statistical analysis description
    LS-mean difference, associated 95% confidence intervals were derived from MMRM model with fixed effects for treatment group, visit, treatment group*visit interaction, baseline value, baseline value*visit interaction, geographical region, triglyceride subgroup.
    Comparison groups
    Placebo v PF-04950615 150 mg
    Number of subjects included in analysis
    711
    Analysis specification
    Pre-specified
    Analysis type
    other
    Method
    Parameter type
    LS mean difference
    Point estimate
    -46.4
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -51.8
         upper limit
    -41
    Variability estimate
    Standard error of the mean
    Dispersion value
    2.77

    Secondary: Percent Change From Baseline in Fasting Low Density Lipoprotein Cholesterol (LDL-C) at Week 24 and 52 by Triglyceride Cut-off

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    End point title
    Percent Change From Baseline in Fasting Low Density Lipoprotein Cholesterol (LDL-C) at Week 24 and 52 by Triglyceride Cut-off
    End point description
    Percent change from baseline in fasting LDL-C among subjects with TG cut-off of <200 mg/dL and >=200 mg/dL (2.26 mmol/L) were reported in this endpoint. FAS included all subjects who were randomized. Here, ‘n’ signifies those subjects who were evaluable at specified time point for each arm.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 24, 52
    End point values
    Placebo PF-04950615 150 mg
    Number of subjects analysed
    354
    357
    Units: percent change
    arithmetic mean (standard deviation)
        TG <200 mg/dL: Week 24 (n =261, 265)
    7.2 ± 34.38
    -50.8 ± 30.9
        TG <200 mg/dL: Week 52(n =243, 248)
    6.2 ± 29.95
    -41.1 ± 38.35
        TG >=200 mg/dL: Week 24(n =70, 71)
    3 ± 24.3
    -46.9 ± 33.05
        TG >=200 mg/dL: Week 52(n =68, 65)
    2 ± 28.74
    -40.1 ± 37.01
    Statistical analysis title
    TG <200 mg/dL: Week 24
    Statistical analysis description
    LS-mean difference, associated 95% confidence intervals were derived from MMRM model with fixed effects for treatment group, visit, treatment group*visit interaction, baseline value, baseline value*visit interaction, geographical region.
    Comparison groups
    Placebo v PF-04950615 150 mg
    Number of subjects included in analysis
    711
    Analysis specification
    Pre-specified
    Analysis type
    other
    Method
    Parameter type
    LS mean difference
    Point estimate
    -57.6
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -63.1
         upper limit
    -52
    Variability estimate
    Standard error of the mean
    Dispersion value
    2.82
    Statistical analysis title
    TG <200 mg/dL: Week 52
    Statistical analysis description
    LS-mean difference, associated 95% confidence intervals were derived from MMRM model with fixed effects for treatment group, visit, treatment group*visit interaction, baseline value, baseline value*visit interaction, geographical region.
    Comparison groups
    Placebo v PF-04950615 150 mg
    Number of subjects included in analysis
    711
    Analysis specification
    Pre-specified
    Analysis type
    other
    Method
    Parameter type
    LS mean difference
    Point estimate
    -47.7
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -53.9
         upper limit
    -41.5
    Variability estimate
    Standard error of the mean
    Dispersion value
    3.16
    Statistical analysis title
    TG >=200 mg/dL: Week 24
    Statistical analysis description
    LS-mean difference, associated 95% confidence intervals were derived from MMRM model with fixed effects for treatment group, visit, treatment group*visit interaction, baseline value, baseline value*visit interaction, geographical region.
    Comparison groups
    Placebo v PF-04950615 150 mg
    Number of subjects included in analysis
    711
    Analysis specification
    Pre-specified
    Analysis type
    other
    Method
    Parameter type
    LS mean difference
    Point estimate
    -49.3
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -58.9
         upper limit
    -39.8
    Variability estimate
    Standard error of the mean
    Dispersion value
    4.83
    Statistical analysis title
    TG >=200 mg/dL: Week 52
    Statistical analysis description
    LS-mean difference, associated 95% confidence intervals were derived from MMRM model with fixed effects for treatment group, visit, treatment group*visit interaction, baseline value, baseline value*visit interaction, geographical region.
    Comparison groups
    Placebo v PF-04950615 150 mg
    Number of subjects included in analysis
    711
    Analysis specification
    Pre-specified
    Analysis type
    other
    Method
    Parameter type
    LS mean difference
    Point estimate
    -41.2
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -52.2
         upper limit
    -30.1
    Variability estimate
    Standard error of the mean
    Dispersion value
    5.6

    Secondary: Percent Change From Baseline in Fasting Triglyceride (TG) at Week 12, 24 and 52

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    End point title
    Percent Change From Baseline in Fasting Triglyceride (TG) at Week 12, 24 and 52
    End point description
    FAS included all subjects who were randomized. Here, ‘n’ signifies those subjects who were evaluable at specified time points for each arm.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 12, 24, 52
    End point values
    Placebo PF-04950615 150 mg
    Number of subjects analysed
    354
    357
    Units: percent change
    arithmetic mean (standard deviation)
        Week 12 (n =330, 340)
    5.9 ± 34.9
    -9.4 ± 42
        Week 24 (n =331, 336)
    7 ± 37.79
    -13.8 ± 33.24
        Week 52 (n =313, 315)
    0.6 ± 38.33
    -9.3 ± 48.47
    Statistical analysis title
    Week 12
    Statistical analysis description
    LS-mean difference, associated 95% confidence intervals were derived from MMRM model with fixed effects for treatment group, visit, treatment group*visit interaction, baseline value, baseline value*visit interaction, geographical region, triglyceride subgroup.
    Comparison groups
    Placebo v PF-04950615 150 mg
    Number of subjects included in analysis
    711
    Analysis specification
    Pre-specified
    Analysis type
    other
    Method
    Parameter type
    LS mean difference
    Point estimate
    -14.2
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -19.9
         upper limit
    -8.5
    Variability estimate
    Standard error of the mean
    Dispersion value
    2.88
    Statistical analysis title
    Week 24
    Statistical analysis description
    LS-mean difference, associated 95% confidence intervals were derived from MMRM model with fixed effects for treatment group, visit, treatment group*visit interaction, baseline value, baseline value*visit interaction, geographical region, triglyceride subgroup.
    Comparison groups
    Placebo v PF-04950615 150 mg
    Number of subjects included in analysis
    711
    Analysis specification
    Pre-specified
    Analysis type
    other
    Method
    Parameter type
    LS mean difference
    Point estimate
    -19.9
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -25.1
         upper limit
    -14.7
    Variability estimate
    Standard error of the mean
    Dispersion value
    2.65
    Statistical analysis title
    Week 52
    Statistical analysis description
    LS-mean difference, associated 95% confidence intervals were derived from MMRM model with fixed effects for treatment group, visit, treatment group*visit interaction, baseline value, baseline value*visit interaction, geographical region, triglyceride subgroup.
    Comparison groups
    Placebo v PF-04950615 150 mg
    Number of subjects included in analysis
    711
    Analysis specification
    Pre-specified
    Analysis type
    other
    Method
    Parameter type
    LS mean difference
    Point estimate
    -9.2
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -15.7
         upper limit
    -2.8
    Variability estimate
    Standard error of the mean
    Dispersion value
    3.31

    Secondary: Percent Change From Baseline in ApolipoproteinA-I (ApoA-I) at Week 12, 24 and 52

