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SATURN: CRESTOR Athero Imaging Head to Head IVUS Study

Sponsor
AstraZeneca (Industry)
Overall Status
Completed
CT.gov ID
NCT00620542
Collaborator
The Cleveland Clinic (Other)
2,333
Enrollment
195
Locations
4
Arms
41
Duration (Months)
12
Patients Per Site
0.3
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

A 104-week, randomized, double-blind, parallel group, multi-center Phase IIIb study comparing the effects of treatment with rosuvastatin 40 mg or atorvastatin 80 mg on atherosclerotic disease burden as measured by intravascular ultrasound in patients with coronary artery disease.

Condition or Disease Intervention/Treatment Phase
Phase 3

Study Design

Study Type:
Interventional
Actual Enrollment :
2333 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Study of Coronary Atheroma by Intravascular Ultrasound: Effect of Rosuvastatin Versus Atorvastatin (SATURN)
Study Start Date :
Jan 1, 2008
Actual Primary Completion Date :
Jun 1, 2011
Actual Study Completion Date :
Jun 1, 2011

Arms and Interventions

Arm Intervention/Treatment
Experimental: Rosuvastatin 20 mg

Rosuvastatin 20 mg distributed in 2-week run-in period

Drug: Rosuvastatin
capsule, oral, once daily
Other Names:
  • Crestor

    		•
    Active Comparator: Atorvastatin 40 mg

    Atorvastatin 40 mg distributed in 2-week run-in period

    Drug: Atorvastatin
    capsule, oral, one daily
    Other Names:
  • Lipitor

    		•
    Experimental: Rosuvastatin 40 mg

    Rosuvastatin 40 mg distributed in core 2-year study

    Drug: Rosuvastatin
    capsule, oral, once daily
    Other Names:
  • Crestor

    		•
    Active Comparator: Atorvastatin 80 mg

    Atorvastatin 80 mg distributed in core 2-year study

    Drug: Atorvastatin
    capsule, oral, one daily
    Other Names:
  • Lipitor

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Change From Baseline to End of Study (Week 104) in Percent Atheroma Volume (PAV) [End of study (Week 104)]

      Change in PAV computed as PAV(Week 104)-PAV(baseline) where PAV is calculated as: [sum(EEMcsa-LUMENcsa)/sum EEMcsa]*100 where EEMcsa is the cross-sectional area of the external elastic membrane and LUMENcsa is the cross-sectional area of the lumen, as measured by intravascular ultrasound IVUS of a coronary artery in patients with CAD.

    Secondary Outcome Measures

    1. Numbers of Patients Showing Regression in PAV [End of study (Week 104)]

      Regression defined as a change from baseline in PAV < 0

    2. Change From Baseline to End of Study (Week 104) in Total Atheroma Volume (TAV) [End of study (Week 104)]

      Change in TAV, as measured by IVUS, computed as TAV(Week 104)-TAV(baseline) where TAV is the sum(EEMcsa-LUMENcsa)/n. n is the number of cross-sections measured. TAV for each patient is calculated as the average area of atheroma per cross-section multiplied by the median number of cross-sections measured for all patients in the analysis population.

    3. Numbers of Patients Showing Regression in TAV [End of study (Week 104)]

      Regression defined as a change from baseline in TAV < 0

    4. Total Cholesterol Blood Level [104 weeks]

      Time-weighted average is calculated as the lipid value times the number of days since last lipid assessment, summed for all and divided by the number of days from Part B randomization to date of the last lipid evaluation.

    5. LDL-C Blood Level [104 weeks]

      Time-weighted average is calculated as the lipid value times the number of days since last lipid assessment, summed for all and divided by the number of days from Part B randomization to date of the last lipid evaluation.

    6. HDL-C Blood Level [104 weeks]

      Time-weighted average is calculated as the lipid value times the number of days since last lipid assessment, summed for all and divided by the number of days from Part B randomization to date of the last lipid evaluation.

    7. Triglycerides Blood Level [104 weeks]

      Time-weighted average is calculated as the lipid value times the number of days since last lipid assessment, summed for all and divided by the number of days from Part B randomization to date of the last lipid evaluation.

    8. Non-HDL-C Blood Level [104 weeks]

      Time-weighted average is calculated as the lipid value times the number of days since last lipid assessment, summed for all and divided by the number of days from Part B randomization to date of the last lipid evaluation.

    9. LDL-C/HDL-C Blood Level [104 weeks]

      Time-weighted average is calculated as the lipid value times the number of days since last lipid assessment, summed for all and divided by the number of days from Part B randomization to date of the last lipid evaluation.

    10. Total Cholesterol/HDL-C Blood Level [104 weeks]

      Time-weighted average is calculated as the lipid value times the number of days since last lipid assessment, summed for all and divided by the number of days from Part B randomization to date of the last lipid evaluation.

    11. Non-HDL-C/HDL-C Blood Level [104 weeks]

      Time-weighted average is calculated as the lipid value times the number of days since last lipid assessment, summed for all and divided by the number of days from Part B randomization to date of the last lipid evaluation.

    12. Apolipoprotein B Blood Level [104 weeks]

      Time-weighted average is calculated as the lipid value times the number of days since last lipid assessment, summed for all and divided by the number of days from Part B randomization to date of the last lipid evaluation.

    13. Apolipoprotein A-1 Blood Level [104 weeks]

      Time-weighted average is calculated as the lipid value times the number of days since last lipid assessment, summed for all and divided by the number of days from Part B randomization to date of the last lipid evaluation.

    14. Apoliprotein B/Apolipoprotein A-1 Blood Level [104 weeks]

      Time-weighted average is calculated as the lipid value times the number of days since last lipid assessment, summed for all and divided by the number of days from Part B randomization to date of the last lipid evaluation.

    15. VLDL-C During the 104 Week Treatment Period [104 weeks]

      Time-weighted average is calculated as the lipid value times the number of days since last lipid assessment, summed for all and divided by the number of days from Part B randomization to date of the last lipid evaluation.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 75 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Clinical indication for coronary angiography

    • Angiographic evidence of Coronary Artery Disease (CAD), as defined by at least 1 lesion in a native coronary artery that has >20% reduction in lumen diameter by visual estimation

    • Left main coronary artery must have <=50% reduction in lumen diameter by visual estimation

    • LDL-C >100 mg/dL (2.6 mmol/L) for patients with no statin therapy in the past 4 weeks; LDL-C >80mg/dL (2.08mmol/L) for patients on therapy in the past 4 weeks

    Exclusion Criteria:

    • Use of certain lipid-lowering medication for more than 3 months within the previous 12 months. Longer periods of treatment are not permitted because of the potential effects of such therapy on coronary atherosclerosis.

    • Patients who have symptoms consistent with moderate or greater severity of Congestive Heart Failure (CHF).

