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    Clinical Trial Results:
    A randomised placebo controlled trial of rosuvastatin in systemic lupus erythematosus.

    Summary
    EudraCT number
    2006-006214-16
    Trial protocol
    GB  
    Global end of trial date
    16 May 2014

    Results information
    Results version number
    v1(current)
    This version publication date
    01 Jan 2020
    First version publication date
    01 Jan 2020
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    Rosuvastatin
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    NCT01170585
    WHO universal trial number (UTN)
    -
    Sponsors
    Sponsor organisation name
    Imperial College London
    Sponsor organisation address
    South Kensington Campus, London, United Kingdom, SW7 2AZ
    Public contact
    Dudley Pennell, Imperial College London, +44 (0)20 7351 8810, d.pennell@imperial.ac.uk
    Scientific contact
    Dudley Pennell, Imperial College London, +44 (0)20 7351 8810, d.pennell@imperial.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
    Final
    Date of interim/final analysis
    04 May 2015
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    16 May 2014
    Global end of trial reached?
    Yes
    Global end of trial date
    16 May 2014
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To determine whether Crestor will reduce the rate of progression of atherosclerosis in the carotid arteries of patients with systemic lupus erythematosus (SLE).
    Protection of trial subjects
    None
    Background therapy
    -
    Evidence for comparator
    -
    Actual start date of recruitment
    05 Jul 2010
    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
    United Kingdom: 33
    Worldwide total number of subjects
    33
    EEA total number of subjects
    33
    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)
    33
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    Recruitment took place in four London centers - Imperial College Healthcare NHS Trust (Hammersmith, Charing Cross and St Mary's Hospitals), and London Northwest Healthcare NHS Trust (Northwick Park Hospital). The cardiovascular magnetic resonance was performed at the Royal Brompton Hospital at baseline, 1 year and 2 years.

    Pre-assignment
    Screening details
    Thirty-nine patients were consented of whom thirty-three who fulfilled the eligibility criteria and were enrolled and randomised.

    Period 1
    Period 1 title
    year 1
    Is this the baseline period?
    No
    Allocation method
    Randomised - controlled
    Blinding used
    Double blind
    Roles blinded
    Subject, Investigator

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    Placebo
    Arm description
    Participants received placebo
    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
    Daily 1 tablet for 2 years

    Arm title
    Rosuvastatin
    Arm description
    Participants received Rosuvastatin
    Arm type
    Experimental

    Investigational medicinal product name
    Rosuvastatin
    Investigational medicinal product code
    Other name
    Crestor
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    All patients uptitrated from an initial start dose of 5mg to 20mg rosuvastatin. Daily 1 tablet for 2 years

    Number of subjects in period 1
    Placebo Rosuvastatin
    Started
    17
    16
    Completed
    15
    16
    Not completed
    2
    0
         Adverse event, non-fatal
    2
    -
    Period 2
    Period 2 title
    Year 2
    Is this the baseline period?
    Yes [1]
    Allocation method
    Randomised - controlled
    Blinding used
    Double blind
    Roles blinded
    Subject, Investigator

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    Placebo
    Arm description
    Participants received placebo
    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
    Daily 1 tablet for 2 years

    Arm title
    Rosuvastatin
    Arm description
    Participants received Rosuvastatin
    Arm type
    Experimental

    Investigational medicinal product name
    Rosuvastatin
    Investigational medicinal product code
    Other name
    Crestor
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    All patients uptitrated from an initial start dose of 5mg to 20mg rosuvastatin. Daily 1 tablet for 2 years

    Notes
    [1] - Period 1 is not the baseline period. It is expected that period 1 will be the baseline period.
    Justification: Baseline reported for participants who started the 2. period.
    Number of subjects in period 2 [2]
    Placebo Rosuvastatin
    Started
    15
    16
    Completed
    12
    14
    Not completed
    3
    2
         Adverse event, non-fatal
    3
    1
         Consent withdrawn by subject
    -
    1
    Notes
    [2] - The number of subjects reported to be in the baseline period are not the same as the worldwide number enrolled in the trial. It is expected that these numbers will be the same.
    Justification: Baseline reported for participants who started the 2. period.

