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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
2,333
capsule, oral, once daily
capsule, oral, one daily
Change From Baseline to End of Study (Week 104) in Percent Atheroma Volume (PAV)
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)
Numbers of Patients Showing Regression in PAV
Regression defined as a change from baseline in PAV \< 0
Time frame: End of study (Week 104)
Change From Baseline to End of Study (Week 104) in Total Atheroma Volume (TAV)
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)
Numbers of Patients Showing Regression in TAV
Regression defined as a change from baseline in TAV \< 0
Time frame: End of study (Week 104)
Total Cholesterol Blood Level
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
LDL-C Blood Level
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.
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Research Site
Huntsville, Alabama, United States
Research Site
Los Angeles, California, United States
Research Site
Mountain View, California, United States
Research Site
Sacramento, California, United States
Research Site
San Diego, California, United States
Research Site
Santa Rosa, California, United States
Research Site
Torrance, California, United States
Research Site
Boulder, Colorado, United States
Research Site
Greeley, Colorado, United States
Research Site
Loveland, Colorado, United States
...and 185 more locations
Time frame: 104 weeks
HDL-C Blood Level
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
Triglycerides Blood Level
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
Non-HDL-C Blood Level
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
LDL-C/HDL-C Blood Level
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
Total Cholesterol/HDL-C Blood Level
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
Non-HDL-C/HDL-C Blood Level
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
Apolipoprotein B Blood Level
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
Apolipoprotein A-1 Blood Level
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
Apoliprotein B/Apolipoprotein A-1 Blood Level
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
VLDL-C During the 104 Week Treatment Period
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