    • Clinically significant heart disease which, in the opinion of the Principal Investigator (or designee), is likely to require coronary bypass surgery, cardiac transplantation, surgical repair and/or replacement during the course of the study

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Research Site Huntsville Alabama United States
    2 Research Site Los Angeles California United States
    3 Research Site Mountain View California United States
    4 Research Site Sacramento California United States
    5 Research Site San Diego California United States
    6 Research Site Santa Rosa California United States
    7 Research Site Torrance California United States
    8 Research Site Boulder Colorado United States
    9 Research Site Greeley Colorado United States
    10 Research Site Loveland Colorado United States
    11 Research Site Farmington Connecticut United States
    12 Research Site Washington District of Columbia United States
    13 Research Site Clearwater Florida United States
    14 Research Site Ft Lauderdale Florida United States
    15 Research Site Jacksonville Florida United States
    16 Research Site Melbourne Florida United States
    17 Research Site Miami Florida United States
    18 Research Site Orlando Florida United States
    19 Research Site Sarasota Florida United States
    20 Research Site Tampa Florida United States
    21 Research Site Winter Haven Florida United States
    22 Research Site Atlanta Georgia United States
    23 Research Site Augusta Georgia United States
    24 Research Site Elkhart Indiana United States
    25 Research Site Hammond Indiana United States
    26 Research Site Indianapolis Indiana United States
    27 Research Site Merrillville Indiana United States
    28 Research Site Valparaiso Indiana United States
    29 Research Site Davenport Iowa United States
    30 Research Site Iowa City Iowa United States
    31 Research Site West Des Moines Iowa United States
    32 Research Site Ashland Kentucky United States
    33 Research Site Lexington Kentucky United States
    34 Research Site Louisville Kentucky United States
    35 Research Site Covington Louisiana United States
    36 Research Site Bethesda Maryland United States
    37 Research Site Columbia Maryland United States
    38 Research Site Takoma Park Maryland United States
    39 Research Site Bay City Michigan United States
    40 Research Site Grand Blanc Michigan United States
    41 Research Site Kalamazoo Michigan United States
    42 Research Site Midland Michigan United States
    43 Research Site Muskegon Michigan United States
    44 Research Site Petoskey Michigan United States
    45 Research Site Saginaw Michigan United States
    46 Research Site Southfield Michigan United States
    47 Research Site Duluth Minnesota United States
    48 Research Site Minneapolis Minnesota United States
    49 Research Site Rochester Minnesota United States
    50 Research Site St Cloud Minnesota United States
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    53 Research Site Kansas City Missouri United States
    54 Research Site Missoula Montana United States
    55 Research Site Lincoln Nebraska United States
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    60 Research Site Buffalo New York United States
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    64 Research Site Williamsville New York United States
    65 Research Site Charlotte North Carolina United States
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    68 Research Site Fargo North Dakota United States
    69 Research Site Cincinnati Ohio United States
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    73 Research Site Kettering Ohio United States
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    76 Research Site Oklahoma City Oklahoma United States
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    90 Research Site Memphis Tennessee United States
    91 Research Site Oak Ridge Tennessee United States
    92 Research Site Dallas Texas United States
    93 Research Site San Antonio Texas United States
    94 Research Site Charlottesville Virginia United States
    95 Research Site Bellevue Washington United States
    96 Research Site Spokane Washington United States
    97 Research Site Tacoma Washington United States
    98 Research Site Cap. Fed. Buenos Aires Argentina
    99 Research Site Ciudad de Buenos Aires Buenos Aires Argentina
    100 Research Site Rosario Santa Fe-argentina Argentina
    101 Research Site Buenos Aires Argentina
    102 Research Site Cordoba Argentina
    103 Research Site Corrientes Argentina
    104 Research Site Liverpool New South Wales Australia
    105 Research Site New Lambton Heights New South Wales Australia
    106 Research Site Chermside Queensland Australia
    107 Research Site Adelaide South Australia Australia
    108 Research Site Perth Western Australia Australia
    109 Research Site Aalst Belgium
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    112 Research Site Charleroi Belgium
    113 Research Site Genk Belgium
    114 Research Site Leuven Belgium
    115 Research Site Cariacica ES Brazil
    116 Research Site Vitoria ES Brazil
    117 Research Site Goiania GO Brazil
    118 Research Site Uberlandia MG Brazil
    119 Research Site Cuiaba MT Brazil
    120 Research Site Curitiba PR Brazil
    121 Research Site Ribeirao Preto SP Brazil
    122 Research Site Sao Paulo SP Brazil
    123 Research Site Calgary Alberta Canada
    124 Research Site Edmonton Alberta Canada
    125 Research Site Vancouver British Columbia Canada
    126 Research Site Victoria British Columbia Canada
    127 Research Site Winnipeg Manitoba Canada
    128 Research Site Saint John New Brunswick Canada
    129 Research Site Halifax Nova Scotia Canada
    130 Research Site Hamilton Ontario Canada
    131 Research Site London Ontario Canada
    132 Research Site Newmarket Ontario Canada
    133 Research Site Ottawa Ontario Canada
    134 Research Site Toronto Ontario Canada
    135 Research Site Chicoutimi Quebec Canada
    136 Research Site Laval Quebec Canada
    137 Research Site Montreal Quebec Canada
    138 Research Site Saskatoon Saskatchewan Canada
    139 Research Site Quebec Canada
    140 Research Site Besancon France
    141 Research Site Bron France
    142 Research Site Creteil France
    143 Research Site Le Plessis-robinson France
    144 Research Site Marseille France
    145 Research Site Pessac France
    146 Research Site Quincy Sous Senart France
    147 Research Site Strasbourg France
    148 Research Site Toulouse France
    149 Research Site Budapest Hungary
    150 Research Site Szged Hungary
    151 Research Site Arezzo AR Italy
    152 Research Site Sesto San Giovanni Milano Italy
    153 Research Site Milano MI Italy
    154 Research Site Rozzano MI Italy
    155 Research Site Parma PR Italy
    156 Research Site Siena SI Italy
    157 Research Site Udine UD Italy
    158 Research Site Novara Italy
    159 Research Site Roma Italy
    160 Research Site Guadalajara Jalisco Mexico
    161 Research Site Aguascalientes Mexico
    162 Research Site D.F Mexico
    163 Research Site Monterrey Mexico
    164 Research Site Puebla Mexico
    165 Research Site Queretaro Mexico
    166 Research Site Tijuana Mexico
    167 Research Site Alkmaar Netherlands
    168 Research Site Amsterdam Netherlands
    169 Research Site Breda Netherlands
    170 Research Site Eindhoven Netherlands
    171 Research Site Enschede Netherlands
    172 Research Site Leeuwarden Netherlands
    173 Research Site Nieuwegein Netherlands
    174 Research Site Nijmegen Netherlands
    175 Research Site Rotterdam Netherlands
    176 Research Site Zwolle Netherlands
    177 Research Site Bialystok Poland
    178 Research Site Katowice Poland
    179 Research Site Kedzierzyn Kozle Poland
    180 Research Site Krakow Poland
    181 Research Site Lodz Poland
    182 Research Site Poznan Poland
    183 Research Site Warszawa Poland
    184 Research Site Zabrze Poland
    185 Research Site Krasnogorsk Moscow Region Russian Federation
    186 Research Site Moscow Russian Federation
    187 Research Site Saint Petersburg Russian Federation
    188 Research Site Tomsk Russian Federation
    189 Research Site Tumen Russian Federation
    190 Research Site Malaga Andalucia Spain
    191 Research Site Oviedo Asturias Spain
    192 Research Site Badalona Cataluna Spain
    193 Research Site Barcelona Cataluna Spain
    194 Research Site Madrid Comunidad de Madrid Spain
    195 Research Site Alicante Comunidad Valenciana Spain

    Sponsors and Collaborators

    • AstraZeneca
    • The Cleveland Clinic

    Investigators

    • Principal Investigator: Stephen J Nicholls, MBBS, PhD, Cleveland Clinic Foundation, Cardiovascular Medicine

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    AstraZeneca
    ClinicalTrials.gov Identifier:
    NCT00620542
    Other Study ID Numbers:
    • D356IC00001
    • 2007-004000-13
    First Posted:
    Feb 21, 2008
    Last Update Posted:
    Jul 16, 2012
    Last Verified:
    Jul 1, 2012
    Keywords provided by AstraZeneca
    Coronary artery disease
    Additional relevant MeSH terms:
    Atherosclerosis
    Coronary Artery Disease
    Myocardial Ischemia
    Atorvastatin
    Rosuvastatin Calcium

