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    Clinical Trial Results:
    REVEAL: Randomized EValuation of the Effects of Anacetrapib through Lipid-modification. A large-scale, randomized placebo-controlled trial of the clinical effects of anacetrapib among people with established vascular disease

    Summary
    EudraCT number
    2010-023467-18
    Trial protocol
    GB   SE   DK   FI   DE   IT  
    Global end of trial date

    Results information
    Results version number
    v1(current)
    This version publication date
    14 Sep 2018
    First version publication date
    14 Sep 2018
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    CTSUREVEAL1
    Additional study identifiers
    ISRCTN number
    ISRCTN48678192
    US NCT number
    NCT01252953
    WHO universal trial number (UTN)
    -
    Sponsors
    Sponsor organisation name
    University of Oxford
    Sponsor organisation address
    Joint Research Office, Block 60, Churchill Hospital, Old Road, Oxford, United Kingdom, OX3 7LE
    Public contact
    REVEAL Study team, CTSU, Nuffield Department of Population Health, +44 01865743743, reveal@ndph.ox.ac.uk
    Scientific contact
    Martin Landray, CTSU, Nuffield Department of Population Health, +44 01865743743, martin.landray@ndph.ox.ac.uk
    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
    Interim
    Date of interim/final analysis
    15 May 2017
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    31 Jan 2017
    Global end of trial reached?
    No
    General information about the trial
    Main objective of the trial
    The primary objective is to assess the effect of lipid modification using anacetrapib 100mg daily versus placebo on the time to first "major coronary event" (defined as the occurrence of coronary death, myocardial infarction or coronary revascularization procedure) during the scheduled treatment period.
    Protection of trial subjects
    At each visit details of hospital admissions, other Serious Adverse Events, unexplained muscle pain or weakness, and non-serious adverse events attributed to study treatment were sought. Liver function was also checked at each follow-up visit. Participants were provided with a 24-hour Freefone number should they wish to discuss trial-related medical problems outside of the normal working hours.
    Background therapy
    Atorvastatin 10mg, 20mg or 80mg In China, atorvastatin 10mg or 20mg daily was used. Elsewhere the dose was 20mg or 80mg.
    Evidence for comparator
    When used either as monotherapy or in combination with a statin, the CETP inhibitor anacetrapib more than doubles HDL cholesterol concentration and also reduces non-HDL cholesterol concentration. In early phase studies completed prior to initiation of REVEAL, anacetrapib was well tolerated and had no effects on blood pressure or aldosterone levels. The REVEAL trial set out to assess whether the lipid changes produced by anacetrapib would reduce the risk of vascular events when used in addition to effective doses of a statin.
    Actual start date of recruitment
    22 Aug 2011
    Long term follow-up planned
    Yes
    Long term follow-up rationale
    Safety
    Long term follow-up duration
    2 Years
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Norway: 844
    Country: Number of subjects enrolled
    Sweden: 861
    Country: Number of subjects enrolled
    United Kingdom: 8381
    Country: Number of subjects enrolled
    Denmark: 1850
    Country: Number of subjects enrolled
    Finland: 613
    Country: Number of subjects enrolled
    Germany: 1529
    Country: Number of subjects enrolled
    Italy: 1660
    Country: Number of subjects enrolled
    United States: 5330
    Country: Number of subjects enrolled
    Canada: 752
    Country: Number of subjects enrolled
    China: 8629
    Worldwide total number of subjects
    30449
    EEA total number of subjects
    15738
    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)
    13277
    From 65 to 84 years
    16779
    85 years and over
    393

    Subject disposition

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    Recruitment
    Recruitment details
    49,787 participants attended a screening visit after which 38,246 entered the run-in period and subsequently 30,449 were randomized between August 2011 and October 2013.

    Pre-assignment
    Screening details
    Successfully screened participants were entered into a run-in period. Attendees were discouraged from continuing to randomization if it was thought unlikely they would be able to continue attending follow-up visits for at least 4-5years. During run-in participants were issued atorvastatin (1 tablet/day) and placebo anacetrapib (1 tablet/day).

