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    Clinical Trial Results:
    A Multi-Centre, Randomised, Double Blind, Placebo Controlled, Parallel Group Study of TA 8995 in Patients with Mild Dyslipidaemia, Alone and In Combination with Statin Therapy

    Summary
    EudraCT number
    		 2012-005643-24
    Trial protocol
    		 NL   DK  
    Global end of trial date
    14 Jul 2014

    Results information
    Results version number
    		 v1(current)
    This version publication date
    21 Mar 2016
    First version publication date
    30 Jul 2015
    Other versions

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    TA-8995-03
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT01970215
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Xention Ltd
    Sponsor organisation address
    Iconix Park, London Road, Pampisford, Cambridge, United Kingdom, CB22 3EG
    Public contact
    Development, Xention Ltd, +44 1223 493900, info@xention.com
    Scientific contact
    Development, Xention Ltd, +44 1223 493900, info@xention.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
    14 Jul 2014
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    14 Jul 2014
    Global end of trial reached?
    Yes
    Global end of trial date
    14 Jul 2014
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The primary objective of this trial is to evaluate the efficacy of TA 8995, alone and in combination with statin therapy, on the elevation of HDL C and reduction of LDL C following 12 weeks of treatment.
    Protection of trial subjects
    No specific measures other than DSMB
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    15 Aug 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
    Netherlands: 331
    Country: Number of subjects enrolled
    Denmark: 33
    Worldwide total number of subjects
    364
    EEA total number of subjects
    364
    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)
    158
    From 65 to 84 years
    206
    85 years and over
    0

    Subject disposition

    		 Close Top of page
    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 Screening Period - Day -56 or -48 (depending on washout period required) Run-in/Washout Period - Days -49 to -45

    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
    		 Subject, Investigator, Monitor, Data analyst

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Group 1
    Arm description
    		 0mg TA-8995 & Placebo Statin
    Arm type
    		 Placebo

    Investigational medicinal product name
    TA-8995 0mg
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    0mg TA-8995 (placebo) 1 capsule daily with food

    Investigational medicinal product name
    Placebo Statin
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    0mg Statin Placebo 1 capsule daily with food

    Arm title
    		 Group 2
    Arm description
    		 1mg TA-8995 & Placebo Statin
    Arm type
    		 Experimental

    Investigational medicinal product name
    TA-8995 1mg
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    1mg TA-8995 1 capsule daily with food

    Investigational medicinal product name
    Placebo Statin
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    0mg Statin Placebo 1 capsule daily with food

    Arm title
    		 Group 3
    Arm description
    		 2.5mg TA-8995 & Placebo Statin
    Arm type
    		 Experimental

    Investigational medicinal product name
    TA-8995 2.5mg
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    2.5mg TA-8995 1 capsule daily with food

    Investigational medicinal product name
    Placebo Statin
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    0mg Statin Placebo 1 capsule daily with food

    Arm title
    		 Group 4
    Arm description
    		 5mg TA-8995 & Placebo Statin
    Arm type
    		 Experimental

    Investigational medicinal product name
    Placebo Statin
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    0mg Statin Placebo 1 capsule daily with food

    Investigational medicinal product name
    TA-8995 5mg
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    5mg TA-8995 1 capsule daily with food

    Arm title
    		 Group 5
    Arm description
    		 10mg TA-8995 & Placebo Statin
    Arm type
    		 Experimental

    Investigational medicinal product name
    Placebo Statin
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    0mg Statin Placebo 1 capsule daily with food

    Investigational medicinal product name
    TA-8995 10mg
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    10mg TA-8995 1 capsule daily with food

    Arm title
    		 Group 6
    Arm description
    		 0mg TA-8995 & 20mg Atorvastatin
    Arm type
    		 Active comparator

    Investigational medicinal product name
    TA-8995 0mg
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    0mg TA-8995 (placebo) 1 capsule daily with food

    Investigational medicinal product name
    Atorvastatin 20mg
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    20mg Atorvastatin 1 capsule daily with food

    Arm title
    		 Group 7
    Arm description
    		 10mg TA-8995 & 20mg Atorvastatin
    Arm type
    		 Experimental

    Investigational medicinal product name
    TA-8995 10mg
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    10mg TA-8995 1 capsule daily with food

    Investigational medicinal product name
    Atorvastatin 20mg
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    20mg Atorvastatin 1 capsule daily with food