    Study Results

    Participant Flow

    Recruitment Details 2333 Coronary Artery Disease (CAD) patients with clinical indication for coronary angiography were randomized to Part A, the 2-week run-in period. Of these, 1578 patients were treated and 1385 completed Part A. The 1385 patients completing Part A were then randomized to Part B the core study period of 104 weeks of treatment.
    Pre-assignment Detail Angiography was performed to determine if patients were qualified to continue in the study based on protocol-specified angiographic criteria. Patients who satisfied all inclusion and exclusion criteria had an Intravascular Ultrasound (IVUS) performed within 2 weeks of the qualifying angiography.
    Arm/Group Title Rosuvastatin 20 mg Atorvastatin 40 mg Rosuvastatin 40 mg Atorvastatin 80 mg
    Arm/Group Description 2 week run-in period 2 week run-in period 2 year core study 2 year core study
    Period Title: Part A (Run-in - 2 Weeks)
    STARTED 1167 1166 0 0
    Received Treatment 783 795 0 0
    COMPLETED 695 690 0 0
    NOT COMPLETED 472 476 0 0
    Period Title: Part A (Run-in - 2 Weeks)
    STARTED 0 0 694 691
    Received Treatment 0 0 691 689
    Intent-to-treat Population 0 0 520 519
    COMPLETED 0 0 546 547
    NOT COMPLETED 0 0 148 144

    Baseline Characteristics

    Arm/Group Title Rosuvastatin 40 mg Atorvastatin 80 mg Total
    Arm/Group Description 2 years 2 years Total of all reporting groups
    Overall Participants 520 519 1039
    Age (Count of Participants)
    <=18 years
    0
    0%
    0
    0%
    0
    0%
    Between 18 and 65 years
    402
    77.3%
    395
    76.1%
    797
    76.7%
    >=65 years
    118
    22.7%
    124
    23.9%
    242
    23.3%
    Age (years) [Mean (Standard Deviation) ]
    Age (yrs) at Week 0
    57.4
    (8.60)
    57.9
    (8.50)
    57.6
    (8.55)
    Sex: Female, Male (Count of Participants)
    Female
    141
    27.1%
    133
    25.6%
    274
    26.4%
    Male
    379
    72.9%
    386
    74.4%
    765
    73.6%

    Outcome Measures

    1. Primary Outcome
    Title Change From Baseline to End of Study (Week 104) in Percent Atheroma Volume (PAV)
    Description Change in PAV computed as PAV(Week 104)-PAV(baseline) where PAV is calculated as: [sum(EEMcsa-LUMENcsa)/sum EEMcsa]*100 where EEMcsa is the cross-sectional area of the external elastic membrane and LUMENcsa is the cross-sectional area of the lumen, as measured by intravascular ultrasound IVUS of a coronary artery in patients with CAD.
    Time Frame End of study (Week 104)

    Outcome Measure Data

    Analysis Population Description
    Intent-to-Treat population (patients received at least one dose of study drug and had pre-study and post-study IVUS).
    Arm/Group Title Rosuvastatin 40 mg Atorvastatin 80 mg
    Arm/Group Description Part B: Rosuvastatin 40 mg for core study - 2 years Part B: Atorvastatin 80 mg for core study - 2 years
    Measure Participants 520 519
    Median (95% Confidence Interval) [Percent change]
    -1.22
    -0.99
    2. Secondary Outcome
    Title Numbers of Patients Showing Regression in PAV
    Description Regression defined as a change from baseline in PAV < 0
    Time Frame End of study (Week 104)

    Outcome Measure Data

    Analysis Population Description
    Intent-to-Treat population (patients received at least one dose of study drug and had pre-study and post-study IVUS).
    Arm/Group Title Rosuvastatin 40 mg Atorvastatin 80 mg
    Arm/Group Description Part B: Rosuvastatin 40 mg for core study - 2 years Part B: Atorvastatin 80 mg for core study - 2 years
    Measure Participants 520 519
    Number [Participants]
    356
    68.5%
    328
    63.2%
    3. Secondary Outcome
    Title Change From Baseline to End of Study (Week 104) in Total Atheroma Volume (TAV)
    Description Change in TAV, as measured by IVUS, computed as TAV(Week 104)-TAV(baseline) where TAV is the sum(EEMcsa-LUMENcsa)/n. n is the number of cross-sections measured. TAV for each patient is calculated as the average area of atheroma per cross-section multiplied by the median number of cross-sections measured for all patients in the analysis population.
    Time Frame End of study (Week 104)

    Outcome Measure Data

    Analysis Population Description
    Intent-to-Treat population (patients received at least one dose of study drug and had pre-study and post-study IVUS).
    Arm/Group Title Rosuvastatin 40 mg Atorvastatin 80 mg
    Arm/Group Description Part B: Rosuvastatin 40 mg for core study - 2 years Part B: Atorvastatin 80 mg for core study - 2 years
    Measure Participants 520 519
    Median (95% Confidence Interval) [mm^3]
    -6.39
    -4.42
    4. Secondary Outcome
    Title Numbers of Patients Showing Regression in TAV
    Description Regression defined as a change from baseline in TAV < 0
    Time Frame End of study (Week 104)

    Outcome Measure Data

    Analysis Population Description
    Intent-to-Treat population (patients received at least one dose of study drug and had pre-study and post-study IVUS).
    Arm/Group Title Rosuvastatin 40 mg Atorvastatin 80 mg
    Arm/Group Description Part B: Rosuvastatin 40 mg for core study - 2 years Part B: Atorvastatin 80 mg for core study - 2 years
    Measure Participants 520 519
    Number [Participants]
    371
    71.3%
    336
    64.7%
    5. Secondary Outcome
    Title Total Cholesterol Blood Level
    Description Time-weighted average is calculated as the lipid value times the number of days since last lipid assessment, summed for all and divided by the number of days from Part B randomization to date of the last lipid evaluation.
    Time Frame 104 weeks

    Outcome Measure Data

    Analysis Population Description
    Intent-to-Treat population (patients received at least one dose of study drug and had pre-study and post-study IVUS).
    Arm/Group Title Rosuvastatin 40 mg Atorvastatin 80 mg
    Arm/Group Description Part B: Rosuvastatin 40 mg for core study - 2 years Part B: Atorvastatin 80 mg for core study - 2 years
    Measure Participants 519 519
    Least Squares Mean (Standard Error) [mg/dL]
    139.38
    (1.24)
    144.05
    (1.23)
    6. Secondary Outcome
    Title LDL-C Blood Level
    Description Time-weighted average is calculated as the lipid value times the number of days since last lipid assessment, summed for all and divided by the number of days from Part B randomization to date of the last lipid evaluation.
    Time Frame 104 weeks

    Outcome Measure Data

    Analysis Population Description
    Intent-to-Treat population (patients received at least one dose of study drug and had pre-study and post-study IVUS).
    Arm/Group Title Rosuvastatin 40 mg Atorvastatin 80 mg
    Arm/Group Description Part B: Rosuvastatin 40 mg for core study - 2 years Part B: Atorvastatin 80 mg for core study - 2 years
    Measure Participants 519 519
    Least Squares Mean (Standard Error) [mg/dL]
    62.64
    (1.00)
    70.18
    (0.99)
    7. Secondary Outcome
    Title HDL-C Blood Level
    Description Time-weighted average is calculated as the lipid value times the number of days since last lipid assessment, summed for all and divided by the number of days from Part B randomization to date of the last lipid evaluation.
    Time Frame 104 weeks