    Period 1
    Period 1 title
    Overall trial (overall period)
    Is this the baseline period?
    Yes
    Allocation method
    Randomised - controlled
    Blinding used
    Double blind
    Roles blinded
    Carer, Assessor, Subject, Investigator, Monitor, Data analyst
    Blinding implementation details
    The trial was placebo controlled. Access to randomized data was available to an unblinded statistician and the Data Monitoring Committee. Lipid results were not accessible during the trial.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    Anacetrapib
    Arm description
    Experimental drug
    Arm type
    Experimental

    Investigational medicinal product name
    Anacetrapib
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    100mg daily

    Arm title
    Placebo
    Arm description
    Placebo anacetrapib
    Arm type
    Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Placebo anacetrapib 100mg daily

    Number of subjects in period 1
    Anacetrapib Placebo
    Started
    15225
    15224
    Completed
    15187
    15186
    Not completed
    38
    38
         Consent withdrawn by subject
    16
    17
         Lost to follow-up
    22
    21

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Anacetrapib
    Reporting group description
    Experimental drug

    Reporting group title
    Placebo
    Reporting group description
    Placebo anacetrapib

    Reporting group values
    Anacetrapib Placebo Total
    Number of subjects
    15225 15224 30449
    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)
    6634 6643 13277
        From 65-84 years
    0 0 0
        85 years and over
    0 0 0
        From 65 to 69 years
    3380 3377 6757
        70 years and over
    5211 5204 10415
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    67 ± 8 67 ± 8 -
    Gender categorical
    Units: Subjects
        Female
    2456 2459 4915
        Male
    12769 12765 25534
    Systolic blood pressure (mmHg)
    Units: Subjects
        < 125
    5678 5760 11438
        ≥ 125 < 140
    4819 4740 9559
        ≥ 140
    4728 4724 9452
    Diastolic blood pressure (mmHg)
    Units: Subjects
        < 75
    5656 5790 11446
        ≥ 75 < 85
    5408 5277 10685
        ≥ 85
    4161 4157 8318
    Region
    Units: Subjects
        Europe
    7863 7875 15738
        North America
    3048 3034 6082
        China
    4314 4315 8629
    Body-mass index (kg/m²)
    The body-mass index is the weight in kilograms divided by the square of the height in meters.
    Units: Subjects
        < 25
    3447 3361 6808
        ≥ 25 < 30
    6949 6995 13944
        ≥ 30
    4829 4868 9697
    LDL cholesterol (mmol/L)
    Units: Subjects
        < 1.4
    5023 5077 10100
        ≥ 1.4 < 1.7
    4529 4582 9111
        ≥ 1.7
    5559 5442 11001
        Missing
    114 123 237
    Non-HDL cholesterol (mmol/L)
    Units: Subjects
        < 2.2
    5642 5701 11343
        ≥ 2.2 < 2.6
    4782 4730 9512
        ≥ 2.6
    4687 4670 9357
        Missing
    114 123 237
    HDL cholesterol (mmol/L)
    Units: Subjects
        < 0.9
    4583 4590 9173
        ≥ 0.9 < 1.1
    5324 5146 10470
        ≥ 1.1
    5204 5365 10569
        Missing
    114 123 237
    Glomerular filtration rate (ml/min/1.73m²)
    The estimated glomerular filtration rate was calculated with the use of the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation.
    Units: Subjects
        < 60
    1655 1698 3353
        ≥ 60
    13570 13526 27096
    Systolic blood pressure
    Units: mm Hg
        arithmetic mean (standard deviation)
    131.3 ± 18.5 131.1 ± 18.5 -
    Diastolic blood pressure
    Units: mm Hg
        arithmetic mean (standard deviation)
    78.1 ± 10.9 78.0 ± 11 -
    Body-mass index
    The body-mass index is the weight in kilograms divided by the square of the height in meters.
    Units: kg/m²
        arithmetic mean (standard deviation)
    28.6 ± 5.0 28.6 ± 5.1 -
    LDL cholesterol
    Units: mmol/L
        arithmetic mean (standard deviation)
    1.58 ± 0.39 1.57 ± 0.39 -
    Non-HDL cholesterol
    Units: mmol/L
        arithmetic mean (standard deviation)
    2.37 ± 0.49 2.37 ± 0.49 -
    HDL cholesterol
    Units: mmol/L
        arithmetic mean (standard deviation)
    1.04 ± 0.25 1.04 ± 0.25 -
    Glomerular filtration rate
    The estimated glomerular filtration rate was calculated with the use of the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI).
    Units: ml/min/1.73m²
        arithmetic mean (standard deviation)
    83 ± 17 83 ± 17 -

    End points

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    End points reporting groups
    Reporting group title
    Anacetrapib
    Reporting group description
    Experimental drug

    Reporting group title
    Placebo
    Reporting group description
    Placebo anacetrapib