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    End point title
    Percent Change From Baseline in ApolipoproteinA-I (ApoA-I) at Week 12, 24 and 52
    End point description
    FAS included all subjects who were randomized. Here, ‘n’ signifies those subjects who were evaluable at specified time points for each arm.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 12, 24, 52
    End point values
    Placebo PF-04950615 150 mg
    Number of subjects analysed
    354
    357
    Units: percent change
    arithmetic mean (standard deviation)
        Week 12 (n =330, 339)
    -0.3 ± 14.05
    3.7 ± 12.56
        Week 24 (n =331, 336)
    -0.8 ± 12.77
    4.3 ± 12.25
        Week 52 (n =313, 313)
    0.4 ± 13.13
    3.3 ± 13
    Statistical analysis title
    Week 12
    Statistical analysis description
    LS-mean difference, associated 95% confidence intervals were derived from MMRM model with fixed effects for treatment group, visit, treatment group*visit interaction, baseline value, baseline value*visit interaction, geographical region, triglyceride subgroup.
    Comparison groups
    Placebo v PF-04950615 150 mg
    Number of subjects included in analysis
    711
    Analysis specification
    Pre-specified
    Analysis type
    other
    Method
    Parameter type
    LS mean difference
    Point estimate
    3.7
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    1.8
         upper limit
    5.7
    Variability estimate
    Standard error of the mean
    Dispersion value
    1
    Statistical analysis title
    Week 24
    Statistical analysis description
    LS-mean difference, associated 95% confidence intervals were derived from MMRM model with fixed effects for treatment group, visit, treatment group*visit interaction, baseline value, baseline value*visit interaction, geographical region, triglyceride subgroup.
    Comparison groups
    Placebo v PF-04950615 150 mg
    Number of subjects included in analysis
    711
    Analysis specification
    Pre-specified
    Analysis type
    other
    Method
    Parameter type
    LS mean difference
    Point estimate
    4.9
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    3.1
         upper limit
    6.7
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.91
    Statistical analysis title
    Week 54
    Statistical analysis description
    LS-mean difference, associated 95% confidence intervals were derived from MMRM model with fixed effects for treatment group, visit, treatment group*visit interaction, baseline value, baseline value*visit interaction, geographical region, triglyceride subgroup.
    Comparison groups
    Placebo v PF-04950615 150 mg
    Number of subjects included in analysis
    711
    Analysis specification
    Pre-specified
    Analysis type
    other
    Method
    Parameter type
    LS mean difference
    Point estimate
    2.6
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    0.7
         upper limit
    4.6
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.98

    Secondary: Percent Change From Baseline in ApolipoproteinA-II (ApoA-II) at Week 12, 24 and 52

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    End point title
    Percent Change From Baseline in ApolipoproteinA-II (ApoA-II) at Week 12, 24 and 52
    End point description
    FAS included all subjects who were randomized. Here, ‘n’ signifies those subjects who were evaluable at specified time points for each arm.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 12, 24, 52
    End point values
    Placebo PF-04950615 150 mg
    Number of subjects analysed
    354
    357
    Units: percent change
    arithmetic mean (standard deviation)
        Week 12 (n =327, 339)
    -1.8 ± 12.92
    -1.9 ± 12.1
        Week 24 (n =331, 335)
    -3.7 ± 14.4
    -1.9 ± 13.25
        Week 52 (n =310, 310)
    -3 ± 14.76
    -1.6 ± 12.91
    Statistical analysis title
    Week 12
    Statistical analysis description
    LS-mean difference, associated 95% confidence intervals were derived from MMRM model with fixed effects for treatment group, visit, treatment group*visit interaction, baseline value, baseline value*visit interaction, geographical region, triglyceride subgroup.
    Comparison groups
    Placebo v PF-04950615 150 mg
    Number of subjects included in analysis
    711
    Analysis specification
    Pre-specified
    Analysis type
    other
    Method
    Parameter type
    LS mean difference
    Point estimate
    -0.1
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -1.9
         upper limit
    1.7
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.93
    Statistical analysis title
    Week 24
    Statistical analysis description
    LS-mean difference, associated 95% confidence intervals were derived from MMRM model with fixed effects for treatment group, visit, treatment group*visit interaction, baseline value, baseline value*visit interaction, geographical region, triglyceride subgroup.
    Comparison groups
    Placebo v PF-04950615 150 mg
    Number of subjects included in analysis
    711
    Analysis specification
    Pre-specified
    Analysis type
    other
    Method
    Parameter type
    LS mean difference
    Point estimate
    1.9
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -0.1
         upper limit
    3.9
    Variability estimate
    Standard error of the mean
    Dispersion value
    1.02
    Statistical analysis title
    Week 52
    Statistical analysis description
    LS-mean difference, associated 95% confidence intervals were derived from MMRM model with fixed effects for treatment group, visit, treatment group*visit interaction, baseline value, baseline value*visit interaction, geographical region, triglyceride subgroup.
    Comparison groups
    Placebo v PF-04950615 150 mg
    Number of subjects included in analysis
    711
    Analysis specification
    Pre-specified
    Analysis type
    other
    Method
    Parameter type
    LS mean difference
    Point estimate
    1
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -1
         upper limit
    3.1
    Variability estimate
    Standard error of the mean
    Dispersion value
    1.03

    Secondary: Percent Change From Baseline in Very Low Density Lipoprotein-Cholesterol (VLDL-C) at Week 12, 24 and 52

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    End point title
    Percent Change From Baseline in Very Low Density Lipoprotein-Cholesterol (VLDL-C) at Week 12, 24 and 52
    End point description
    FAS included all subjects who were randomized. Here, ‘n’ signifies those subjects who were evaluable at specified time points for each arm.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 12, 24, 52
    End point values
    Placebo PF-04950615 150 mg
    Number of subjects analysed
    354
    357
    Units: percent change
    arithmetic mean (standard deviation)
        Week 12 (n =330, 340)
    5.9 ± 34.9
    -9.4 ± 42
        Week 24 (n =331, 336)
    7 ± 37.79
    -13.8 ± 33.24
        Week 52 (n =313, 315)
    0.6 ± 38.33
    -9.3 ± 48.47
    Statistical analysis title
    Week 12
    Statistical analysis description
    LS-mean difference, associated 95% confidence intervals were derived from MMRM model with fixed effects for treatment group, visit, treatment group*visit interaction, baseline value, baseline value*visit interaction, geographical region, triglyceride subgroup.
    Comparison groups
    Placebo v PF-04950615 150 mg
    Number of subjects included in analysis
    711
    Analysis specification
    Pre-specified
    Analysis type
    other
    Method
    Parameter type
    LS-Mean Difference
    Point estimate
    -14.2
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -19.9
         upper limit
    -8.5
    Variability estimate
    Standard error of the mean
    Dispersion value
    2.88
    Statistical analysis title
    Week 24
    Statistical analysis description
    LS-mean difference, associated 95% confidence intervals were derived from MMRM model with fixed effects for treatment group, visit, treatment group*visit interaction, baseline value, baseline value*visit interaction, geographical region, triglyceride subgroup.
    Comparison groups
    Placebo v PF-04950615 150 mg
    Number of subjects included in analysis
    711
    Analysis specification
    Pre-specified
    Analysis type
    other
    Method
    Parameter type
    LS mean difference
    Point estimate
    -19.9
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -25.1
         upper limit
    -14.7
    Variability estimate
    Standard error of the mean
    Dispersion value
    2.65
    Statistical analysis title
    Week 52
    Statistical analysis description
    LS-mean difference, associated 95% confidence intervals were derived from MMRM model with fixed effects for treatment group, visit, treatment group*visit interaction, baseline value, baseline value*visit interaction, geographical region, triglyceride subgroup.
    Comparison groups
    Placebo v PF-04950615 150 mg
    Number of subjects included in analysis
    711
    Analysis specification
    Pre-specified
    Analysis type
    other
    Method
    Parameter type
    LS mean difference
    Point estimate
    -9.2
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -15.7
         upper limit
    -2.8
    Variability estimate
    Standard error of the mean
    Dispersion value
    3.31

    Secondary: Absolute Change From Baseline in Fasting Low Density Lipoprotein-Cholesterol (LDL-C) at Week 12 by Trigylceride Cut-Off