    Outcome Measure Data

    Analysis Population Description
    Intent-to-Treat population (patients received at least one dose of study drug and had pre-study and post-study IVUS).
    Arm/Group Title Rosuvastatin 40 mg Atorvastatin 80 mg
    Arm/Group Description Part B: Rosuvastatin 40 mg for core study - 2 years Part B: Atorvastatin 80 mg for core study - 2 years
    Measure Participants 519 519
    Least Squares Mean (Standard Error) [mg/dL]
    50.43
    (0.54)
    48.64
    (0.53)
    8. Secondary Outcome
    Title Triglycerides Blood Level
    Description Time-weighted average is calculated as the lipid value times the number of days since last lipid assessment, summed for all and divided by the number of days from Part B randomization to date of the last lipid evaluation.
    Time Frame 104 weeks

    Outcome Measure Data

    Analysis Population Description
    Intent-to-Treat population (patients received at least one dose of study drug and had pre-study and post-study IVUS).
    Arm/Group Title Rosuvastatin 40 mg Atorvastatin 80 mg
    Arm/Group Description Part B: Rosuvastatin 40 mg for core study - 2 years Part B: Atorvastatin 80 mg for core study - 2 years
    Measure Participants 519 519
    Least Squares Mean (Standard Error) [mg/dL]
    132.50
    (2.44)
    126.58
    (2.43)
    9. Secondary Outcome
    Title Non-HDL-C Blood Level
    Description Time-weighted average is calculated as the lipid value times the number of days since last lipid assessment, summed for all and divided by the number of days from Part B randomization to date of the last lipid evaluation.
    Time Frame 104 weeks

    Outcome Measure Data

    Analysis Population Description
    Intent-to-Treat population (patients received at least one dose of study drug and had pre-study and post-study IVUS).
    Arm/Group Title Rosuvastatin 40 mg Atorvastatin 80 mg
    Arm/Group Description Part B: Rosuvastatin 40 mg for core study - 2 years Part B: Atorvastatin 80 mg for core study - 2 years
    Measure Participants 519 519
    Least Squares Mean (Standard Error) [mg/dL]
    88.95
    (1.15)
    95.41
    (1.14)
    10. Secondary Outcome
    Title LDL-C/HDL-C Blood Level
    Description Time-weighted average is calculated as the lipid value times the number of days since last lipid assessment, summed for all and divided by the number of days from Part B randomization to date of the last lipid evaluation.
    Time Frame 104 weeks

    Outcome Measure Data

    Analysis Population Description
    Intent-to-Treat population (patients received at least one dose of study drug and had pre-study and post-study IVUS).
    Arm/Group Title Rosuvastatin 40 mg Atorvastatin 80 mg
    Arm/Group Description Part B: Rosuvastatin 40 mg for core study - 2 years Part B: Atorvastatin 80 mg for core study - 2 years
    Measure Participants 519 519
    Least Squares Mean (Standard Error) [Ratio]
    1.30
    (0.02)
    1.50
    (0.02)
    11. Secondary Outcome
    Title Total Cholesterol/HDL-C Blood Level
    Description Time-weighted average is calculated as the lipid value times the number of days since last lipid assessment, summed for all and divided by the number of days from Part B randomization to date of the last lipid evaluation.
    Time Frame 104 weeks

    Outcome Measure Data

    Analysis Population Description
    Intent-to-Treat population (patients received at least one dose of study drug and had pre-study and post-study IVUS).
    Arm/Group Title Rosuvastatin 40 mg Atorvastatin 80 mg
    Arm/Group Description Part B: Rosuvastatin 40 mg for core study - 2 years Part B: Atorvastatin 80 mg for core study - 2 years
    Measure Participants 519 519
    Least Squares Mean (Standard Error) [Ratio]
    2.88
    (0.03)
    3.08
    (0.03)
    12. Secondary Outcome
    Title Non-HDL-C/HDL-C Blood Level
    Description Time-weighted average is calculated as the lipid value times the number of days since last lipid assessment, summed for all and divided by the number of days from Part B randomization to date of the last lipid evaluation.
    Time Frame 104 weeks

    Outcome Measure Data

    Analysis Population Description
    Intent-to-Treat population (patients received at least one dose of study drug and had pre-study and post-study IVUS).
    Arm/Group Title Rosuvastatin 40 mg Atorvastatin 80 mg
    Arm/Group Description Part B: Rosuvastatin 40 mg for core study - 2 years Part B: Atorvastatin 80 mg for core study - 2 years
    Measure Participants 519 519
    Least Squares Mean (Standard Error) [Ratio]
    1.88
    (0.03)
    2.08
    (0.03)
    13. Secondary Outcome
    Title Apolipoprotein B Blood Level
    Description Time-weighted average is calculated as the lipid value times the number of days since last lipid assessment, summed for all and divided by the number of days from Part B randomization to date of the last lipid evaluation.
    Time Frame 104 weeks

    Outcome Measure Data

    Analysis Population Description
    Intent-to-Treat population (patients received at least one dose of study drug and had pre-study and post-study IVUS).
    Arm/Group Title Rosuvastatin 40 mg Atorvastatin 80 mg
    Arm/Group Description Part B: Rosuvastatin 40 mg for core study - 2 years Part B: Atorvastatin 80 mg for core study - 2 years
    Measure Participants 518 519
    Least Squares Mean (Standard Error) [mg/dL]
    72.55
    (0.85)
    75.12
    (0.85)
    14. Secondary Outcome
    Title Apolipoprotein A-1 Blood Level
    Description Time-weighted average is calculated as the lipid value times the number of days since last lipid assessment, summed for all and divided by the number of days from Part B randomization to date of the last lipid evaluation.
    Time Frame 104 weeks

    Outcome Measure Data

    Analysis Population Description
    Intent-to-Treat population (patients received at least one dose of study drug and had pre-study and post-study IVUS).
    Arm/Group Title Rosuvastatin 40 mg Atorvastatin 80 mg
    Arm/Group Description Part B: Rosuvastatin 40 mg for core study - 2 years Part B: Atorvastatin 80 mg for core study - 2 years
    Measure Participants 518 519
    Least Squares Mean (Standard Error) [mg/dL]
    146.81
    (1.03)
    137.68
    (1.02)
    15. Secondary Outcome
    Title Apoliprotein B/Apolipoprotein A-1 Blood Level
    Description Time-weighted average is calculated as the lipid value times the number of days since last lipid assessment, summed for all and divided by the number of days from Part B randomization to date of the last lipid evaluation.
    Time Frame 104 weeks

    Outcome Measure Data

    Analysis Population Description
    Intent-to-Treat population (patients received at least one dose of study drug and had pre-study and post-study IVUS).
    Arm/Group Title Rosuvastatin 40 mg Atorvastatin 80 mg
    Arm/Group Description Part B: Rosuvastatin 40 mg for core study - 2 years Part B: Atorvastatin 80 mg for core study - 2 years
    Measure Participants 518 519
    Least Squares Mean (Standard Error) [Ratio]
    0.51
    (0.01)
    0.56
    (0.01)
    16. Secondary Outcome
    Title VLDL-C During the 104 Week Treatment Period
    Description Time-weighted average is calculated as the lipid value times the number of days since last lipid assessment, summed for all and divided by the number of days from Part B randomization to date of the last lipid evaluation.
    Time Frame 104 weeks

    Outcome Measure Data

    Analysis Population Description
    Intent-to-Treat population (patients received at least one dose of study drug and had pre-study and post-study IVUS).
    Arm/Group Title Rosuvastatin 40 mg Atorvastatin 80 mg
    Arm/Group Description Part B: Rosuvastatin 40 mg for core study - 2 years Part B: Atorvastatin 80 mg for core study - 2 years
    Measure Participants 519 519
    Least Squares Mean (Standard Error) [mg/dL]
    26.05
    (0.45)
    25.03
    (0.44)

