The purpose of the ACCENTUATE study is to evaluate whether the study drug known as evacetrapib is effective in treating participants with high cholesterol and atherosclerotic cardiovascular disease (ASCVD) and/or diabetes.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
366
Administered orally
Administered orally
Administered orally
Percent Change From Baseline to 3 Months in Low-Density Lipoprotein Cholesterol (LDL-C)
Change in LDL-C levels from baseline to the 3-month visit expressed as a percentage of the baseline levels. LDL-C was measured by beta quantification. Statistics are from analysis of covariance with log baseline measurement and treatment is included in the model. Least Square Means (LS means) and median differences were analyzed in log units and converted to standard units. Log Percent change from baseline response is the dependent variable.
Time frame: Baseline, 3 Months
Percent Change From Baseline to 3 Months in High-Density Lipoprotein Cholesterol (HDL-C)
Change in HDL-C levels from baseline to the 3-month visit expressed as a percentage of the baseline levels. LS medians and median differences were analyzed in log units and converted to standard units. Statistics are from mixed model repeated measures analysis with log baseline measurement, treatment, visit, and treatment by visit interaction included in the model. Log percent change from baseline response is the dependent variable. Within-participant repeated measures at multiple visits are modeled by a compound symmetry covariance structure.
Time frame: Baseline, 3 Months
Percent Change From Baseline to 3 Months in Apolipoprotein AI (apoAI)
Change in apoAI levels from baseline to the 3-month visit expressed as a percentage of the baseline levels. Statistics are from analysis of covariance with log baseline measurement and treatment is included in the model. LS means and median differences were analyzed in log units and converted to standard units. Log Percent change from baseline response is the dependent variable.
Time frame: Baseline, 3 Months
Percent Change From Baseline to 3 Months in Non-HDL-C
Change in Non-HDL-C levels from baseline to the 3-month visit expressed as a percentage of the baseline levels. LS medians and median differences were analyzed in log units and converted to standard units. Statistics are from mixed model repeated measures analysis with log baseline measurement, treatment, visit, and treatment by visit interaction included in the model. Log percent change from baseline response is the dependent variable. Within-participant repeated measures at multiple visits are modeled by a compound symmetry covariance structure.
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Administered orally
Heart Center Research, LLC
Huntsville, Alabama, United States
Desert Clinical Research
Mesa, Arizona, United States
Central Phoenix Med Clinic LLC
Phoenix, Arizona, United States
Advanced Clinical Research
Carmichael, California, United States
Tooraj Joseph Raoof M.D., Inc.
Encino, California, United States
Irvine Clinical Research Center
Irvine, California, United States
VA Long Beach Healthcare System
Long Beach, California, United States
Rancho Cucamonga Clinical
Rancho Cucamonga, California, United States
Encompass Clinical Research
Spring Valley, California, United States
University Clinical Investigators, Inc.
Tustin, California, United States
...and 54 more locations
Time frame: Baseline, 3 Months
Percent Change From Baseline to 3 Months in Apolipoprotein B (apoB)
Change in apoB levels from baseline to the 3-month visit expressed as a percentage of the baseline levels. Statistics are from analysis of covariance with log baseline measurement and treatment is included in the model. LS means and median differences were analyzed in log units and converted to standard units. Log Percent change from baseline response is the dependent variable.
Time frame: Baseline, 3 Months
Percent Change From Baseline to 3 Months in Cholesterol Efflux Capacity
Change in cholesterol efflux capacity from baseline to the 3-month visit expressed as a percentage of the baseline levels. Statistics are from analysis of covariance with log baseline measurement and treatment is included in the model. LS means and median differences were analyzed in log units and converted to standard units. Log Percent change from baseline response is the dependent variable.
Time frame: Baseline, 3 Months
Percent Change From Baseline to 3 Months in Lipoprotein(a) (Lp[a])
Change in Lp(a) levels from baseline to the 3-month visit expressed as a percentage of the baseline levels. Statistics are from analysis of covariance with log baseline measurement and treatment is included in the model. LS means and median differences were analyzed in log units and converted to standard units. Log Percent change from baseline response is the dependent variable.
Time frame: Baseline, 3 Months