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    End point title
    Absolute Change From Baseline in Fasting Low Density Lipoprotein-Cholesterol (LDL-C) at Week 12 by Trigylceride Cut-Off
    End point description
    Change from baseline in fasting LDL-C among subjects with TG cut-off of <200 mg/dL and >=200 mg/dL (2.26 mmol/L) were reported in this endpoint. FAS included all subjects who were randomized. Here, ‘number of subjects analyzed’ signifies those subjects who were evaluable in this endpoint and ‘n’ signifies those subjects who were evaluable at specified time points for each arm.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 12
    End point values
    Placebo PF-04950615 150 mg
    Number of subjects analysed
    353
    357
    Units: mg/dL
    arithmetic mean (standard deviation)
        TG <200 mg/dL: Baseline (n =282, 282)
    111.2 ± 31.28
    112.8 ± 36.42
        TG <200 mg/dL: Change at Week12 (n =262, 266)
    0.4 ± 22.6
    -63.4 ± 37.38
        TG >=200 mg/dL: Baseline (n =71, 75)
    126.5 ± 42.07
    125.7 ± 42.1
        TG >=200 mg/dL: Change at Week 12 (n =67, 70)
    -2.6 ± 26.98
    -63.1 ± 44.91
    Statistical analysis title
    TG <200 mg/dL: Week 12
    Statistical analysis description
    LS-mean difference, associated 95% confidence intervals were derived from MMRM model with fixed effects for treatment group, visit, treatment group*visit interaction, baseline value, baseline value*visit interaction, geographical region, triglyceride subgroup.
    Comparison groups
    Placebo v PF-04950615 150 mg
    Number of subjects included in analysis
    710
    Analysis specification
    Pre-specified
    Analysis type
    other
    Method
    Parameter type
    LS mean difference
    Point estimate
    -64.2
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -69.1
         upper limit
    -59.2
    Variability estimate
    Standard error of the mean
    Dispersion value
    2.51
    Statistical analysis title
    TG >=200 mg/dL: Week 12
    Statistical analysis description
    LS-mean difference, associated 95% confidence intervals were derived from MMRM model with fixed effects for treatment group, visit, treatment group*visit interaction, baseline value, baseline value*visit interaction, geographical region, triglyceride subgroup.
    Comparison groups
    Placebo v PF-04950615 150 mg
    Number of subjects included in analysis
    710
    Analysis specification
    Pre-specified
    Analysis type
    other
    Method
    Parameter type
    LS mean difference
    Point estimate
    -59.6
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -71.4
         upper limit
    -47.7
    Variability estimate
    Standard error of the mean
    Dispersion value
    5.99

    Secondary: Absolute Change From Baseline in Fasting Low Density Lipoprotein-Cholesterol (LDL-C) at Week 12, 24 and 52

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    End point title
    Absolute Change From Baseline in Fasting Low Density Lipoprotein-Cholesterol (LDL-C) at Week 12, 24 and 52
    End point description
    FAS included all subjects who were randomized. Here, ‘n’ signifies those subjects who were evaluable at specified time points for each arm.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 12, 24, 52
    End point values
    Placebo PF-04950615 150 mg
    Number of subjects analysed
    354
    357
    Units: mg/dL
    arithmetic mean (standard deviation)
        Baseline (n =353, 357)
    114.3 ± 34.22
    115.5 ± 37.99
        Change at Week 12 (n =329, 336)
    -0.2 ± 23.55
    -63.3 ± 39
        Change at Week 24 (n =331, 336)
    5.5 ± 33.14
    -56 ± 39.34
        Change at Week 52 (n =311, 313)
    3.9 ± 32.17
    -45.9 ± 46.43
    Statistical analysis title
    Week 12
    Statistical analysis description
    LS-mean difference, associated 95% confidence intervals were derived from MMRM model with fixed effects for treatment group, visit, treatment group*visit interaction, baseline value, baseline value*visit interaction, geographical region, triglyceride subgroup.
    Comparison groups
    Placebo v PF-04950615 150 mg
    Number of subjects included in analysis
    711
    Analysis specification
    Pre-specified
    Analysis type
    other
    Method
    Parameter type
    LS mean difference
    Point estimate
    -63.4
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -68
         upper limit
    -58.8
    Variability estimate
    Standard error of the mean
    Dispersion value
    2.35

    Secondary: Absolute Change From Baseline in Total Cholesterol (TC) at Week 12, 24 and 52

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    End point title
    Absolute Change From Baseline in Total Cholesterol (TC) at Week 12, 24 and 52
    End point description
    FAS included all subjects who were randomized. Here, ‘n’ signifies those subjects who were evaluable at specified time points for each arm.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 12, 24, 52
    End point values
    Placebo PF-04950615 150 mg
    Number of subjects analysed
    354
    357
    Units: mg/dL
    arithmetic mean (standard deviation)
        Baseline (n =354, 357)
    186 ± 40.04
    189 ± 44.68
        Change at Week 12 (n =330, 340)
    0.6 ± 27.64
    -66.8 ± 42.38
        Change at Week 24 (n =331, 337)
    5.1 ± 35.83
    -60.1 ± 43.33
        Change at Week 52 (n =313, 315)
    1.8 ± 35.18
    -51.9 ± 49.68
    Statistical analysis title
    Week 12
    Statistical analysis description
    LS-mean difference, associated 95% confidence intervals were derived from MMRM model with fixed effects for treatment group, visit, treatment group*visit interaction, baseline value, baseline value*visit interaction, geographical region, triglyceride subgroup.
    Comparison groups
    Placebo v PF-04950615 150 mg
    Number of subjects included in analysis
    711
    Analysis specification
    Pre-specified
    Analysis type
    other
    Method
    Parameter type
    LS mean difference
    Point estimate
    -67.1
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -72.2
         upper limit
    -62.1
    Variability estimate
    Standard error of the mean
    Dispersion value
    2.59

    Secondary: Absolute Change From Baseline in Non-High Density Lipoprotein Cholesterol (Non-HDL-C) at Week 12, 24 and 52

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    End point title
    Absolute Change From Baseline in Non-High Density Lipoprotein Cholesterol (Non-HDL-C) at Week 12, 24 and 52
    End point description
    FAS included all subjects who were randomized. Here, ‘n’ signifies those subjects who were evaluable at specified time points for each arm.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 12, 24, 52
    End point values
    Placebo PF-04950615 150 mg
    Number of subjects analysed
    354
    357
    Units: mg/dL
    arithmetic mean (standard deviation)
        Baseline (n =354, 357)
    137.2 ± 37.38
    140.1 ± 43.48
        Change at Week 12 (n =330, 339)
    0.3 ± 26.53
    -69.8 ± 43.53
        Change at Week 24 (n =329, 336)
    5.2 ± 35.91
    -63.6 ± 44.37
        Change at Week 52 (n =312, 314)
    1.3 ± 33.93
    -53.9 ± 51.1
    Statistical analysis title
    Week 12
    Statistical analysis description
    LS-mean difference, associated 95% confidence intervals were derived from MMRM model with fixed effects for treatment group, visit, treatment group*visit interaction, baseline value, baseline value*visit interaction, geographical region, triglyceride subgroup.
    Comparison groups
    Placebo v PF-04950615 150 mg
    Number of subjects included in analysis
    711
    Analysis specification
    Pre-specified
    Analysis type
    other
    Method
    Parameter type
    LS mean difference
    Point estimate
    -69.7
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -74.7
         upper limit
    -64.6
    Variability estimate
    Standard error of the mean
    Dispersion value
    2.57

    Secondary: Absolute Change From Baseline in Apolipoprotein-B (ApoB) at Week 12, 24 and 52

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    End point title
    Absolute Change From Baseline in Apolipoprotein-B (ApoB) at Week 12, 24 and 52
    End point description
    FAS included all subjects who were randomized. Here, ‘n’ signifies those subjects who were evaluable at specified time point for each arm.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 12, 24, 52
    End point values
    Placebo PF-04950615 150 mg
    Number of subjects analysed
    354
    357
    Units: mg/dL
    arithmetic mean (standard deviation)
        Baseline (n =354, 357)
    94 ± 21.51
    95.1 ± 25.57
        Change at Week 12 (n =330, 339)
    -0.5 ± 17.32
    -47.9 ± 28.4
        Change at Week 24 (n =331, 335)
    2.5 ± 19.87
    -43.9 ± 29.95
        Change at Week 52 (n =313, 313)
    0.9 ± 20.59
    -36.4 ± 32.23
    Statistical analysis title
    Week 12
    Statistical analysis description
    LS-mean difference, associated 95% confidence intervals were derived from MMRM model with fixed effects for treatment group, visit, treatment group*visit interaction, baseline value, baseline value*visit interaction, geographical region, triglyceride subgroup.
    Comparison groups
    Placebo v PF-04950615 150 mg
    Number of subjects included in analysis
    711
    Analysis specification
    Pre-specified
    Analysis type
    other
    Method
    Parameter type
    LS mean difference
    Point estimate
    -47.3
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -50.7
         upper limit
    -43.8
    Variability estimate
    Standard error of the mean
    Dispersion value
    1.74