    Adverse Events

    Time Frame
    Adverse Event Reporting Description
    Arm/Group Title Rosuvastatin 20 mg Atorvastatin 40 mg Rosuvastatin 40 mg Atorvastatin 80 mg
    Arm/Group Description 2 week run-in period 2 week run-in period 2 year core study 2 year core study
    All Cause Mortality
    Rosuvastatin 20 mg Atorvastatin 40 mg Rosuvastatin 40 mg Atorvastatin 80 mg
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total / (NaN) / (NaN) / (NaN) / (NaN)
    Serious Adverse Events
    Rosuvastatin 20 mg Atorvastatin 40 mg Rosuvastatin 40 mg Atorvastatin 80 mg
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 21/783 (2.7%) 25/795 (3.1%) 194/691 (28.1%) 168/689 (24.4%)
    Blood and lymphatic system disorders
    Anaemia 0/783 (0%) 0/795 (0%) 1/691 (0.1%) 2/689 (0.3%)
    Iron Deficiency Anaemia 0/783 (0%) 0/795 (0%) 1/691 (0.1%) 0/689 (0%)
    Cardiac disorders
    Angina Pectoris 5/783 (0.6%) 5/795 (0.6%) 25/691 (3.6%) 28/689 (4.1%)
    Angina Unstable 0/783 (0%) 2/795 (0.3%) 17/691 (2.5%) 11/689 (1.6%)
    Coronary Artery Stenosis 1/783 (0.1%) 0/795 (0%) 12/691 (1.7%) 9/689 (1.3%)
    Coronary Artery Disease 0/783 (0%) 0/795 (0%) 10/691 (1.4%) 4/689 (0.6%)
    Acute Myocardial Infarction 0/783 (0%) 1/795 (0.1%) 5/691 (0.7%) 6/689 (0.9%)
    Atrial Fibrillation 0/783 (0%) 1/795 (0.1%) 3/691 (0.4%) 6/689 (0.9%)
    Myocardial Infarction 1/783 (0.1%) 0/795 (0%) 5/691 (0.7%) 3/689 (0.4%)
    Mitral Valve Incompetence 0/783 (0%) 0/795 (0%) 3/691 (0.4%) 0/689 (0%)
    Palpitations 0/783 (0%) 0/795 (0%) 0/691 (0%) 3/689 (0.4%)
    Acute Coronary Syndrome 1/783 (0.1%) 0/795 (0%) 2/691 (0.3%) 2/689 (0.3%)
    Bradycardia 0/783 (0%) 2/795 (0.3%) 1/691 (0.1%) 2/689 (0.3%)
    Myocardial Ischaemia 0/783 (0%) 0/795 (0%) 2/691 (0.3%) 0/689 (0%)
    Sick Sinus Syndrome 0/783 (0%) 0/795 (0%) 1/691 (0.1%) 2/689 (0.3%)
    Arteriosclerosis Coronary Artery 0/783 (0%) 0/795 (0%) 1/691 (0.1%) 1/689 (0.1%)
    Atrial Flutter 0/783 (0%) 0/795 (0%) 0/691 (0%) 1/689 (0.1%)
    Cardiac Failure 0/783 (0%) 0/795 (0%) 1/691 (0.1%) 0/689 (0%)
    Cardiac Failure Congestive 1/783 (0.1%) 0/795 (0%) 0/691 (0%) 1/689 (0.1%)
    Cardiomyopathy 0/783 (0%) 0/795 (0%) 0/691 (0%) 1/689 (0.1%)
    Coronary Artery Insufficiency 0/783 (0%) 0/795 (0%) 1/691 (0.1%) 0/689 (0%)
    Coronary Artery Occlusion 0/783 (0%) 0/795 (0%) 1/691 (0.1%) 0/689 (0%)
    Coronary Artery Thrombosis 0/783 (0%) 0/795 (0%) 1/691 (0.1%) 0/689 (0%)
    Ischaemic Cardiomyopathy 0/783 (0%) 0/795 (0%) 1/691 (0.1%) 0/689 (0%)
    Pericardial Rub 0/783 (0%) 0/795 (0%) 0/691 (0%) 1/689 (0.1%)
    Pericarditis 1/783 (0.1%) 0/795 (0%) 1/691 (0.1%) 1/689 (0.1%)
    Sinus Arrest 0/783 (0%) 0/795 (0%) 1/691 (0.1%) 0/689 (0%)
    Wolff-Parkinson-White Syndrome 0/783 (0%) 0/795 (0%) 0/691 (0%) 1/689 (0.1%)
    Congenital, familial and genetic disorders
    Congenital Coronary Artery Malformation 0/783 (0%) 0/795 (0%) 1/691 (0.1%) 0/689 (0%)
    Hip Dysplasia 0/783 (0%) 0/795 (0%) 0/691 (0%) 1/689 (0.1%)
    Ear and labyrinth disorders
    Vertigo 0/783 (0%) 0/795 (0%) 0/691 (0%) 2/689 (0.3%)
    Vertigo Positional 0/783 (0%) 0/795 (0%) 0/691 (0%) 1/689 (0.1%)
    Endocrine disorders
    Basedow's Disease 0/783 (0%) 0/795 (0%) 1/691 (0.1%) 0/689 (0%)
    Eye disorders
    Cataract 0/783 (0%) 0/795 (0%) 1/691 (0.1%) 0/689 (0%)
    Retinal Detachment 0/783 (0%) 0/795 (0%) 1/691 (0.1%) 0/689 (0%)
    Gastrointestinal disorders
    Gastrointestinal Haemorrhage 0/783 (0%) 0/795 (0%) 4/691 (0.6%) 0/689 (0%)
    Abdominal Pain 1/783 (0.1%) 0/795 (0%) 2/691 (0.3%) 1/689 (0.1%)
    Abdominal Pain Lower 0/783 (0%) 0/795 (0%) 2/691 (0.3%) 0/689 (0%)
    Abdominal Pain Upper 0/783 (0%) 0/795 (0%) 0/691 (0%) 2/689 (0.3%)
    Inguinal Hernia 0/783 (0%) 0/795 (0%) 1/691 (0.1%) 2/689 (0.3%)
    Pancreatitis 0/783 (0%) 0/795 (0%) 0/691 (0%) 2/689 (0.3%)
    Colitis 0/783 (0%) 0/795 (0%) 0/691 (0%) 1/689 (0.1%)
    Colitis Ulcerative 0/783 (0%) 0/795 (0%) 0/691 (0%) 1/689 (0.1%)
    Colonic Polyp 0/783 (0%) 0/795 (0%) 1/691 (0.1%) 1/689 (0.1%)
    Constipation 0/783 (0%) 0/795 (0%) 0/691 (0%) 1/689 (0.1%)
    Diarrhoea 0/783 (0%) 0/795 (0%) 0/691 (0%) 1/689 (0.1%)
    Enteritis 0/783 (0%) 0/795 (0%) 1/691 (0.1%) 0/689 (0%)
    Erosive Oesophagitis 0/783 (0%) 0/795 (0%) 1/691 (0.1%) 0/689 (0%)
    Gastric Polyps 0/783 (0%) 0/795 (0%) 1/691 (0.1%) 0/689 (0%)
    Gastric Ulcer 0/783 (0%) 0/795 (0%) 1/691 (0.1%) 0/689 (0%)
    Gastritis 0/783 (0%) 0/795 (0%) 0/691 (0%) 1/689 (0.1%)
    Haematemesis 0/783 (0%) 0/795 (0%) 0/691 (0%) 1/689 (0.1%)
    Ileus 0/783 (0%) 0/795 (0%) 1/691 (0.1%) 0/689 (0%)