    Primary: Major coronary event

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    End point title
    Major coronary event
    End point description
    Primary assessment involves an intention-to-treat comparison among all randomized participants of the effects of allocation to anacetrapib versus placebo on major coronary events (defined as the occurrence of coronary death, myocardial infarction or coronary revascularization procedure) during the scheduled treatment period. Data reported is for first major coronary event.
    End point type
    Primary
    End point timeframe
    Randomized treatment phase during median follow-up period of 4.1years
    End point values
    Anacetrapib Placebo
    Number of subjects analysed
    15225
    15224
    Units: Events
    1640
    1803
    Statistical analysis title
    Major coronary event
    Comparison groups
    Anacetrapib v Placebo
    Number of subjects included in analysis
    30449
    Analysis specification
    Pre-specified
    Analysis type
    other [1]
    P-value
    = 0.004
    Method
    Logrank
    Parameter type
    Rate Ratio
    Point estimate
    0.91
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    0.85
         upper limit
    0.97
    Notes
    [1] - Time to first event

    Secondary: Major atherosclerotic event

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    End point title
    Major atherosclerotic event
    End point description
    Major atherosclerotic events (defined as coronary death, myocardial infarction or presumed ischaemic stroke; the key secondary outcome) Secondary assessments involve intention-to-treat comparisons among all randomized participants of the effects of allocation to anacetrapib versus placebo during the scheduled treatment period.
    End point type
    Secondary
    End point timeframe
    Randomized treatment phase during median follow-up period of 4.1years
    End point values
    Anacetrapib Placebo
    Number of subjects analysed
    15225
    15224
    Units: Events
    1383
    1483
    Statistical analysis title
    Major atherosclerotic events
    Comparison groups
    Anacetrapib v Placebo
    Number of subjects included in analysis
    30449
    Analysis specification
    Pre-specified
    Analysis type
    other [2]
    P-value
    = 0.052
    Method
    Logrank
    Parameter type
    Rate ratio
    Point estimate
    0.93
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    0.86
         upper limit
    1
    Notes
    [2] - Time to first event

    Secondary: Presumed ischaemic stroke

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    End point title
    Presumed ischaemic stroke
    End point description
    Presumed ischaemic stroke (i.e. not known to be haemorrhagic). Secondary assessments involve intention-to-treat comparisons among all randomized participants of the effects of allocation to anacetrapib versus placebo during the scheduled treatment period.
    End point type
    Secondary
    End point timeframe
    Randomized treatment phase during median follow-up period of 4.1years
    End point values
    Anacetrapib Placebo
    Number of subjects analysed
    15225
    15224
    Units: Events
    485
    489
    Statistical analysis title
    Presumed ischaemic stroke
    Comparison groups
    Anacetrapib v Placebo
    Number of subjects included in analysis
    30449
    Analysis specification
    Pre-specified
    Analysis type
    other [3]
    Method
    Parameter type
    Rate ratio
    Point estimate
    0.99
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    0.87
         upper limit
    1.12
    Notes
    [3] - Time to first event In accordance with the data analysis plan, if the outcome of a major atherosclerotic event did not reach significance, there was no hypothesis testing for presumed ischaemic stoke, so no P value is given.

    Secondary: Major vascular event

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    End point title
    Major vascular event
    End point description
    Major vascular events (defined as coronary death, myocardial infarction, coronary revascularization or presumed ischaemic stroke). Secondary assessments involve intention-to-treat comparisons among all randomized participants of the effects of allocation to anacetrapib versus placebo during the scheduled treatment period
    End point type
    Secondary
    End point timeframe
    Randomized treatment phase during median follow-up period of 4.1years
    End point values
    Anacetrapib Placebo
    Number of subjects analysed
    15225
    15224
    Units: Events
    2068
    2214
    Statistical analysis title
    Major vascular event
    Comparison groups
    Anacetrapib v Placebo
    Number of subjects included in analysis
    30449
    Analysis specification
    Pre-specified
    Analysis type
    other [4]
    P-value
    = 0.02
    Method
    Logrank
    Parameter type
    Rate ratio
    Point estimate
    0.93
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    0.88
         upper limit
    0.99
    Notes
    [4] - Time to first event

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Randomized treatment phase during median follow-up period of 4.1years
    Adverse event reporting additional description
    All serious adverse events were reported on the electronic case report form together with non-serious adverse events that were thought to be related to the randomized study treatment (nSARs). Further tabulations of adverse events have been published at http://www.nejm.org/doi/suppl/10.1056/NEJMoa1706444/suppl_file/nejmoa1706444_appendix_2.html
    Assessment type
    Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    MedDRA
    Dictionary version
    14.0
    Reporting groups
    Reporting group title
    Anacetrapib
    Reporting group description
    Experimental drug