    Secondary: Absolute Change From Baseline in Lipoprotein(a) at Week 12, 24 and 52

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    End point title
    Absolute Change From Baseline in Lipoprotein(a) at Week 12, 24 and 52
    End point description
    FAS included all subjects who were randomized. Here, ‘n’ signifies those subjects who were evaluable at specified time points for each arm.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 12, 24, 52
    End point values
    Placebo PF-04950615 150 mg
    Number of subjects analysed
    354
    357
    Units: mg/dL
    arithmetic mean (standard deviation)
        Baseline (n =353, 356)
    44 ± 45.93
    45.1 ± 52.3
        Change at Week 12 (n =330, 339)
    -0.6 ± 10.42
    -11.4 ± 22.19
        Change at Week 24 (n =331, 336)
    -1.2 ± 12.62
    -10.6 ± 20.16
        Change at Week 52 (n =311, 311)
    -1 ± 10.71
    -8.6 ± 23.78
    Statistical analysis title
    Week 12
    Statistical analysis description
    LS-mean difference, associated 95% confidence intervals were derived from MMRM model with fixed effects for treatment group, visit, treatment group*visit interaction, baseline value, baseline value*visit interaction, geographical region, triglyceride subgroup.
    Comparison groups
    Placebo v PF-04950615 150 mg
    Number of subjects included in analysis
    711
    Analysis specification
    Pre-specified
    Analysis type
    other
    Method
    Parameter type
    LS mean difference
    Point estimate
    -10.6
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -12.9
         upper limit
    -8.3
    Variability estimate
    Standard error of the mean
    Dispersion value
    1.17

    Secondary: Absolute Change From Baseline in High Density Lipoprotein Cholesterol (HDL-C) at Week 12, 24 and 52

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    End point title
    Absolute Change From Baseline in High Density Lipoprotein Cholesterol (HDL-C) at Week 12, 24 and 52
    End point description
    FAS included all subjects who were randomized. Here, ‘n’ signifies those subjects who were evaluable at specified time points for each arm.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 12, 24, 52
    End point values
    Placebo PF-04950615 150 mg
    Number of subjects analysed
    354
    357
    Units: mg/dL
    arithmetic mean (standard deviation)
        Baseline (n =354, 357)
    48.7 ± 12.52
    49 ± 13.23
        Change at Week 12 (n =330, 339)
    0.4 ± 7.5
    2.9 ± 6.92
        Change at Week 24 (n =329, 336)
    0 ± 7.9
    3.3 ± 7.41
        Change at Week 52 (n =312, 314)
    0.6 ± 7.59
    2.1 ± 8.32
    Statistical analysis title
    Week 12
    Statistical analysis description
    LS-mean difference, associated 95% confidence intervals were derived from MMRM model with fixed effects for treatment group, visit, treatment group*visit interaction, baseline value, baseline value*visit interaction, geographical region, triglyceride subgroup.
    Comparison groups
    Placebo v PF-04950615 150 mg
    Number of subjects included in analysis
    711
    Analysis specification
    Pre-specified
    Analysis type
    other
    Method
    Parameter type
    LS mean difference
    Point estimate
    2.4
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    1.4
         upper limit
    3.5
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.55

    Secondary: Absolute Change From Baseline in Ratio of Fasting Total Cholesterol to High Density Lipoprotein-Cholesterol (TC/HDL-C ratio) at Week 12, 24 and 52

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    End point title
    Absolute Change From Baseline in Ratio of Fasting Total Cholesterol to High Density Lipoprotein-Cholesterol (TC/HDL-C ratio) at Week 12, 24 and 52
    End point description
    FAS included all subjects who were randomized. Here, ‘n’ signifies those subjects who were evaluable at specified time points for each arm.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 12, 24, 52
    End point values
    Placebo PF-04950615 150 mg
    Number of subjects analysed
    354
    357
    Units: ratio
    arithmetic mean (standard deviation)
        Baseline (n =354, 357)
    4 ± 1.1
    4.1 ± 1.26
        Change at Week 12 (n =330, 339)
    0 ± 0.71
    -1.6 ± 1.17
        Change at Week 24 (n =329, 336)
    0.1 ± 0.93
    -1.5 ± 1.21
        Change at Week 52 (n =312, 314)
    0 ± 0.85
    -1.2 ± 1.35
    Statistical analysis title
    Week 12
    Statistical analysis description
    LS-mean difference, associated 95% confidence intervals were derived from MMRM model with fixed effects for treatment group, visit, treatment group*visit interaction, baseline value, baseline value*visit interaction, geographical region, triglyceride subgroup.
    Comparison groups
    Placebo v PF-04950615 150 mg
    Number of subjects included in analysis
    711
    Analysis specification
    Pre-specified
    Analysis type
    other
    Method
    Parameter type
    LS mean difference
    Point estimate
    -1.6
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -1.7
         upper limit
    -1.4
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.06
    Statistical analysis title
    Week 24
    Statistical analysis description
    LS-mean difference, associated 95% confidence intervals were derived from MMRM model with fixed effects for treatment group, visit, treatment group*visit interaction, baseline value, baseline value*visit interaction, geographical region, triglyceride subgroup.
    Comparison groups
    Placebo v PF-04950615 150 mg
    Number of subjects included in analysis
    711
    Analysis specification
    Pre-specified
    Analysis type
    other
    Method
    Parameter type
    LS mean difference
    Point estimate
    -1.5
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -1.7
         upper limit
    -1.4
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.08
    Statistical analysis title
    Week 52
    Statistical analysis description
    LS-mean difference, associated 95% confidence intervals were derived from MMRM model with fixed effects for treatment group, visit, treatment group*visit interaction, baseline value, baseline value*visit interaction, geographical region, triglyceride subgroup.
    Comparison groups
    Placebo v PF-04950615 150 mg
    Number of subjects included in analysis
    711
    Analysis specification
    Pre-specified
    Analysis type
    other
    Method
    Parameter type
    LS mean difference
    Point estimate
    -1.2
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -1.4
         upper limit
    -1
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.08

    Secondary: Absolute Change From Baseline in Ratio of Apolipoprotein-B to ApolipoproteinA-I (ApoB/ApoA-I ratio) at Week 12, 24 and 52

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    End point title
    Absolute Change From Baseline in Ratio of Apolipoprotein-B to ApolipoproteinA-I (ApoB/ApoA-I ratio) at Week 12, 24 and 52
    End point description
    FAS included all subjects who were randomized. Here, ‘n’ signifies those subjects who were evaluable at specified time points for each arm.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 12, 24, 52
    End point values
    Placebo PF-04950615 150 mg
    Number of subjects analysed
    354
    357
    Units: ratio
    arithmetic mean (standard deviation)
        Baseline (n =354, 357)
    0.7 ± 0.18
    0.7 ± 0.21
        Change at Week 12 (n =330, 339)
    0 ± 0.12
    -0.3 ± 0.21
        Change at Week 24 (n =331, 335)
    0 ± 0.16
    -0.3 ± 0.24
        Change at Week 52 (n =313, 313)
    0 ± 0.14
    -0.3 ± 0.25
    Statistical analysis title
    Week 12
    Statistical analysis description
    LS-mean difference, associated 95% confidence intervals were derived from MMRM model with fixed effects for treatment group, visit, treatment group*visit interaction, baseline value, baseline value*visit interaction, geographical region, triglyceride subgroup.
    Comparison groups
    Placebo v PF-04950615 150 mg
    Number of subjects included in analysis
    711
    Analysis specification
    Pre-specified
    Analysis type
    other
    Method
    Parameter type
    LS mean difference
    Point estimate
    -0.3
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -0.4
         upper limit
    -0.3
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.01
    Statistical analysis title
    Week 24
    Statistical analysis description
    LS-mean difference, associated 95% confidence intervals were derived from MMRM model with fixed effects for treatment group, visit, treatment group*visit interaction, baseline value, baseline value*visit interaction, geographical region, triglyceride subgroup.
    Comparison groups
    Placebo v PF-04950615 150 mg
    Number of subjects included in analysis
    711
    Analysis specification
    Pre-specified
    Analysis type
    other
    Method
    Parameter type
    LS mean difference
    Point estimate
    -0.3
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -0.4
         upper limit
    -0.3
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.01
    Statistical analysis title
    Week 52
    Statistical analysis description
    LS-mean difference, associated 95% confidence intervals were derived from MMRM model with fixed effects for treatment group, visit, treatment group*visit interaction, baseline value, baseline value*visit interaction, geographical region, triglyceride subgroup.
    Comparison groups
    Placebo v PF-04950615 150 mg
    Number of subjects included in analysis
    711
    Analysis specification
    Pre-specified
    Analysis type
    other
    Method
    Parameter type
    LS mean difference
    Point estimate
    -0.3
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -0.3
         upper limit
    -0.2
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.02