    Nausea 0/783 (0%) 0/795 (0%) 0/691 (0%) 1/689 (0.1%)
    Oesophagitis 0/783 (0%) 0/795 (0%) 1/691 (0.1%) 0/689 (0%)
    Retroperitoneal Haematoma 0/783 (0%) 1/795 (0.1%) 1/691 (0.1%) 0/689 (0%)
    Retroperitoneal Haemorrhage 0/783 (0%) 0/795 (0%) 1/691 (0.1%) 0/689 (0%)
    Umbilical Hernia, Obstructive 0/783 (0%) 0/795 (0%) 1/691 (0.1%) 0/689 (0%)
    Upper Gastrointestinal Haemorrhage 0/783 (0%) 0/795 (0%) 0/691 (0%) 1/689 (0.1%)
    General disorders
    Non-Cardiac Chest Pain 1/783 (0.1%) 3/795 (0.4%) 14/691 (2%) 7/689 (1%)
    Chest Pain 0/783 (0%) 0/795 (0%) 7/691 (1%) 7/689 (1%)
    Chest Discomfort 0/783 (0%) 0/795 (0%) 1/691 (0.1%) 0/689 (0%)
    Device Malfunction 0/783 (0%) 0/795 (0%) 1/691 (0.1%) 0/689 (0%)
    Device Occlusion 0/783 (0%) 0/795 (0%) 1/691 (0.1%) 0/689 (0%)
    Device Stimulation Issue 0/783 (0%) 0/795 (0%) 1/691 (0.1%) 0/689 (0%)
    Hernia Pain 0/783 (0%) 0/795 (0%) 1/691 (0.1%) 0/689 (0%)
    Pyrexia 0/783 (0%) 0/795 (0%) 1/691 (0.1%) 0/689 (0%)
    Sudden Death 0/783 (0%) 0/795 (0%) 0/691 (0%) 1/689 (0.1%)
    Thrombosis In Device 1/783 (0.1%) 0/795 (0%) 0/691 (0%) 0/689 (0%)
    Hepatobiliary disorders
    Cholelithiasis 0/783 (0%) 0/795 (0%) 4/691 (0.6%) 1/689 (0.1%)
    Cholecystitis 0/783 (0%) 0/795 (0%) 0/691 (0%) 1/689 (0.1%)
    Cholecystitis Acute 0/783 (0%) 0/795 (0%) 1/691 (0.1%) 1/689 (0.1%)
    Jaundice 0/783 (0%) 0/795 (0%) 1/691 (0.1%) 0/689 (0%)
    Infections and infestations
    Pneumonia 0/783 (0%) 1/795 (0.1%) 4/691 (0.6%) 2/689 (0.3%)
    Urinary Tract Infection 0/783 (0%) 0/795 (0%) 3/691 (0.4%) 2/689 (0.3%)
    Gastroenteritis 1/783 (0.1%) 0/795 (0%) 0/691 (0%) 2/689 (0.3%)
    Urosepsis 0/783 (0%) 0/795 (0%) 2/691 (0.3%) 0/689 (0%)
    Appendicitis 0/783 (0%) 0/795 (0%) 1/691 (0.1%) 1/689 (0.1%)
    Appendicitis Perforated 0/783 (0%) 0/795 (0%) 1/691 (0.1%) 0/689 (0%)
    Arthritis Bacterial 0/783 (0%) 0/795 (0%) 1/691 (0.1%) 0/689 (0%)
    Bronchitis 0/783 (0%) 0/795 (0%) 1/691 (0.1%) 0/689 (0%)
    Cellulitis 0/783 (0%) 0/795 (0%) 1/691 (0.1%) 1/689 (0.1%)
    Dengue Fever 0/783 (0%) 0/795 (0%) 1/691 (0.1%) 0/689 (0%)
    Groin Infection 0/783 (0%) 1/795 (0.1%) 0/691 (0%) 0/689 (0%)
    Herpes Zoster Infection Neurological 0/783 (0%) 0/795 (0%) 1/691 (0.1%) 0/689 (0%)
    Lower Respiratory Tract Infection 0/783 (0%) 0/795 (0%) 1/691 (0.1%) 1/689 (0.1%)
    Pilonidal Cyst 0/783 (0%) 0/795 (0%) 1/691 (0.1%) 0/689 (0%)
    Puncture Site Infection 0/783 (0%) 1/795 (0.1%) 0/691 (0%) 0/689 (0%)
    Staphylococcal Abscess 0/783 (0%) 0/795 (0%) 1/691 (0.1%) 0/689 (0%)
    Upper Respiratory Tract Infection 0/783 (0%) 0/795 (0%) 0/691 (0%) 1/689 (0.1%)
    Injury, poisoning and procedural complications
    In-Stent Coronary Artery Restenosis 0/783 (0%) 0/795 (0%) 6/691 (0.9%) 3/689 (0.4%)
    Ankle Fracture 0/783 (0%) 0/795 (0%) 2/691 (0.3%) 1/689 (0.1%)
    Toxicity To Various Agents 0/783 (0%) 0/795 (0%) 2/691 (0.3%) 0/689 (0%)
    Coronary Artery Restenosis 0/783 (0%) 0/795 (0%) 1/691 (0.1%) 1/689 (0.1%)
    Fall 0/783 (0%) 0/795 (0%) 0/691 (0%) 1/689 (0.1%)
    Femur Fracture 0/783 (0%) 0/795 (0%) 0/691 (0%) 1/689 (0.1%)
    Fractured Coccyx 0/783 (0%) 0/795 (0%) 1/691 (0.1%) 0/689 (0%)
    Hand Fracture 0/783 (0%) 0/795 (0%) 1/691 (0.1%) 0/689 (0%)
    Head Injury 0/783 (0%) 0/795 (0%) 1/691 (0.1%) 1/689 (0.1%)
    Heat Exhaustion 0/783 (0%) 0/795 (0%) 0/691 (0%) 1/689 (0.1%)
    In-Stent Arterial Restenosis 0/783 (0%) 0/795 (0%) 0/691 (0%) 1/689 (0.1%)
    Injury 0/783 (0%) 0/795 (0%) 0/691 (0%) 1/689 (0.1%)
    Intentional Overdose 0/783 (0%) 0/795 (0%) 0/691 (0%) 1/689 (0.1%)
    Joint Dislocation 0/783 (0%) 0/795 (0%) 1/691 (0.1%) 0/689 (0%)
    Laceration 0/783 (0%) 0/795 (0%) 0/691 (0%) 1/689 (0.1%)
    Limb Injury 0/783 (0%) 0/795 (0%) 1/691 (0.1%) 0/689 (0%)
    Lower Limb Fracture 0/783 (0%) 0/795 (0%) 1/691 (0.1%) 0/689 (0%)
    Overdose 0/783 (0%) 1/795 (0.1%) 0/691 (0%) 0/689 (0%)
    Pelvic Fracture 0/783 (0%) 0/795 (0%) 1/691 (0.1%) 0/689 (0%)
    Post Procedural Haemorrhage 0/783 (0%) 0/795 (0%) 1/691 (0.1%) 0/689 (0%)
    Post Procedural Myocardial Infarction 0/783 (0%) 1/795 (0.1%) 0/691 (0%) 0/689 (0%)
    Pseudomeningocele 0/783 (0%) 0/795 (0%) 0/691 (0%) 1/689 (0.1%)
    Road Traffic Accident 0/783 (0%) 0/795 (0%) 1/691 (0.1%) 0/689 (0%)
    Thermal Burn 0/783 (0%) 0/795 (0%) 0/691 (0%) 1/689 (0.1%)
    Traumatic Lung Injury 0/783 (0%) 0/795 (0%) 1/691 (0.1%) 0/689 (0%)
    Investigations
    Blood Pressure Increased 0/783 (0%) 0/795 (0%) 0/691 (0%) 2/689 (0.3%)