    Arm title
    		 Group 8
    Arm description
    		 0mg TA-8995 & 10mg Rosuvastatin
    Arm type
    		 Active comparator

    Investigational medicinal product name
    TA-8995 0mg
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    0mg TA-8995 (placebo) 1 capsule daily with food

    Investigational medicinal product name
    Rosuvastatin 10mg
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    10mg Rosuvastatin 1 capsule daily with food

    Arm title
    		 Group 9
    Arm description
    		 10mg TA-8995 & 10mg Rosuvastatin
    Arm type
    		 Experimental

    Investigational medicinal product name
    TA-8995 10mg
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    10mg TA-8995 1 capsule daily with food

    Investigational medicinal product name
    Rosuvastatin 10mg
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    10mg Rosuvastatin 1 capsule daily with food

    Number of subjects in period 1
    		Group 1 Group 2 Group 3 Group 4 Group 5 Group 6 Group 7 Group 8 Group 9
    Started
    40
    41
    41
    40
    40
    40
    40
    41
    41
    Completed
    37
    37
    38
    39
    35
    36
    38
    38
    39
    Not completed
    3
    4
    3
    1
    5
    4
    2
    3
    2
         Consent withdrawn by subject
    -
    -
    1
    -
    -
    -
    -
    -
    -
         Physician decision
    -
    -
    -
    -
    -
    1
    -
    -
    -
         Adverse event, non-fatal
    3
    3
    2
    1
    4
    3
    1
    2
    -
         Not known
    -
    1
    -
    -
    1
    -
    -
    1
    2
         Protocol deviation
    -
    -
    -
    -
    -
    -
    1
    -
    -

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Overall Trial
    Reporting group description
    		 -

    Reporting group values
    		 Overall Trial Total
    Number of subjects
    		 364 364
    Age categorical
    Units: Subjects
        In utero
    		 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0
        Newborns (0-27 days)
    		 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0
        Children (2-11 years)
    		 0 0
        Adolescents (12-17 years)
    		 0 0
        Adults (18-64 years)
    		 158 158
        From 65-84 years
    		 206 206
        85 years and over
    		 0 0
    Gender categorical
    Units: Subjects
        Female
    		 67 67
        Male
    		 297 297

    End points

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    End points reporting groups
    Reporting group title
    Group 1
    Reporting group description
    		 0mg TA-8995 & Placebo Statin

    Reporting group title
    Group 2
    Reporting group description
    		 1mg TA-8995 & Placebo Statin

    Reporting group title
    Group 3
    Reporting group description
    		 2.5mg TA-8995 & Placebo Statin

    Reporting group title
    Group 4
    Reporting group description
    		 5mg TA-8995 & Placebo Statin

    Reporting group title
    Group 5
    Reporting group description
    		 10mg TA-8995 & Placebo Statin

    Reporting group title
    Group 6
    Reporting group description
    		 0mg TA-8995 & 20mg Atorvastatin

    Reporting group title
    Group 7
    Reporting group description
    		 10mg TA-8995 & 20mg Atorvastatin

    Reporting group title
    Group 8
    Reporting group description
    		 0mg TA-8995 & 10mg Rosuvastatin

    Reporting group title
    Group 9
    Reporting group description
    		 10mg TA-8995 & 10mg Rosuvastatin

    Primary: % change in HDL-C levels from baseline to week 12

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    End point title
    		 % change in HDL-C levels from baseline to week 12
    End point description
    End point type
    Primary
    End point timeframe
    Baseline to week 12
    End point values
    		 Group 1 Group 2 Group 3 Group 4 Group 5 Group 6 Group 7 Group 8 Group 9
    Number of subjects analysed
    37
    37
    38
    39
    35
    37
    38
    38
    38
    Units: Percentage
        arithmetic mean (standard deviation)
    1.8 ( 10.974 )
    76.04 ( 26.35 )
    122.28 ( 41.391 )
    160.9 ( 42.269 )
    180.64 ( 42.111 )
    1.27 ( 10.941 )
    154.19 ( 48.988 )
    6.16 ( 12.87 )
    159.86 ( 48.097 )
    Statistical analysis title
    		 Mixed Model for Repeated Measures (MMRM)
    Statistical analysis description
    A restricted maximum likelihood mixed model for repeated measures (MMRM) approach was used. Analysis included fixed categorical effects of treatment, visit, and treatment-by-visit interaction, as well as a continuous fixed covariate for baseline HDL-C or LDL-C score.
    Comparison groups
    Group 1 v Group 2 v Group 3 v Group 4 v Group 5 v Group 6 v Group 7 v Group 8 v Group 9
    Number of subjects included in analysis
    337
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 ≤ 0.05
    Method
    		 Mixed models analysis
    Confidence interval