    Reporting group title
    Placebo
    Reporting group description
    Placebo anacetrapib

    Serious adverse events
    Anacetrapib Placebo
    Total subjects affected by serious adverse events
         subjects affected / exposed
    8898 / 15225 (58.44%)
    8912 / 15224 (58.54%)
         number of deaths (all causes)
    1122
    1155
         number of deaths resulting from adverse events
    1122
    1155
    Injury, poisoning and procedural complications
    Injury, poisoning and procedural complications
         subjects affected / exposed
    753 / 15225 (4.95%)
    777 / 15224 (5.10%)
         occurrences causally related to treatment / all
    0 / 889
    0 / 918
         deaths causally related to treatment / all
    0 / 26
    0 / 23
    Investigations
    Investigations
         subjects affected / exposed
    1105 / 15225 (7.26%)
    1135 / 15224 (7.46%)
         occurrences causally related to treatment / all
    0 / 1421
    0 / 1419
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac disorders
    Cardiac disorder
         subjects affected / exposed
    2568 / 15225 (16.87%)
    2766 / 15224 (18.17%)
         occurrences causally related to treatment / all
    0 / 4120
    1 / 4280
         deaths causally related to treatment / all
    0 / 263
    0 / 295
    Congenital, familial and genetic disorders
    Congenital, familial and genetic disorders
         subjects affected / exposed
    9 / 15225 (0.06%)
    4 / 15224 (0.03%)
         occurrences causally related to treatment / all
    0 / 9
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Blood and lymphatic system disorders
    Blood and lymphatic system disorders
         subjects affected / exposed
    188 / 15225 (1.23%)
    182 / 15224 (1.20%)
         occurrences causally related to treatment / all
    0 / 219
    0 / 210
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Nervous system disorders
    Nervous system disorder
         subjects affected / exposed
    1399 / 15225 (9.19%)
    1455 / 15224 (9.56%)
         occurrences causally related to treatment / all
    0 / 1789
    0 / 1822
         deaths causally related to treatment / all
    0 / 90
    0 / 97
    Eye disorders
    Eye disorder
         subjects affected / exposed
    204 / 15225 (1.34%)
    232 / 15224 (1.52%)
         occurrences causally related to treatment / all
    0 / 235
    0 / 264
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ear and labyrinth disorders
    Ear and labrinth disorders
         subjects affected / exposed
    114 / 15225 (0.75%)
    91 / 15224 (0.60%)
         occurrences causally related to treatment / all
    0 / 121
    0 / 99
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Gastrointestinal disorder
         subjects affected / exposed
    813 / 15225 (5.34%)
    788 / 15224 (5.18%)
         occurrences causally related to treatment / all
    2 / 1012
    3 / 976
         deaths causally related to treatment / all
    0 / 20
    0 / 20
    Renal and urinary disorders
    Renal and urinary disorders
         subjects affected / exposed
    415 / 15225 (2.73%)
    398 / 15224 (2.61%)
         occurrences causally related to treatment / all
    0 / 516
    3 / 470
         deaths causally related to treatment / all
    0 / 8
    0 / 8
    Skin and subcutaneous tissue disorders
    Skin and subcutaneous tissue disorders
         subjects affected / exposed
    84 / 15225 (0.55%)
    97 / 15224 (0.64%)
         occurrences causally related to treatment / all
    1 / 93
    2 / 109
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Musculoskeletal and connective tissue disorders
         subjects affected / exposed
    438 / 15225 (2.88%)
    432 / 15224 (2.84%)
         occurrences causally related to treatment / all
    2 / 508
    0 / 501
         deaths causally related to treatment / all
    0 / 1
    0 / 1
    Endocrine disorders
    Endocrine disorder
         subjects affected / exposed
    50 / 15225 (0.33%)
    49 / 15224 (0.32%)
         occurrences causally related to treatment / all
    0 / 50
    0 / 51
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Metabolism and nutrition disorders
    Metabolism and nutrition disorders
         subjects affected / exposed
    642 / 15225 (4.22%)
    687 / 15224 (4.51%)
         occurrences causally related to treatment / all
    0 / 774
    0 / 820
         deaths causally related to treatment / all
    0 / 1
    0 / 2
    Infections and infestations
    Infections and infestations
         subjects affected / exposed
    1559 / 15225 (10.24%)
    1537 / 15224 (10.10%)
         occurrences causally related to treatment / all
    0 / 2097
    2 / 2152