    Cardiac Stress Test Abnormal 1/783 (0.1%) 0/795 (0%) 0/691 (0%) 0/689 (0%)
    Heart Rate Irregular 0/783 (0%) 0/795 (0%) 1/691 (0.1%) 0/689 (0%)
    Liver Function Test Abnormal 0/783 (0%) 0/795 (0%) 0/691 (0%) 1/689 (0.1%)
    Occult Blood Positive 0/783 (0%) 0/795 (0%) 1/691 (0.1%) 0/689 (0%)
    Transaminases Increased 0/783 (0%) 0/795 (0%) 0/691 (0%) 1/689 (0.1%)
    Metabolism and nutrition disorders
    Diabetes Mellitus 0/783 (0%) 0/795 (0%) 2/691 (0.3%) 0/689 (0%)
    Hypoglycaemia 0/783 (0%) 0/795 (0%) 1/691 (0.1%) 2/689 (0.3%)
    Hyperglycaemia 0/783 (0%) 0/795 (0%) 0/691 (0%) 1/689 (0.1%)
    Obesity 0/783 (0%) 0/795 (0%) 1/691 (0.1%) 1/689 (0.1%)
    Type 2 Diabetes Mellitus 0/783 (0%) 0/795 (0%) 0/691 (0%) 1/689 (0.1%)
    Musculoskeletal and connective tissue disorders
    Osteoarthritis 0/783 (0%) 0/795 (0%) 6/691 (0.9%) 2/689 (0.3%)
    Musculoskeletal Chest Pain 1/783 (0.1%) 0/795 (0%) 4/691 (0.6%) 0/689 (0%)
    Myalgia 0/783 (0%) 0/795 (0%) 1/691 (0.1%) 3/689 (0.4%)
    Bone Pain 0/783 (0%) 0/795 (0%) 0/691 (0%) 2/689 (0.3%)
    Intervertebral Disc Protrusion 0/783 (0%) 0/795 (0%) 2/691 (0.3%) 0/689 (0%)
    Rotator Cuff Syndrome 0/783 (0%) 0/795 (0%) 2/691 (0.3%) 0/689 (0%)
    Arthralgia 0/783 (0%) 0/795 (0%) 1/691 (0.1%) 1/689 (0.1%)
    Back Pain 0/783 (0%) 0/795 (0%) 1/691 (0.1%) 1/689 (0.1%)
    Bone Loss 0/783 (0%) 0/795 (0%) 0/691 (0%) 1/689 (0.1%)
    Floating Patella 0/783 (0%) 0/795 (0%) 1/691 (0.1%) 0/689 (0%)
    Foot Deformity 0/783 (0%) 0/795 (0%) 0/691 (0%) 1/689 (0.1%)
    Groin Pain 0/783 (0%) 0/795 (0%) 1/691 (0.1%) 0/689 (0%)
    Intervertebral Disc Disorder 0/783 (0%) 0/795 (0%) 0/691 (0%) 1/689 (0.1%)
    Muscle Spasms 0/783 (0%) 1/795 (0.1%) 0/691 (0%) 0/689 (0%)
    Musculoskeletal Pain 0/783 (0%) 0/795 (0%) 1/691 (0.1%) 0/689 (0%)
    Myopathy 0/783 (0%) 0/795 (0%) 0/691 (0%) 1/689 (0.1%)
    Osteonecrosis 0/783 (0%) 0/795 (0%) 1/691 (0.1%) 0/689 (0%)
    Spinal Column Stenosis 0/783 (0%) 0/795 (0%) 0/691 (0%) 1/689 (0.1%)
    Spondylitis 0/783 (0%) 0/795 (0%) 1/691 (0.1%) 0/689 (0%)
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Prostate Cancer 0/783 (0%) 0/795 (0%) 2/691 (0.3%) 2/689 (0.3%)
    Adenocarcinoma 0/783 (0%) 0/795 (0%) 0/691 (0%) 1/689 (0.1%)
    Bladder Neoplasm 0/783 (0%) 0/795 (0%) 1/691 (0.1%) 0/689 (0%)
    Breast Cancer 0/783 (0%) 0/795 (0%) 1/691 (0.1%) 0/689 (0%)
    Colon Adenoma 0/783 (0%) 0/795 (0%) 0/691 (0%) 1/689 (0.1%)
    Extranodal Marginal Zone B-Cell Lymphoma (Malt Type) 0/783 (0%) 0/795 (0%) 1/691 (0.1%) 0/689 (0%)
    Eyelid Tumour 0/783 (0%) 0/795 (0%) 1/691 (0.1%) 0/689 (0%)
    Gallbladder Cancer 0/783 (0%) 0/795 (0%) 1/691 (0.1%) 0/689 (0%)
    Lung Adenocarcinoma 0/783 (0%) 0/795 (0%) 1/691 (0.1%) 0/689 (0%)
    Lung Cancer Metastatic 0/783 (0%) 0/795 (0%) 1/691 (0.1%) 0/689 (0%)
    Neoplasm 0/783 (0%) 0/795 (0%) 1/691 (0.1%) 0/689 (0%)
    Neoplasm Prostate 1/783 (0.1%) 0/795 (0%) 0/691 (0%) 0/689 (0%)
    Throat Cancer 0/783 (0%) 0/795 (0%) 1/691 (0.1%) 0/689 (0%)
    Uterine Leiomyoma 0/783 (0%) 0/795 (0%) 1/691 (0.1%) 1/689 (0.1%)
    Nervous system disorders
    Syncope 0/783 (0%) 0/795 (0%) 3/691 (0.4%) 6/689 (0.9%)
    Presyncope 0/783 (0%) 0/795 (0%) 0/691 (0%) 3/689 (0.4%)
    Carotid Artery Stenosis 0/783 (0%) 0/795 (0%) 2/691 (0.3%) 0/689 (0%)
    Cerebrovascular Accident 0/783 (0%) 0/795 (0%) 2/691 (0.3%) 2/689 (0.3%)
    Dizziness 1/783 (0.1%) 0/795 (0%) 1/691 (0.1%) 2/689 (0.3%)
    Ischaemic Stroke 0/783 (0%) 0/795 (0%) 2/691 (0.3%) 0/689 (0%)
    Transient Ischaemic Attack 0/783 (0%) 1/795 (0.1%) 2/691 (0.3%) 1/689 (0.1%)
    Cerebral Haemorrhage 0/783 (0%) 0/795 (0%) 0/691 (0%) 1/689 (0.1%)
    Complicated Migraine 0/783 (0%) 0/795 (0%) 0/691 (0%) 1/689 (0.1%)
    Convulsion 0/783 (0%) 0/795 (0%) 1/691 (0.1%) 0/689 (0%)
    Grand Mal Convulsion 0/783 (0%) 0/795 (0%) 1/691 (0.1%) 0/689 (0%)
    Haemorrhage Intracranial 0/783 (0%) 0/795 (0%) 0/691 (0%) 1/689 (0.1%)
    Haemorrhagic Stroke 0/783 (0%) 0/795 (0%) 1/691 (0.1%) 0/689 (0%)
    Intracranial Hypotension 0/783 (0%) 0/795 (0%) 0/691 (0%) 1/689 (0.1%)
    Neuropathy Peripheral 0/783 (0%) 0/795 (0%) 1/691 (0.1%) 0/689 (0%)
    Radiculopathy 0/783 (0%) 0/795 (0%) 1/691 (0.1%) 0/689 (0%)
    Tremor 0/783 (0%) 0/795 (0%) 1/691 (0.1%) 0/689 (0%)
    Psychiatric disorders
    Depression 0/783 (0%) 0/795 (0%) 3/691 (0.4%) 0/689 (0%)
    Anxiety 0/783 (0%) 0/795 (0%) 1/691 (0.1%) 0/689 (0%)
    Confusional State 0/783 (0%) 0/795 (0%) 0/691 (0%) 1/689 (0.1%)
    Dependence 0/783 (0%) 0/795 (0%) 0/691 (0%) 1/689 (0.1%)
    Panic Attack 0/783 (0%) 0/795 (0%) 1/691 (0.1%) 0/689 (0%)