    Secondary: Percentage of Subjects Achieving Fasting Low Density Lipoprotein-Cholesterol (LDL-C) Less Than or Equal to (<=) 100 Milligram per Deciliter (2.59 Millimoles per Litre) at Week 12, 24 and 52

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    End point title
    Percentage of Subjects Achieving Fasting Low Density Lipoprotein-Cholesterol (LDL-C) Less Than or Equal to (<=) 100 Milligram per Deciliter (2.59 Millimoles per Litre) at Week 12, 24 and 52
    End point description
    FAS included all subjects who were randomized. Here, ‘n’ signifies those subjects who were evaluable at specified time points for each arm.
    End point type
    Secondary
    End point timeframe
    Week 12, 24 and 52
    End point values
    Placebo PF-04950615 150 mg
    Number of subjects analysed
    354
    357
    Units: percentage of subjects
    number (not applicable)
        Week 12 (n =330, 336)
    41.5
    87.5
        Week 24 (n =332, 336)
    37.3
    82.1
        Week 52 (n =312, 313)
    36.9
    77.3
    Statistical analysis title
    Week 12
    Comparison groups
    Placebo v PF-04950615 150 mg
    Number of subjects included in analysis
    711
    Analysis specification
    Pre-specified
    Analysis type
    other
    Method
    Parameter type
    Odds ratio (OR)
    Point estimate
    24
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    13.86
         upper limit
    41.64
    Statistical analysis title
    Week 24
    Comparison groups
    Placebo v PF-04950615 150 mg
    Number of subjects included in analysis
    711
    Analysis specification
    Pre-specified
    Analysis type
    other
    Method
    Parameter type
    Odds ratio (OR)
    Point estimate
    14.8
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    9.32
         upper limit
    23.56
    Statistical analysis title
    Week 52
    Comparison groups
    Placebo v PF-04950615 150 mg
    Number of subjects included in analysis
    711
    Analysis specification
    Pre-specified
    Analysis type
    other
    Method
    Parameter type
    Odds ratio (OR)
    Point estimate
    9.8
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    6.36
         upper limit
    15.24

    Secondary: Percentage of Subjects Achieving Fasting Low Density Lipoprotein-Cholesterol (LDL-C) Less Than or Equal to (<=) 70 Milligram per Deciliter (1.81 Millimoles per Litre) at Week 12, 24 and 52

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    End point title
    Percentage of Subjects Achieving Fasting Low Density Lipoprotein-Cholesterol (LDL-C) Less Than or Equal to (<=) 70 Milligram per Deciliter (1.81 Millimoles per Litre) at Week 12, 24 and 52
    End point description
    FAS included all subjects who were randomized. Here, ‘n’ signifies those subjects who were evaluable at specified time point for each arm.
    End point type
    Secondary
    End point timeframe
    Week 12, 24 and 52
    End point values
    Placebo PF-04950615 150 mg
    Number of subjects analysed
    354
    357
    Units: percentage of subjects
    number (not applicable)
        Week 12 (n =330, 336)
    5.5
    76.8
        Week 24 (n =332, 336)
    3.3
    69.6
        Week 52 (n =312, 313)
    6.4
    61.7
    Statistical analysis title
    Week 12
    Comparison groups
    Placebo v PF-04950615 150 mg
    Number of subjects included in analysis
    711
    Analysis specification
    Pre-specified
    Analysis type
    other
    Method
    Parameter type
    Odds ratio (OR)
    Point estimate
    95.2
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    52.09
         upper limit
    173.91
    Statistical analysis title
    Week 24
    Comparison groups
    Placebo v PF-04950615 150 mg
    Number of subjects included in analysis
    711
    Analysis specification
    Pre-specified
    Analysis type
    other
    Method
    Parameter type
    Odds ratio (OR)
    Point estimate
    112.2
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    55.81
         upper limit
    225.52
    Statistical analysis title
    Week 52
    Comparison groups
    Placebo v PF-04950615 150 mg
    Number of subjects included in analysis
    711
    Analysis specification
    Pre-specified
    Analysis type
    other
    Method
    Parameter type
    Odds ratio (OR)
    Point estimate
    29.1
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    17.13
         upper limit
    49.49

    Secondary: Plasma PF-04950615 Concentrations at Week 12, 24 and 52

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    End point title
    Plasma PF-04950615 Concentrations at Week 12, 24 and 52 [1]
    End point description
    Analysis set included subjects who received at least 1 dose of PF-04950615. Here, ‘n’ signifies those subjects who were evaluable at specified time points.
    End point type
    Secondary
    End point timeframe
    Week 12, 24, 52
    Notes
    [1] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: No statistical analysis was performed for this endpoint.
    End point values
    PF-04950615 150 mg
    Number of subjects analysed
    356
    Units: microgram per milliliter
    arithmetic mean (standard deviation)
        Week 12 (n =332)
    5.53 ± 5.666
        Week 24 (n =327)
    5.36 ± 6.029
        Week 52 (n =306)
    4.07 ± 4.947
    No statistical analyses for this end point

    Secondary: Number of Subjects With Adverse Events (AEs) Related to Type 1 or 3 Hypersensitivity Reactions and Injection Site Reactions

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    End point title
    Number of Subjects With Adverse Events (AEs) Related to Type 1 or 3 Hypersensitivity Reactions and Injection Site Reactions
    End point description
    Type 1 hypersensitivity or allergic reactions were possible in response to any injected protein and included shortness of breath, urticaria, anaphylaxis and angioedema. Type 3 hypersensitivity reactions were similar to Type 1 hypersensitivity reactions but were likely to be delayed from the time of injection and included symptoms such as rash, urticaria, polyarthritis, myalgia’s, polysynovitis, fever and if severe then included glomerulonephritis as well. Injection site reactions included injection site bruising, discolouration, erythema, haematoma, haemorrhage, nodule, induration, pain, pruritus and rash. Subjects with type 1 or type 3 hypersensitivity reactions and participants with injection site reactions were reported in this endpoint. Safety analysis set included all subjects who received at least 1 dose of study treatment.
    End point type
    Secondary
    End point timeframe
    Baseline up to the end of study (up to 58 weeks)
    End point values
    Placebo PF-04950615 150 mg
    Number of subjects analysed
    353
    356
    Units: subjects
        Type 1 or 3 hypersensitivity reactions
    2
    1
        Injection site reactions
    5
    42
    No statistical analyses for this end point

    Secondary: Percentage of Subjects With PF-04950615 Anti-Drug Antibodies (ADA) and Neutralizing Antibodies (nAb)

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    End point title
    Percentage of Subjects With PF-04950615 Anti-Drug Antibodies (ADA) and Neutralizing Antibodies (nAb) [2]
    End point description
    Percentage of subjects with at least 1 positive ADA titer and 1 positive nAb titer were reported. Subjects with their ADA titer >=6.23 were considered to be ADA positive and participants with their nAb titer >=1.58 were considered to be nAb positive. Safety analysis set includes all subjects who received at least 1 dose of study treatment. Here, "number of subjects analyzed" signifies those subjects who were evaluable in this endpoint.
    End point type
    Secondary
    End point timeframe
    Baseline up to the end of study (up to 58 weeks)
    Notes
    [2] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: No statistical analysis was performed for this endpoint.
    End point values
    PF-04950615 150 mg
    Number of subjects analysed
    352
    Units: percentage of subjects
        ADA
    44
        nAb
    27
    No statistical analyses for this end point

    Other pre-specified: Absolute Change From Baseline in Triglyceride (TG) at Week 12, 24 and 52

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    End point title
    Absolute Change From Baseline in Triglyceride (TG) at Week 12, 24 and 52
    End point description
    FAS included all subjects who were randomized. Here, ‘n’ signifies those subjects who were evaluable at specified time points for each arm.
    End point type
    Other pre-specified
    End point timeframe
    Baseline, Week 12, 24, 52
    End point values
    Placebo PF-04950615 150 mg
    Number of subjects analysed
    354
    357
    Units: mg/dL
    arithmetic mean (standard deviation)
        Baseline (n =354, 357)
    149.5 ± 66.83
    156.2 ± 78.75
        Change at Week 12 (n =330, 340)
    3.8 ± 57.04
    -23 ± 71.52
        Change at Week 24 (n =331, 336)
    5 ± 64.34
    -28.9 ± 68.41
        Change at Week 52 (n =313, 315)
    -7.7 ± 64.14
    -24.3 ± 82.21
    No statistical analyses for this end point

