A Study of Evacetrapib (LY2484595) in Participants With High Cholesterol
- Conditions
- Hyperlipidemia
- Interventions
- Registration Number
- NCT02227784
- Lead Sponsor
- Eli Lilly and Company
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 366
- Must be treated with atorvastatin 40 mg/day for at least 30 days prior to screening
- Have an LDL-C >70 mg/deciliter(dL) or non-HDL-C >100 mg/dL
- Have screening triglycerides ≤400 mg/dL (≤4.5 millimoles/Liter)
- Individuals with ASCVD and/or individuals with type 1 or type 2 diabetes
- Have a hemoglobin A1c (HbA1c) >9.5%
- New York Heart Association (NYHA) class III or IV congestive heart failure
- History of either a transient ischemic stroke or ischemic stroke <30 days
- History of acute coronary syndrome (ACS) <30 days
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Atorvastatin + Evacetrapib Evacetrapib Atorvastatin 40 milligrams (mg) orally once daily for 28 days during lead in period. Atorvastatin 40 mg plus evacetrapib 130 mg with placebo for blinding orally once daily for 90 days. Open label extension (atorvastatin 40 mg plus evacetrapib 130 mg) is available for compliant participants. Atorvastatin + Evacetrapib Placebo Atorvastatin 40 milligrams (mg) orally once daily for 28 days during lead in period. Atorvastatin 40 mg plus evacetrapib 130 mg with placebo for blinding orally once daily for 90 days. Open label extension (atorvastatin 40 mg plus evacetrapib 130 mg) is available for compliant participants. Atorvastatin 80 mg Atorvastatin Atorvastatin 40 mg orally once daily for 28 days during lead in period. Atorvastatin 80 mg orally with placebo for blinding once daily for 90 days. Open label extension (atorvastatin 40 mg plus evacetrapib 130 mg) is available for compliant participants. Atorvastatin 80 mg Placebo Atorvastatin 40 mg orally once daily for 28 days during lead in period. Atorvastatin 80 mg orally with placebo for blinding once daily for 90 days. Open label extension (atorvastatin 40 mg plus evacetrapib 130 mg) is available for compliant participants. Atorvastatin + Ezetimibe Atorvastatin Atorvastatin 40 mg orally once daily for 28 days during lead in period. Atorvastatin 40 mg plus ezetimibe 10 mg with placebo for blinding orally once daily for 90 days. Open label extension (atorvastatin 40 mg plus evacetrapib 130 mg) is available for compliant participants. Atorvastatin + Ezetimibe Placebo Atorvastatin 40 mg orally once daily for 28 days during lead in period. Atorvastatin 40 mg plus ezetimibe 10 mg with placebo for blinding orally once daily for 90 days. Open label extension (atorvastatin 40 mg plus evacetrapib 130 mg) is available for compliant participants. Atorvastatin 40 mg Placebo Atorvastatin 40 mg orally once daily for 28 days during lead in period. Atorvastatin 40 mg with placebo for blinding orally once daily for 90 days. Open label extension (atorvastatin 40 mg plus evacetrapib 130 mg) is available for compliant participants. Atorvastatin + Evacetrapib Atorvastatin Atorvastatin 40 milligrams (mg) orally once daily for 28 days during lead in period. Atorvastatin 40 mg plus evacetrapib 130 mg with placebo for blinding orally once daily for 90 days. Open label extension (atorvastatin 40 mg plus evacetrapib 130 mg) is available for compliant participants. Atorvastatin + Ezetimibe Ezetimibe Atorvastatin 40 mg orally once daily for 28 days during lead in period. Atorvastatin 40 mg plus ezetimibe 10 mg with placebo for blinding orally once daily for 90 days. Open label extension (atorvastatin 40 mg plus evacetrapib 130 mg) is available for compliant participants. Atorvastatin 40 mg Atorvastatin Atorvastatin 40 mg orally once daily for 28 days during lead in period. Atorvastatin 40 mg with placebo for blinding orally once daily for 90 days. Open label extension (atorvastatin 40 mg plus evacetrapib 130 mg) is available for compliant participants.
- Primary Outcome Measures
Name Time Method Percent Change From Baseline to 3 Months in Low-Density Lipoprotein Cholesterol (LDL-C) Baseline, 3 Months 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.
- Secondary Outcome Measures
Name Time Method Percent Change From Baseline to 3 Months in High-Density Lipoprotein Cholesterol (HDL-C) Baseline, 3 Months 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.
Percent Change From Baseline to 3 Months in Apolipoprotein AI (apoAI) Baseline, 3 Months 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.
Percent Change From Baseline to 3 Months in Non-HDL-C Baseline, 3 Months 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.
Percent Change From Baseline to 3 Months in Apolipoprotein B (apoB) Baseline, 3 Months 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.
Percent Change From Baseline to 3 Months in Cholesterol Efflux Capacity Baseline, 3 Months 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.
Percent Change From Baseline to 3 Months in Lipoprotein(a) (Lp[a]) Baseline, 3 Months 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.
Trial Locations
- Locations (63)
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
Scroll for more (53 remaining)Heart Center Research, LLC🇺🇸Huntsville, Alabama, United States