         deaths causally related to treatment / all
    0 / 96
    0 / 91
    Vascular disorders
    Vascular disorders
         subjects affected / exposed
    346 / 15225 (2.27%)
    352 / 15224 (2.31%)
         occurrences causally related to treatment / all
    0 / 399
    0 / 393
         deaths causally related to treatment / all
    0 / 18
    0 / 18
    Surgical and medical procedures
    Surgical and medical procedures
         subjects affected / exposed
    3409 / 15225 (22.39%)
    3478 / 15224 (22.85%)
         occurrences causally related to treatment / all
    1 / 5051
    0 / 5241
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
         subjects affected / exposed
    1323 / 15225 (8.69%)
    1295 / 15224 (8.51%)
         occurrences causally related to treatment / all
    0 / 1810
    1 / 1770
         deaths causally related to treatment / all
    0 / 331
    1 / 331
    Immune system disorders
    Immune system disorder
         subjects affected / exposed
    12 / 15225 (0.08%)
    29 / 15224 (0.19%)
         occurrences causally related to treatment / all
    0 / 12
    1 / 29
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Social circumstances
    Social circumstances
         subjects affected / exposed
    501 / 15225 (3.29%)
    516 / 15224 (3.39%)
         occurrences causally related to treatment / all
    0 / 769
    0 / 778
         deaths causally related to treatment / all
    0 / 2
    0 / 0
    General disorders and administration site conditions
    General disorders and administration site conditions
         subjects affected / exposed
    691 / 15225 (4.54%)
    736 / 15224 (4.83%)
         occurrences causally related to treatment / all
    0 / 781
    0 / 838
         deaths causally related to treatment / all
    0 / 203
    0 / 210
    Psychiatric disorders
    Psychiatric disorders
         subjects affected / exposed
    104 / 15225 (0.68%)
    111 / 15224 (0.73%)
         occurrences causally related to treatment / all
    0 / 117
    0 / 124
         deaths causally related to treatment / all
    0 / 5
    0 / 8
    Reproductive system and breast disorders
    Reproductive system and breast disorders
         subjects affected / exposed
    49 / 15225 (0.32%)
    56 / 15224 (0.37%)
         occurrences causally related to treatment / all
    0 / 53
    0 / 59
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Respiratory, thoracic and mediastinal disorders
         subjects affected / exposed
    606 / 15225 (3.98%)
    605 / 15224 (3.97%)
         occurrences causally related to treatment / all
    0 / 791
    1 / 813
         deaths causally related to treatment / all
    0 / 52
    1 / 41
    Hepatobiliary disorders
    Hepatobiliary disorders
         subjects affected / exposed
    217 / 15225 (1.43%)
    238 / 15224 (1.56%)
         occurrences causally related to treatment / all
    2 / 251
    0 / 268
         deaths causally related to treatment / all
    0 / 5
    0 / 9
    Frequency threshold for reporting non-serious adverse events: 0.01%
    Non-serious adverse events
    Anacetrapib Placebo
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    826 / 15225 (5.43%)
    827 / 15224 (5.43%)
    Surgical and medical procedures
    Surgical and medical procedures
         subjects affected / exposed
    3 / 15225 (0.02%)
    1 / 15224 (0.01%)
         occurrences all number
    3
    1
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
         subjects affected / exposed
    1 / 15225 (0.01%)
    0 / 15224 (0.00%)
         occurrences all number
    2
    0
    Immune system disorders
    Immune system disorders
         subjects affected / exposed
    2 / 15225 (0.01%)
    4 / 15224 (0.03%)
         occurrences all number
    2
    4
    Social circumstances
    Social circumstances
         subjects affected / exposed
    0 / 15225 (0.00%)
    1 / 15224 (0.01%)
         occurrences all number
    0
    1
    General disorders and administration site conditions
    General disorders and administration site conditions
         subjects affected / exposed
    31 / 15225 (0.20%)
    33 / 15224 (0.22%)
         occurrences all number
    32
    38
    Psychiatric disorders
    Psychiatric disorders
         subjects affected / exposed
    18 / 15225 (0.12%)
    26 / 15224 (0.17%)
         occurrences all number
    22
    28
    Reproductive system and breast disorders
    Reproductive system and breast disorders
         subjects affected / exposed
    9 / 15225 (0.06%)
    8 / 15224 (0.05%)
         occurrences all number
    9
    8
    Injury, poisoning and procedural complications
    Injury, poisoning and procedural complications