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Placebo
    Reporting group description
    Participants received placebo

    Reporting group title
    Rosuvastatin
    Reporting group description
    Participants received Rosuvastatin

    Reporting group values
    Placebo Rosuvastatin Total
    Number of subjects
    15 16 31
    Age categorical
    Units: Subjects
        Adults (18-64 years)
    15 16 31
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    44.3 ± 14.4 50.8 ± 12.9 -
    Gender categorical
    Units: Subjects
        Female
    15 14 29
        Male
    0 2 2
    LDL cholesterol
    Units: mmol/L
        arithmetic mean (standard deviation)
    2.57 ± 0.41 2.60 ± 0.56 -

    End points

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    End points reporting groups
    Reporting group title
    Placebo
    Reporting group description
    Participants received placebo

    Reporting group title
    Rosuvastatin
    Reporting group description
    Participants received Rosuvastatin
    Reporting group title
    Placebo
    Reporting group description
    Participants received placebo

    Reporting group title
    Rosuvastatin
    Reporting group description
    Participants received Rosuvastatin

    Primary: Changes in the Bilateral Carotid Artery Total Wall Volume Compared to Baseline

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    End point title
    Changes in the Bilateral Carotid Artery Total Wall Volume Compared to Baseline
    End point description
    End point type
    Primary
    End point timeframe
    Baseline, 1 year and 2 years
    End point values
    Placebo Rosuvastatin Placebo Rosuvastatin
    Number of subjects analysed
    12
    15
    12
    14
    Units: mm^3
        arithmetic mean (confidence interval 95%)
    -83.65 (-159.41 to 7.89)
    -53.35 (-111.86 to 5.16)
    -78.20 (-169.89 to 13.48)
    -64.66 (-136.86 to 7.53)
    Statistical analysis title
    Placebo vs Rosuvastatin in year 1
    Comparison groups
    Placebo v Rosuvastatin
    Number of subjects included in analysis
    27
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.49
    Method
    t-test, 2-sided
    Confidence interval
    Statistical analysis title
    Placebo vs Rosuvastatin in year 2
    Comparison groups
    Placebo v Rosuvastatin
    Number of subjects included in analysis
    26
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.8
    Method
    t-test, 2-sided
    Confidence interval
    Statistical analysis title
    Placebo vs Rosuvastatin with all time points
    Comparison groups
    Placebo v Rosuvastatin v Placebo v Rosuvastatin
    Number of subjects included in analysis
    53
    Analysis specification
    Post-hoc
    Analysis type
    superiority
    P-value
    = 0.42
    Method
    Mixed models analysis
    Confidence interval

    Primary: The Bilateral Carotid Artery Distensibility

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    End point title
    The Bilateral Carotid Artery Distensibility
    End point description
    End point type
    Primary
    End point timeframe
    1 year and 2 years
    End point values
    Placebo Rosuvastatin Placebo Rosuvastatin
    Number of subjects analysed
    12
    16
    12
    15
    Units: percentage
        arithmetic mean (standard deviation)
    23.64 ± 9.76
    18.33 ± 5.07
    21.5 ± 8.02
    18.36 ± 7.39
    Statistical analysis title
    Placebo vs Rosuvastatin in year 1
    Comparison groups
    Placebo v Rosuvastatin
    Number of subjects included in analysis
    28
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.11
    Method
    t-test, 2-sided
    Confidence interval
    Statistical analysis title
    Placebo vs Rosuvastatin in year 2
    Comparison groups
    Placebo v Rosuvastatin
    Number of subjects included in analysis
    27
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.32
    Method
    t-test, 2-sided
    Confidence interval
    Statistical analysis title
    Placebo vs Rosuvastatin all time points
    Comparison groups
    Placebo v Rosuvastatin v Placebo v Rosuvastatin
    Number of subjects included in analysis
    55
    Analysis specification
    Post-hoc
    Analysis type
    superiority
    P-value
    = 0.039
    Method
    Mixed models analysis
    Confidence interval