    Primary: % change in LDL-C levels from baseline to week 12

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    End point title
    		 % change in LDL-C levels from baseline to week 12
    End point description
    End point type
    Primary
    End point timeframe
    Baseline to week 12
    End point values
    		 Group 1 Group 2 Group 3 Group 4 Group 5 Group 6 Group 7 Group 8 Group 9
    Number of subjects analysed
    36
    36
    38
    39
    35
    37
    38
    38
    37
    Units: percentage
        arithmetic mean (standard deviation)
    -0.76 ( 11.858 )
    -26.96 ( 13.542 )
    -32.35 ( 16.259 )
    -45.08 ( 14.779 )
    -45.01 ( 15.602 )
    -46.36 ( 12.068 )
    -67.8 ( 11.505 )
    -45.86 ( 10.202 )
    -63.68 ( 9.901 )
    Statistical analysis title
    		 Mixed Model for Repeated Measures (MMRM)
    Statistical analysis description
    A restricted maximum likelihood mixed model for repeated measures (MMRM) approach was used. Analysis included fixed categorical effects of treatment, visit, and treatment-by-visit interaction, as well as a continuous fixed covariate for baseline HDL-C or LDL-C score.
    Comparison groups
    Group 1 v Group 2 v Group 3 v Group 4 v Group 5 v Group 6 v Group 7 v Group 8 v Group 9
    Number of subjects included in analysis
    334
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 ≤ 0.05
    Method
    		 Mixed models analysis
    Confidence interval

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    From informed consent to patients last visit.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    16.0
    Reporting groups
    Reporting group title
    Group 1
    Reporting group description
    		 0mg TA-8995 & Placebo Statin

    Reporting group title
    Group 2
    Reporting group description
    		 1mg TA-8995 & Placebo Statin

    Reporting group title
    Group 3
    Reporting group description
    		 2.5mg TA-8995 & Placebo Statin

    Reporting group title
    Group 4
    Reporting group description
    		 5mg TA-8995 & Placebo Statin

    Reporting group title
    Group 5
    Reporting group description
    		 10mg TA-8995 & Placebo Statin

    Reporting group title
    Group 6
    Reporting group description
    		 0mg TA-8995 & 20mg Atorvastatin

    Reporting group title
    Group 7
    Reporting group description
    		 10mg TA-8995 & 20mg Atorvastatin

    Reporting group title
    Group 8
    Reporting group description
    		 0mg TA-8995 & 10mg Rosuvastatin

    Reporting group title
    Group 9
    Reporting group description
    		 10mg TA-8995 & 10mg Rosuvastatin