    Suicidal Ideation 0/783 (0%) 0/795 (0%) 1/691 (0.1%) 0/689 (0%)
    Renal and urinary disorders
    Nephrolithiasis 0/783 (0%) 0/795 (0%) 3/691 (0.4%) 0/689 (0%)
    Haematuria 0/783 (0%) 0/795 (0%) 2/691 (0.3%) 2/689 (0.3%)
    Bladder Neck Obstruction 1/783 (0.1%) 0/795 (0%) 0/691 (0%) 0/689 (0%)
    Calculus Bladder 0/783 (0%) 0/795 (0%) 1/691 (0.1%) 0/689 (0%)
    Renal Failure Acute 0/783 (0%) 0/795 (0%) 1/691 (0.1%) 0/689 (0%)
    Ureteric Stenosis 0/783 (0%) 0/795 (0%) 1/691 (0.1%) 0/689 (0%)
    Urinary Retention 0/783 (0%) 0/795 (0%) 1/691 (0.1%) 0/689 (0%)
    Reproductive system and breast disorders
    Benign Prostatic Hyperplasia 0/783 (0%) 0/795 (0%) 0/691 (0%) 1/689 (0.1%)
    Cystocele 0/783 (0%) 0/795 (0%) 0/691 (0%) 1/689 (0.1%)
    Gynaecomastia 0/783 (0%) 0/795 (0%) 1/691 (0.1%) 0/689 (0%)
    Vaginal Haemorrhage 1/783 (0.1%) 0/795 (0%) 0/691 (0%) 1/689 (0.1%)
    Respiratory, thoracic and mediastinal disorders
    Chronic Obstructive Pulmonary Disease 0/783 (0%) 0/795 (0%) 3/691 (0.4%) 2/689 (0.3%)
    Dyspnoea 0/783 (0%) 0/795 (0%) 3/691 (0.4%) 3/689 (0.4%)
    Pulmonary Embolism 0/783 (0%) 0/795 (0%) 1/691 (0.1%) 2/689 (0.3%)
    Acute Respiratory Failure 0/783 (0%) 0/795 (0%) 1/691 (0.1%) 0/689 (0%)
    Asthma 0/783 (0%) 0/795 (0%) 0/691 (0%) 1/689 (0.1%)
    Epistaxis 0/783 (0%) 1/795 (0.1%) 0/691 (0%) 0/689 (0%)
    Haemoptysis 0/783 (0%) 0/795 (0%) 1/691 (0.1%) 0/689 (0%)
    Haemothorax 0/783 (0%) 0/795 (0%) 1/691 (0.1%) 0/689 (0%)
    Hypoxia 0/783 (0%) 0/795 (0%) 1/691 (0.1%) 0/689 (0%)
    Nasal Obstruction 0/783 (0%) 0/795 (0%) 0/691 (0%) 1/689 (0.1%)
    Nasal Polyps 0/783 (0%) 0/795 (0%) 0/691 (0%) 1/689 (0.1%)
    Pneumonia Aspiration 0/783 (0%) 0/795 (0%) 1/691 (0.1%) 0/689 (0%)
    Pulmonary Mass 0/783 (0%) 0/795 (0%) 0/691 (0%) 1/689 (0.1%)
    Pulmonary Oedema 1/783 (0.1%) 0/795 (0%) 0/691 (0%) 0/689 (0%)
    Respiratory Failure 0/783 (0%) 0/795 (0%) 0/691 (0%) 1/689 (0.1%)
    Sleep Apnoea Syndrome 0/783 (0%) 1/795 (0.1%) 0/691 (0%) 1/689 (0.1%)
    Skin and subcutaneous tissue disorders
    Skin Ulcer 0/783 (0%) 0/795 (0%) 0/691 (0%) 1/689 (0.1%)
    Surgical and medical procedures
    Coronary Arterial Stent Insertion 0/783 (0%) 0/795 (0%) 1/691 (0.1%) 0/689 (0%)
    Vascular disorders
    Intermittent Claudication 0/783 (0%) 0/795 (0%) 2/691 (0.3%) 1/689 (0.1%)
    Subclavian Artery Stenosis 0/783 (0%) 0/795 (0%) 2/691 (0.3%) 0/689 (0%)
    Aortic Stenosis 0/783 (0%) 0/795 (0%) 1/691 (0.1%) 0/689 (0%)
    Arterial Occlusive Disease 0/783 (0%) 0/795 (0%) 0/691 (0%) 1/689 (0.1%)
    Arterial Stenosis 0/783 (0%) 0/795 (0%) 0/691 (0%) 1/689 (0.1%)
    Arteriosclerosis 0/783 (0%) 0/795 (0%) 1/691 (0.1%) 0/689 (0%)
    Deep Vein Thrombosis 0/783 (0%) 1/795 (0.1%) 1/691 (0.1%) 0/689 (0%)
    Femoral Arterial Stenosis 0/783 (0%) 0/795 (0%) 0/691 (0%) 1/689 (0.1%)
    Haematoma 0/783 (0%) 0/795 (0%) 1/691 (0.1%) 0/689 (0%)
    Hypertension 1/783 (0.1%) 0/795 (0%) 1/691 (0.1%) 1/689 (0.1%)
    Iliac Artery Stenosis 1/783 (0.1%) 0/795 (0%) 0/691 (0%) 0/689 (0%)
    Peripheral Ischaemia 0/783 (0%) 0/795 (0%) 0/691 (0%) 1/689 (0.1%)
    Thrombophlebitis Superficial 0/783 (0%) 0/795 (0%) 0/691 (0%) 1/689 (0.1%)
    Other (Not Including Serious) Adverse Events
    Rosuvastatin 20 mg Atorvastatin 40 mg Rosuvastatin 40 mg Atorvastatin 80 mg
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 0/783 (0%) 0/795 (0%) 210/691 (30.4%) 213/689 (30.9%)
    Cardiac disorders
    ANGINA PECTORIS 0/783 (0%) 0/795 (0%) 61/691 (8.8%) 65/689 (9.4%)
    General disorders
    FATIGUE 0/783 (0%) 0/795 (0%) 32/691 (4.6%) 39/689 (5.7%)
    Musculoskeletal and connective tissue disorders
    MYALGIA 0/783 (0%) 0/795 (0%) 99/691 (14.3%) 91/689 (13.2%)
    ARTHRALGIA 0/783 (0%) 0/795 (0%) 50/691 (7.2%) 43/689 (6.2%)
    Vascular disorders
    HYPERTENSION 0/783 (0%) 0/795 (0%) 36/691 (5.2%) 40/689 (5.8%)

    Limitations/Caveats

    [Not Specified]

    More Information

    Certain Agreements

    Principal Investigators are NOT employed by the organization sponsoring the study.

    The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.

    Results Point of Contact

    Name/Title Gerard Lynch
    Organization AstraZeneca
    Phone
    Email aztrial_results_posting@astrazeneca.com
    Responsible Party:
    AstraZeneca
    ClinicalTrials.gov Identifier:
    NCT00620542
    Other Study ID Numbers:
    • D356IC00001
    • 2007-004000-13
    First Posted:
    Feb 21, 2008
    Last Update Posted:
    Jul 16, 2012
    Last Verified:
    Jul 1, 2012