    Secondary: Correlation of Vascular Findings to Ventricular Ejection Fraction

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    End point title
    Correlation of Vascular Findings to Ventricular Ejection Fraction
    End point description
    End point type
    Secondary
    End point timeframe
    2 year
    End point values
    Placebo Rosuvastatin
    Number of subjects analysed
    12
    14
    Units: correlation to carotid wall volume
        number (not applicable)
    0.39
    0.18
    No statistical analyses for this end point

    Secondary: Correlation of Vascular Findings to Ventricular Mass

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    End point title
    Correlation of Vascular Findings to Ventricular Mass
    End point description
    End point type
    Secondary
    End point timeframe
    2 years
    End point values
    Placebo Rosuvastatin
    Number of subjects analysed
    12
    14
    Units: correlation to carotid wall volume
        number (not applicable)
    0.04
    -0.15
    No statistical analyses for this end point

    Secondary: Changes in LDL-C Lipids From Baseline

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    End point title
    Changes in LDL-C Lipids From Baseline
    End point description
    End point type
    Secondary
    End point timeframe
    1, year, 2 years
    End point values
    Placebo Rosuvastatin Placebo Rosuvastatin
    Number of subjects analysed
    12
    15
    12
    14
    Units: mmol/L
        arithmetic mean (confidence interval 95%)
    -0.08 (-0.38 to 0.22)
    -1.00 (-1.40 to -0.6)
    -0.14 (-0.47 to 0.2)
    -0.61 (-1.06 to -0.16)
    Statistical analysis title
    Placebo vs Rosuvastatin in all time points
    Comparison groups
    Placebo v Rosuvastatin v Placebo v Rosuvastatin
    Number of subjects included in analysis
    53
    Analysis specification
    Post-hoc
    Analysis type
    superiority
    P-value
    = 0.001
    Method
    Mixed models analysis
    Confidence interval

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    2 years
    Assessment type
    Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    MedDRA
    Dictionary version
    10
    Reporting groups
    Reporting group title
    Placebo
    Reporting group description
    -

    Reporting group title
    Rosuvastatin
    Reporting group description
    -

    Serious adverse events
    Placebo Rosuvastatin
    Total subjects affected by serious adverse events
         subjects affected / exposed
    3 / 17 (17.65%)
    4 / 16 (25.00%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    0
    Injury, poisoning and procedural complications
    Cholecystectomy
         subjects affected / exposed
    1 / 17 (5.88%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hip fracture
         subjects affected / exposed
    0 / 17 (0.00%)
    1 / 16 (6.25%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Surgical and medical procedures
    Post-elective surgery bleeding
         subjects affected / exposed
    0 / 17 (0.00%)
    1 / 16 (6.25%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Surgery for severe mitral regurgitation
         subjects affected / exposed
    0 / 17 (0.00%)
    1 / 16 (6.25%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Immune system disorders
    Lupusflare
         subjects affected / exposed
    1 / 17 (5.88%)
    0 / 16 (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
    Costochondiritis
         subjects affected / exposed
    1 / 17 (5.88%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Polyarthritis
         subjects affected / exposed
    1 / 17 (5.88%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    Pneumonia
         subjects affected / exposed
    1 / 17 (5.88%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pericarditis
         subjects affected / exposed
    0 / 17 (0.00%)
    1 / 16 (6.25%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    Placebo Rosuvastatin
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    10 / 17 (58.82%)
    13 / 16 (81.25%)
    General disorders and administration site conditions
    General disorders
         subjects affected / exposed
    10 / 17 (58.82%)
    13 / 16 (81.25%)
         occurrences all number
    26
    36

    More information

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    Substantial protocol amendments (globally)

    Were there any global substantial amendments to the protocol? No

    Interruptions (globally)

    Were there any global interruptions to the trial? No

    Limitations and caveats

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