         subjects affected / exposed
    5 / 15225 (0.03%)
    5 / 15224 (0.03%)
         occurrences all number
    6
    5
    Investigations
    Investigations
         subjects affected / exposed
    62 / 15225 (0.41%)
    54 / 15224 (0.35%)
         occurrences all number
    64
    59
    Cardiac disorders
    Cardiac disorders
         subjects affected / exposed
    12 / 15225 (0.08%)
    7 / 15224 (0.05%)
         occurrences all number
    13
    7
    Respiratory, thoracic and mediastinal disorders
    Respiratory, thoracic and mediastinal disorders
         subjects affected / exposed
    27 / 15225 (0.18%)
    31 / 15224 (0.20%)
         occurrences all number
    28
    33
    Blood and lymphatic system disorders
    Blood and lymphatic system disorders
         subjects affected / exposed
    6 / 15225 (0.04%)
    6 / 15224 (0.04%)
         occurrences all number
    6
    6
    Nervous system disorders
    Nervous system disorders
         subjects affected / exposed
    121 / 15225 (0.79%)
    106 / 15224 (0.70%)
         occurrences all number
    134
    112
    Eye disorders
    Eye disorders
         subjects affected / exposed
    4 / 15225 (0.03%)
    11 / 15224 (0.07%)
         occurrences all number
    4
    11
    Ear and labyrinth disorders
    Ear and labyrinth disorders
         subjects affected / exposed
    6 / 15225 (0.04%)
    8 / 15224 (0.05%)
         occurrences all number
    6
    8
    Gastrointestinal disorders
    Gastrointestinal disorders
         subjects affected / exposed
    200 / 15225 (1.31%)
    192 / 15224 (1.26%)
         occurrences all number
    230
    220
    Renal and urinary disorders
    Renal and urinary disorders
         subjects affected / exposed
    9 / 15225 (0.06%)
    9 / 15224 (0.06%)
         occurrences all number
    9
    10
    Hepatobiliary disorders
    Hepatobiliary disorders
         subjects affected / exposed
    4 / 15225 (0.03%)
    4 / 15224 (0.03%)
         occurrences all number
    4
    4
    Skin and subcutaneous tissue disorders
    Skin and subcutaneous tissue disorders
         subjects affected / exposed
    71 / 15225 (0.47%)
    66 / 15224 (0.43%)
         occurrences all number
    76
    69
    Musculoskeletal and connective tissue disorders
    Musculoskeletal and connective tissue disorders
         subjects affected / exposed
    330 / 15225 (2.17%)
    343 / 15224 (2.25%)
         occurrences all number
    413
    427
    Endocrine disorders
    Endocrine disorders
         subjects affected / exposed
    0 / 15225 (0.00%)
    1 / 15224 (0.01%)
         occurrences all number
    0
    1
    Metabolism and nutrition disorders
    Metabolism and nutrition disorders
         subjects affected / exposed
    45 / 15225 (0.30%)
    41 / 15224 (0.27%)
         occurrences all number
    46
    43
    Infections and infestations
    Infections and infestations
         subjects affected / exposed
    30 / 15225 (0.20%)
    31 / 15224 (0.20%)
         occurrences all number
    33
    32

    More information

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    Substantial protocol amendments (globally)

    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    11 Jan 2016
    The Steering Committee agreed the following changes to the protocol: 1. Cancel any formal interim review of efficacy by the Data Monitoring Committee prior to 3 years’ median follow-up. (The interim review of efficacy originally scheduled to take place at 2.5 years after median randomization, was cancelled and has been removed from the protocol; section 2.5.2.2). 2. Revise the secondary assessments (section 2.3.1.2) to: (i) Major atherosclerotic events (defined as coronary death, myocardial infarction or presumed ischaemic stroke; the key secondary outcome); (ii) Presumed ischaemic stroke; and (iii) Major vascular events (defined as coronary death, myocardial infarction, coronary revascularization or presumed ischaemic stroke); 3. Make minor changes to the tertiary assessments (section 2.3.1.4) Power calculations for the new secondary endpoints have been added, based on the number of participants who have been randomized and the blinded event rates observed to date (section 2.4.3). A brief summary of relevant information that has emerged since the study background and rationale (section 1.1) were written has been added (section 1.2). A small number of administrative changes and clarifications have also been made.

    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

    Online references

    http://www.ncbi.nlm.nih.gov/pubmed/28454801
    http://www.ncbi.nlm.nih.gov/pubmed/28847206
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