    Other pre-specified: Absolute Change From Baseline in ApolipoproteinA-I (ApoA-I) at Week 12, 24 and 52

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    End point title
    Absolute Change From Baseline in ApolipoproteinA-I (ApoA-I) at Week 12, 24 and 52
    End point description
    FAS included all subjects who were randomized. Here, ‘n’ signifies those subjects who were evaluable at specified time points for each arm.
    End point type
    Other pre-specified
    End point timeframe
    Baseline, Week 12, 24, 52
    End point values
    Placebo PF-04950615 150 mg
    Number of subjects analysed
    354
    357
    Units: mg/dL
    arithmetic mean (standard deviation)
        Baseline (n =354, 357)
    147.5 ± 24.25
    147.2 ± 24.96
        Change at Week 12 (n =330, 339)
    -1.2 ± 19.46
    4.6 ± 18.32
        Change at Week 24 (n =331, 336)
    -2.3 ± 19.33
    5.6 ± 17.53
        Change at Week 52 (n =313, 313)
    -0.2 ± 19.56
    3.8 ± 18.86
    No statistical analyses for this end point

    Other pre-specified: Absolute Change From Baseline in ApolipoproteinA-II (ApoA-II) at Week 12, 24 and 52

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    End point title
    Absolute Change From Baseline in ApolipoproteinA-II (ApoA-II) at Week 12, 24 and 52
    End point description
    FAS included all subjects who were randomized. Here, ‘n’ signifies those subjects who were evaluable at specified time points for each arm.
    End point type
    Other pre-specified
    End point timeframe
    Baseline, Week 12, 24, 52
    End point values
    Placebo PF-04950615 150 mg
    Number of subjects analysed
    354
    357
    Units: mg/dL
    arithmetic mean (standard deviation)
        Baseline (n =353, 356)
    38.1 ± 6.46
    38.2 ± 6.58
        Change at Week 12 (n =327, 339)
    -0.9 ± 4.95
    -0.9 ± 4.63
        Change at Week 24 (n =331, 335)
    -1.7 ± 5.65
    -1 ± 5.07
        Change at Week 52 (n =310, 310)
    -1.5 ± 5.54
    -0.9 ± 5.15
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Baseline up to the end of study (up to 58 weeks)
    Adverse event reporting additional description
    The same events may occur as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
    Assessment type
    Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    MedDRA
    Dictionary version
    18.1
    Reporting groups
    Reporting group title
    Placebo
    Reporting group description
    Subjects received single dose of placebo matched to PF-04950615 subcutaneous injection once in every 2 weeks over a period of 52 weeks. Subjects were followed up to 58 weeks.

    Reporting group title
    PF-04950615 150 mg
    Reporting group description
    Subjects received single dose of PF-04950615 150 mg subcutaneous injection once in every 2 weeks over a period of 52 weeks. Subjects were followed up to 58 weeks.