    Serious adverse events
    		 Group 1 Group 2 Group 3 Group 4 Group 5 Group 6 Group 7 Group 8 Group 9
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 40 (0.00%)
    0 / 41 (0.00%)
    2 / 41 (4.88%)
    0 / 40 (0.00%)
    2 / 40 (5.00%)
    1 / 40 (2.50%)
    1 / 40 (2.50%)
    1 / 41 (2.44%)
    1 / 41 (2.44%)
         number of deaths (all causes)
    0
    0
    0
    0
    0
    0
    0
    0
    0
         number of deaths resulting from adverse events
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Renal neoplasm
         subjects affected / exposed
    0 / 40 (0.00%)
    0 / 41 (0.00%)
    1 / 41 (2.44%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    0 / 41 (0.00%)
    0 / 41 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Basal cell carcinoma
         subjects affected / exposed
    0 / 40 (0.00%)
    0 / 41 (0.00%)
    0 / 41 (0.00%)
    0 / 40 (0.00%)
    1 / 40 (2.50%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    0 / 41 (0.00%)
    0 / 41 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cholangiocarcinoma
         subjects affected / exposed
    0 / 40 (0.00%)
    0 / 41 (0.00%)
    0 / 41 (0.00%)
    0 / 40 (0.00%)
    1 / 40 (2.50%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    0 / 41 (0.00%)
    0 / 41 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Ovarian cyst
         subjects affected / exposed
    0 / 40 (0.00%)
    0 / 41 (0.00%)
    0 / 41 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    1 / 40 (2.50%)
    0 / 40 (0.00%)
    0 / 41 (0.00%)
    0 / 41 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Chronic lymphocytic leukaemia
         subjects affected / exposed
    0 / 40 (0.00%)
    0 / 41 (0.00%)
    0 / 41 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    1 / 41 (2.44%)
    0 / 41 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cardiac disorders
    Acute myocardial infarction
         subjects affected / exposed
    0 / 40 (0.00%)
    0 / 41 (0.00%)
    0 / 41 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    1 / 40 (2.50%)
    0 / 41 (0.00%)
    0 / 41 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Nervous system disorders
    Transient ischaemic attack
         subjects affected / exposed
    0 / 40 (0.00%)
    0 / 41 (0.00%)
    0 / 41 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    0 / 41 (0.00%)
    1 / 41 (2.44%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Femoral hernia
         subjects affected / exposed
    0 / 40 (0.00%)
    0 / 41 (0.00%)
    1 / 41 (2.44%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    0 / 41 (0.00%)
    0 / 41 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Group 1 Group 2 Group 3 Group 4 Group 5 Group 6 Group 7 Group 8 Group 9
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    32 / 40 (80.00%)
    32 / 41 (78.05%)
    30 / 41 (73.17%)
    32 / 40 (80.00%)
    33 / 40 (82.50%)
    30 / 40 (75.00%)
    28 / 40 (70.00%)
    33 / 41 (80.49%)
    34 / 41 (82.93%)
    Nervous system disorders
    Dizziness
         subjects affected / exposed
    2 / 40 (5.00%)
    3 / 41 (7.32%)
    2 / 41 (4.88%)
    1 / 40 (2.50%)
    1 / 40 (2.50%)
    2 / 40 (5.00%)
    0 / 40 (0.00%)
    0 / 41 (0.00%)
    1 / 41 (2.44%)
         occurrences all number
    2
    3
    2
    1
    1
    2
    0
    0
    1
    Headache
         subjects affected / exposed
    7 / 40 (17.50%)
    3 / 41 (7.32%)
    8 / 41 (19.51%)
    2 / 40 (5.00%)
    8 / 40 (20.00%)
    5 / 40 (12.50%)
    4 / 40 (10.00%)
    5 / 41 (12.20%)
    6 / 41 (14.63%)
         occurrences all number
    7
    3
    8
    2
    8
    5
    4
    5
    6
    General disorders and administration site conditions
    Fatigue
         subjects affected / exposed
    3 / 40 (7.50%)
    0 / 41 (0.00%)
    2 / 41 (4.88%)
    1 / 40 (2.50%)
    2 / 40 (5.00%)
    1 / 40 (2.50%)
    2 / 40 (5.00%)
    1 / 41 (2.44%)
    1 / 41 (2.44%)
         occurrences all number
    3
    0
    2
    1
    2
    1
    2
    1
    1
    Influenza like illness
         subjects affected / exposed
    1 / 40 (2.50%)
    2 / 41 (4.88%)
    3 / 41 (7.32%)
    2 / 40 (5.00%)
    0 / 40 (0.00%)
    2 / 40 (5.00%)
    1 / 40 (2.50%)
    1 / 41 (2.44%)
    1 / 41 (2.44%)
         occurrences all number
    1
    2
    3
    2
    0
    2
    1
    1
    1
    Gastrointestinal disorders
    Abdominal pain upper
         subjects affected / exposed
    0 / 40 (0.00%)