    Serious adverse events
    Placebo PF-04950615 150 mg
    Total subjects affected by serious adverse events
         subjects affected / exposed
    40 / 353 (11.33%)
    45 / 356 (12.64%)
         number of deaths (all causes)
    3
    2
         number of deaths resulting from adverse events
    Vascular disorders
    Aortic aneurysm rupture
         subjects affected / exposed
    0 / 353 (0.00%)
    1 / 356 (0.28%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Aortic stenosis
         subjects affected / exposed
    0 / 353 (0.00%)
    1 / 356 (0.28%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Orthostatic hypotension
         subjects affected / exposed
    0 / 353 (0.00%)
    1 / 356 (0.28%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Peripheral arterial occlusive disease
         subjects affected / exposed
    1 / 353 (0.28%)
    0 / 356 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Peripheral vascular disorder
         subjects affected / exposed
    1 / 353 (0.28%)
    0 / 356 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Bladder cancer
         subjects affected / exposed
    0 / 353 (0.00%)
    2 / 356 (0.56%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Invasive ductal breast carcinoma
         subjects affected / exposed
    0 / 353 (0.00%)
    1 / 356 (0.28%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lung neoplasm malignant
         subjects affected / exposed
    2 / 353 (0.57%)
    0 / 356 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 2
    0 / 0
    Malignant melanoma of sites other than skin
         subjects affected / exposed
    1 / 353 (0.28%)
    0 / 356 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Metastases to central nervous system
         subjects affected / exposed
    1 / 353 (0.28%)
    0 / 356 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Prostate cancer
    Additional description: This is gender specific event. The number of subjects evaluable for this event were 224 and 221.
         subjects affected / exposed [1]
    1 / 224 (0.45%)
    0 / 221 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Chest pain
         subjects affected / exposed
    2 / 353 (0.57%)
    4 / 356 (1.12%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Non-cardiac chest pain
         subjects affected / exposed
    3 / 353 (0.85%)
    2 / 356 (0.56%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pyrexia
         subjects affected / exposed
    0 / 353 (0.00%)
    1 / 356 (0.28%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Psychiatric disorders
    Completed suicide
         subjects affected / exposed
    1 / 353 (0.28%)
    0 / 356 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Suicidal behaviour
         subjects affected / exposed
    0 / 353 (0.00%)
    1 / 356 (0.28%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    Craniocerebral injury
         subjects affected / exposed
    0 / 353 (0.00%)
    1 / 356 (0.28%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Fall
         subjects affected / exposed
    0 / 353 (0.00%)
    2 / 356 (0.56%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Femur fracture
         subjects affected / exposed
    1 / 353 (0.28%)
    0 / 356 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Humerus fracture
         subjects affected / exposed
    1 / 353 (0.28%)
    1 / 356 (0.28%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lumbar vertebral fracture
         subjects affected / exposed
    1 / 353 (0.28%)
    1 / 356 (0.28%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Patella fracture
         subjects affected / exposed
    1 / 353 (0.28%)
    0 / 356 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pelvic fracture
         subjects affected / exposed
    0 / 353 (0.00%)
    1 / 356 (0.28%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Subdural haematoma
         subjects affected / exposed
    1 / 353 (0.28%)
    1 / 356 (0.28%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vascular graft complication
         subjects affected / exposed
    1 / 353 (0.28%)
    0 / 356 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Wound
         subjects affected / exposed
    0 / 353 (0.00%)
    1 / 356 (0.28%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac disorders
    Acute coronary syndrome
         subjects affected / exposed
    1 / 353 (0.28%)
    0 / 356 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Angina pectoris
         subjects affected / exposed
    2 / 353 (0.57%)
    0 / 356 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Angina unstable
         subjects affected / exposed
    1 / 353 (0.28%)
    3 / 356 (0.84%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Atrial fibrillation
         subjects affected / exposed
    0 / 353 (0.00%)
    1 / 356 (0.28%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bradycardia
         subjects affected / exposed
    1 / 353 (0.28%)
    1 / 356 (0.28%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac failure
         subjects affected / exposed
    1 / 353 (0.28%)
    0 / 356 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac failure congestive
         subjects affected / exposed
    2 / 353 (0.57%)
    1 / 356 (0.28%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Coronary artery disease
         subjects affected / exposed
    2 / 353 (0.57%)
    2 / 356 (0.56%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Left ventricular failure
         subjects affected / exposed
    0 / 353 (0.00%)
    1 / 356 (0.28%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Myocardial infarction
         subjects affected / exposed
    3 / 353 (0.85%)
    5 / 356 (1.40%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 2
    Myocardial ischaemia
         subjects affected / exposed
    1 / 353 (0.28%)
    1 / 356 (0.28%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Silent myocardial infarction
         subjects affected / exposed
    0 / 353 (0.00%)
    1 / 356 (0.28%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ventricular extrasystoles
         subjects affected / exposed
    0 / 353 (0.00%)
    1 / 356 (0.28%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Asthma
         subjects affected / exposed
    1 / 353 (0.28%)
    0 / 356 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Dyspnoea
         subjects affected / exposed
    1 / 353 (0.28%)
    0 / 356 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pulmonary embolism
         subjects affected / exposed
    0 / 353 (0.00%)
    1 / 356 (0.28%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    0 / 353 (0.00%)
    1 / 356 (0.28%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Normochromic normocytic anaemia
         subjects affected / exposed
    1 / 353 (0.28%)
    0 / 356 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nervous system disorders
    Intracranial aneurysm
         subjects affected / exposed
    1 / 353 (0.28%)
    0 / 356 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lethargy
         subjects affected / exposed
    0 / 353 (0.00%)
    1 / 356 (0.28%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nerve root compression
         subjects affected / exposed
    1 / 353 (0.28%)
    0 / 356 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Presyncope
         subjects affected / exposed
    0 / 353 (0.00%)
    1 / 356 (0.28%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Subarachnoid haemorrhage
         subjects affected / exposed
    0 / 353 (0.00%)
    1 / 356 (0.28%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Syncope
         subjects affected / exposed
    1 / 353 (0.28%)
    1 / 356 (0.28%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Transient ischaemic attack
         subjects affected / exposed
    1 / 353 (0.28%)
    0 / 356 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Eye disorders
    Retinal aneurysm
         subjects affected / exposed
    1 / 353 (0.28%)
    0 / 356 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Retinal haemorrhage
         subjects affected / exposed
    1 / 353 (0.28%)
    0 / 356 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Faecaloma
         subjects affected / exposed
    0 / 353 (0.00%)
    1 / 356 (0.28%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastritis
         subjects affected / exposed
    1 / 353 (0.28%)
    0 / 356 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Inguinal hernia
         subjects affected / exposed
    0 / 353 (0.00%)
    1 / 356 (0.28%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Intestinal ischaemia
         subjects affected / exposed
    1 / 353 (0.28%)
    0 / 356 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Large intestine polyp
         subjects affected / exposed
    1 / 353 (0.28%)
    0 / 356 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Mesenteric artery stenosis
         subjects affected / exposed
    1 / 353 (0.28%)
    0 / 356 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pancreatitis acute
         subjects affected / exposed
    0 / 353 (0.00%)
    1 / 356 (0.28%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Small intestinal obstruction
         subjects affected / exposed
    1 / 353 (0.28%)
    0 / 356 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal and urinary disorders
    Acute kidney injury
         subjects affected / exposed
    2 / 353 (0.57%)
    0 / 356 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Skin and subcutaneous tissue disorders
    Angioedema
         subjects affected / exposed
    1 / 353 (0.28%)
    0 / 356 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Psoriasis
         subjects affected / exposed
    1 / 353 (0.28%)
    0 / 356 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Bursitis
         subjects affected / exposed
    0 / 353 (0.00%)
    1 / 356 (0.28%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Haemarthrosis
         subjects affected / exposed
    0 / 353 (0.00%)
    1 / 356 (0.28%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Musculoskeletal chest pain
         subjects affected / exposed
    1 / 353 (0.28%)
    0 / 356 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Musculoskeletal pain
         subjects affected / exposed
    0 / 353 (0.00%)
    1 / 356 (0.28%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Osteoarthritis
         subjects affected / exposed
    1 / 353 (0.28%)
    1 / 356 (0.28%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pain in extremity
         subjects affected / exposed
    0 / 353 (0.00%)
    1 / 356 (0.28%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Metabolism and nutrition disorders
    Dehydration
         subjects affected / exposed
    2 / 353 (0.57%)
    0 / 356 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypoglycaemia
         subjects affected / exposed
    0 / 353 (0.00%)
    1 / 356 (0.28%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Type 2 diabetes mellitus
         subjects affected / exposed
    0 / 353 (0.00%)
    1 / 356 (0.28%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    Appendicitis
         subjects affected / exposed
    1 / 353 (0.28%)
    0 / 356 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Appendicitis perforated
         subjects affected / exposed
    1 / 353 (0.28%)
    0 / 356 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Arthritis bacterial
         subjects affected / exposed
    1 / 353 (0.28%)
    0 / 356 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bursitis infective
         subjects affected / exposed
    1 / 353 (0.28%)
    0 / 356 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cellulitis
         subjects affected / exposed
    1 / 353 (0.28%)
    2 / 356 (0.56%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Diverticulitis
         subjects affected / exposed
    1 / 353 (0.28%)
    0 / 356 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Encephalitis
         subjects affected / exposed
    1 / 353 (0.28%)
    0 / 356 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Endocarditis staphylococcal
         subjects affected / exposed
    0 / 353 (0.00%)
    1 / 356 (0.28%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastroenteritis
         subjects affected / exposed
    1 / 353 (0.28%)
    0 / 356 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastroenteritis viral
         subjects affected / exposed
    0 / 353 (0.00%)
    1 / 356 (0.28%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hepatitis B
         subjects affected / exposed
    0 / 353 (0.00%)
    1 / 356 (0.28%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumonia
         subjects affected / exposed
    1 / 353 (0.28%)
    1 / 356 (0.28%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Sepsis
         subjects affected / exposed
    1 / 353 (0.28%)
    0 / 356 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Staphylococcal bacteraemia
         subjects affected / exposed
    0 / 353 (0.00%)
    1 / 356 (0.28%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Urinary tract infection
         subjects affected / exposed
    0 / 353 (0.00%)
    1 / 356 (0.28%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Urosepsis
         subjects affected / exposed
    0 / 353 (0.00%)
    1 / 356 (0.28%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Notes
    [1] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
    Justification: This is gender specific event. The number of subjects evaluable for this event were 224 and 221.
    Frequency threshold for reporting non-serious adverse events: 1%
    Non-serious adverse events
    Placebo PF-04950615 150 mg
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    185 / 353 (52.41%)
    205 / 356 (57.58%)
    Vascular disorders
    Hypertension
         subjects affected / exposed
    11 / 353 (3.12%)
    12 / 356 (3.37%)
         occurrences all number
    12
    12
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Basal cell carcinoma
         subjects affected / exposed
    4 / 353 (1.13%)
    1 / 356 (0.28%)
         occurrences all number
    4
    1
    General disorders and administration site conditions
    Chest pain
         subjects affected / exposed
    4 / 353 (1.13%)
    2 / 356 (0.56%)
         occurrences all number
    4
    2
    Fatigue
         subjects affected / exposed
    5 / 353 (1.42%)
    7 / 356 (1.97%)
         occurrences all number
    6
    8
    Injection site bruising
         subjects affected / exposed
    2 / 353 (0.57%)
    5 / 356 (1.40%)
         occurrences all number
    3
    9
    Injection site erythema
         subjects affected / exposed
    3 / 353 (0.85%)
    9 / 356 (2.53%)
         occurrences all number
    3
    17
    Injection site haemorrhage
         subjects affected / exposed
    2 / 353 (0.57%)
    4 / 356 (1.12%)
         occurrences all number
    5
    5
    Injection site pain
         subjects affected / exposed
    4 / 353 (1.13%)
    6 / 356 (1.69%)
         occurrences all number
    32
    8
    Injection site pruritus
         subjects affected / exposed
    0 / 353 (0.00%)
    4 / 356 (1.12%)
         occurrences all number
    0
    4
    Injection site reaction
         subjects affected / exposed
    5 / 353 (1.42%)
    42 / 356 (11.80%)
         occurrences all number
    7
    175
    Non-cardiac chest pain
         subjects affected / exposed
    5 / 353 (1.42%)
    1 / 356 (0.28%)
         occurrences all number
    7
    1
    Pain
         subjects affected / exposed
    5 / 353 (1.42%)
    0 / 356 (0.00%)
         occurrences all number
    5
    0
    Psychiatric disorders
    Anxiety
         subjects affected / exposed
    5 / 353 (1.42%)
    1 / 356 (0.28%)
         occurrences all number
    5
    1
    Depression
         subjects affected / exposed
    3 / 353 (0.85%)
    6 / 356 (1.69%)
         occurrences all number
    3
    6
    Reproductive system and breast disorders
    Benign prostatic hyperplasia
    Additional description: This is gender specific event. The number of subjects evaluable for this event were 224 and 221.
         subjects affected / exposed [2]
    3 / 224 (1.34%)
    1 / 221 (0.45%)
         occurrences all number
    3
    1
    Injury, poisoning and procedural complications
    Contusion
         subjects affected / exposed
    2 / 353 (0.57%)
    4 / 356 (1.12%)
         occurrences all number
    2
    4
    Fall
         subjects affected / exposed
    13 / 353 (3.68%)
    10 / 356 (2.81%)
         occurrences all number
    13
    11
    Muscle strain
         subjects affected / exposed
    1 / 353 (0.28%)
    5 / 356 (1.40%)
         occurrences all number
    1
    6
    Investigations
    Alanine aminotransferase increased
         subjects affected / exposed
    4 / 353 (1.13%)
    0 / 356 (0.00%)
         occurrences all number
    4
    0
    Blood cortisol decreased
         subjects affected / exposed
    5 / 353 (1.42%)
    6 / 356 (1.69%)
         occurrences all number
    5
    7
    Blood creatine phosphokinase increased
         subjects affected / exposed
    4 / 353 (1.13%)
    3 / 356 (0.84%)
         occurrences all number
    4
    3
    Gamma-glutamyltransferase increased
         subjects affected / exposed
    6 / 353 (1.70%)
    1 / 356 (0.28%)
         occurrences all number
    6
    1
    Vitamin D decreased
         subjects affected / exposed
    3 / 353 (0.85%)
    5 / 356 (1.40%)
         occurrences all number
    3
    5
    Cardiac disorders
    Angina pectoris
         subjects affected / exposed
    4 / 353 (1.13%)
    5 / 356 (1.40%)
         occurrences all number
    4
    5
    Palpitations
         subjects affected / exposed
    2 / 353 (0.57%)
    4 / 356 (1.12%)
         occurrences all number
    2
    5
    Respiratory, thoracic and mediastinal disorders
    Chronic obstructive pulmonary disease
         subjects affected / exposed
    3 / 353 (0.85%)
    6 / 356 (1.69%)
         occurrences all number
    3
    7
    Cough
         subjects affected / exposed
    9 / 353 (2.55%)
    8 / 356 (2.25%)
         occurrences all number
    10
    8
    Dyspnoea
         subjects affected / exposed
    6 / 353 (1.70%)
    3 / 356 (0.84%)
         occurrences all number
    6
    3
    Sleep apnoea syndrome
         subjects affected / exposed
    2 / 353 (0.57%)
    4 / 356 (1.12%)
         occurrences all number
    2
    4
    Nervous system disorders
    Dizziness
         subjects affected / exposed
    12 / 353 (3.40%)
    1 / 356 (0.28%)
         occurrences all number
    12
    1
    Headache
         subjects affected / exposed
    14 / 353 (3.97%)
    8 / 356 (2.25%)
         occurrences all number
    14
    8
    Hypoaesthesia
         subjects affected / exposed
    4 / 353 (1.13%)
    1 / 356 (0.28%)
         occurrences all number
    4
    1
    Gastrointestinal disorders
    Abdominal pain
         subjects affected / exposed
    4 / 353 (1.13%)
    4 / 356 (1.12%)
         occurrences all number
    4
    4
    Constipation
         subjects affected / exposed
    4 / 353 (1.13%)
    8 / 356 (2.25%)
         occurrences all number
    5
    8
    Diarrhoea
         subjects affected / exposed
    6 / 353 (1.70%)
    12 / 356 (3.37%)
         occurrences all number
    7
    13
    Dyspepsia
         subjects affected / exposed
    4 / 353 (1.13%)
    1 / 356 (0.28%)
         occurrences all number
    4
    1
    Gastrooesophageal reflux disease
         subjects affected / exposed
    5 / 353 (1.42%)
    3 / 356 (0.84%)
         occurrences all number
    5
    3
    Nausea
         subjects affected / exposed
    7 / 353 (1.98%)
    7 / 356 (1.97%)
         occurrences all number
    8
    9
    Vomiting
         subjects affected / exposed
    5 / 353 (1.42%)
    4 / 356 (1.12%)
         occurrences all number
    5
    7
    Skin and subcutaneous tissue disorders
    Rash
         subjects affected / exposed
    4 / 353 (1.13%)
    3 / 356 (0.84%)
         occurrences all number
    4
    3
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    7 / 353 (1.98%)
    13 / 356 (3.65%)
         occurrences all number
    8
    15
    Back pain
         subjects affected / exposed
    8 / 353 (2.27%)
    15 / 356 (4.21%)
         occurrences all number
    9
    17
    Muscle spasms
         subjects affected / exposed
    8 / 353 (2.27%)
    4 / 356 (1.12%)
         occurrences all number
    9
    5
    Musculoskeletal pain
         subjects affected / exposed
    5 / 353 (1.42%)
    7 / 356 (1.97%)
         occurrences all number
    5
    7
    Myalgia
         subjects affected / exposed
    9 / 353 (2.55%)
    8 / 356 (2.25%)
         occurrences all number
    9
    9
    Osteoarthritis
         subjects affected / exposed
    3 / 353 (0.85%)
    5 / 356 (1.40%)
         occurrences all number
    3
    5
    Pain in extremity
         subjects affected / exposed
    11 / 353 (3.12%)
    5 / 356 (1.40%)
         occurrences all number
    12
    5
    Tendonitis
         subjects affected / exposed
    2 / 353 (0.57%)
    4 / 356 (1.12%)
         occurrences all number
    2
    4
    Metabolism and nutrition disorders
    Diabetes mellitus
         subjects affected / exposed
    3 / 353 (0.85%)
    4 / 356 (1.12%)
         occurrences all number
    3
    4
    Hypoglycaemia
         subjects affected / exposed
    4 / 353 (1.13%)
    5 / 356 (1.40%)
         occurrences all number
    4
    6
    Type 2 diabetes mellitus
         subjects affected / exposed
    5 / 353 (1.42%)
    4 / 356 (1.12%)
         occurrences all number
    5
    4
    Vitamin D deficiency
         subjects affected / exposed
    36 / 353 (10.20%)
    19 / 356 (5.34%)
         occurrences all number
    36
    19
    Infections and infestations
    Acute sinusitis
         subjects affected / exposed
    3 / 353 (0.85%)
    5 / 356 (1.40%)
         occurrences all number
    4
    5
    Bronchitis
         subjects affected / exposed
    14 / 353 (3.97%)
    13 / 356 (3.65%)
         occurrences all number
    16
    13
    Cellulitis
         subjects affected / exposed
    4 / 353 (1.13%)
    2 / 356 (0.56%)
         occurrences all number
    4
    2
    Gastroenteritis
         subjects affected / exposed
    8 / 353 (2.27%)
    2 / 356 (0.56%)
         occurrences all number
    8
    2
    Herpes zoster
         subjects affected / exposed
    3 / 353 (0.85%)
    4 / 356 (1.12%)
         occurrences all number
    3
    4
    Influenza
         subjects affected / exposed
    7 / 353 (1.98%)
    10 / 356 (2.81%)
         occurrences all number
    7
    13
    Nasopharyngitis
         subjects affected / exposed
    27 / 353 (7.65%)
    26 / 356 (7.30%)
         occurrences all number
    32
    31
    Pharyngitis
         subjects affected / exposed
    3 / 353 (0.85%)
    6 / 356 (1.69%)
         occurrences all number
    5
    6
    Pneumonia
         subjects affected / exposed
    1 / 353 (0.28%)
    8 / 356 (2.25%)
         occurrences all number
    1
    8
    Rhinitis
         subjects affected / exposed
    1 / 353 (0.28%)
    4 / 356 (1.12%)
         occurrences all number
    1
    4
    Sinusitis
         subjects affected / exposed
    5 / 353 (1.42%)
    10 / 356 (2.81%)
         occurrences all number
    5
    10
    Upper respiratory tract infection
         subjects affected / exposed
    19 / 353 (5.38%)
    14 / 356 (3.93%)
         occurrences all number
    23
    17
    Urinary tract infection
         subjects affected / exposed
    6 / 353 (1.70%)
    11 / 356 (3.09%)
         occurrences all number
    6
    14
    Notes
    [2] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: This is gender specific event. The number of subjects evaluable for this event were 224 and 221.

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    Substantial protocol amendments (globally)

    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    19 Jun 2014
    1. Reduced treatment duration from 80 to 52 weeks; reduced study follow-up period from 8 to 6 weeks. 2. Classified VLDL-C as a secondary endpoint rather than an exploratory endpoint.

    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
    The status of studies in GB is no longer updated from 1.1.2021
    For the UK, as from 1.1.2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI
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