    3 / 41 (7.32%)
    0 / 41 (0.00%)
    4 / 40 (10.00%)
    2 / 40 (5.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    0 / 41 (0.00%)
    0 / 41 (0.00%)
         occurrences all number
    0
    3
    0
    4
    2
    0
    0
    0
    0
    Diarrhoea
         subjects affected / exposed
    1 / 40 (2.50%)
    3 / 41 (7.32%)
    1 / 41 (2.44%)
    1 / 40 (2.50%)
    2 / 40 (5.00%)
    1 / 40 (2.50%)
    4 / 40 (10.00%)
    1 / 41 (2.44%)
    2 / 41 (4.88%)
         occurrences all number
    1
    3
    1
    1
    2
    1
    4
    1
    2
    Toothache
         subjects affected / exposed
    0 / 40 (0.00%)
    0 / 41 (0.00%)
    3 / 41 (7.32%)
    1 / 40 (2.50%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    0 / 41 (0.00%)
    0 / 41 (0.00%)
         occurrences all number
    0
    0
    3
    1
    0
    0
    0
    0
    0
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    1 / 40 (2.50%)
    1 / 41 (2.44%)
    3 / 41 (7.32%)
    2 / 40 (5.00%)
    0 / 40 (0.00%)
    1 / 40 (2.50%)
    0 / 40 (0.00%)
    1 / 41 (2.44%)
    1 / 41 (2.44%)
         occurrences all number
    1
    1
    3
    2
    0
    1
    0
    1
    1
    Skin and subcutaneous tissue disorders
    Pruritus
         subjects affected / exposed
    0 / 40 (0.00%)
    1 / 41 (2.44%)
    3 / 41 (7.32%)
    1 / 40 (2.50%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    1 / 40 (2.50%)
    2 / 41 (4.88%)
    0 / 41 (0.00%)
         occurrences all number
    0
    1
    3
    1
    0
    0
    1
    2
    0
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    1 / 40 (2.50%)
    0 / 41 (0.00%)
    1 / 41 (2.44%)
    1 / 40 (2.50%)
    3 / 40 (7.50%)
    2 / 40 (5.00%)
    1 / 40 (2.50%)
    1 / 41 (2.44%)
    3 / 41 (7.32%)
         occurrences all number
    1
    0
    1
    1
    3
    2
    1
    1
    3
    Back pain
         subjects affected / exposed
    3 / 40 (7.50%)
    1 / 41 (2.44%)
    2 / 41 (4.88%)
    2 / 40 (5.00%)
    2 / 40 (5.00%)
    2 / 40 (5.00%)
    1 / 40 (2.50%)
    1 / 41 (2.44%)
    5 / 41 (12.20%)
         occurrences all number
    3
    1
    2
    2
    2
    2
    1
    1
    5
    Myalgia
         subjects affected / exposed
    2 / 40 (5.00%)
    2 / 41 (4.88%)
    2 / 41 (4.88%)
    4 / 40 (10.00%)
    1 / 40 (2.50%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    1 / 41 (2.44%)
    2 / 41 (4.88%)
         occurrences all number
    2
    2
    2
    4
    1
    0
    0
    1
    2
    Osteoarthritis
         subjects affected / exposed
    0 / 40 (0.00%)
    0 / 41 (0.00%)
    0 / 41 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    1 / 40 (2.50%)
    0 / 40 (0.00%)
    3 / 41 (7.32%)
    0 / 41 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    0
    3
    0
    Infections and infestations
    Influenza
         subjects affected / exposed
    1 / 40 (2.50%)
    2 / 41 (4.88%)
    2 / 41 (4.88%)
    0 / 40 (0.00%)
    4 / 40 (10.00%)
    1 / 40 (2.50%)
    0 / 40 (0.00%)
    2 / 41 (4.88%)
    3 / 41 (7.32%)
         occurrences all number
    1
    2
    2
    0
    4
    1
    0
    2
    3
    Nasopharyngitis
         subjects affected / exposed
    7 / 40 (17.50%)
    9 / 41 (21.95%)
    9 / 41 (21.95%)
    13 / 40 (32.50%)
    8 / 40 (20.00%)
    10 / 40 (25.00%)
    14 / 40 (35.00%)
    7 / 41 (17.07%)
    3 / 41 (7.32%)
         occurrences all number
    7
    9
    9
    13
    8
    10
    14
    7
    3
    Urinary tract infection
         subjects affected / exposed
    0 / 40 (0.00%)
    1 / 41 (2.44%)
    1 / 41 (2.44%)
    0 / 40 (0.00%)
    1 / 40 (2.50%)
    0 / 40 (0.00%)
    1 / 40 (2.50%)
    4 / 41 (9.76%)
    0 / 41 (0.00%)
         occurrences all number
    0
    1
    1
    0
    1
    0
    1
    4
    0

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    02 Aug 2013
    Changes clarified the screening criteria, improved efficiency of the run-in/washout period, and made the safety procedures more robust
    17 Sep 2013
    Changes were made to improve the screening criteria and add the PCSK9 assay as an exploratory efficacy assessment. Changes were made to allow enrollment of women of childbearing potential, including a urine pregnancy test at screening.

    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/26047975
    For support, Contact us.
    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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