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The purpose of this study is to determine if Bempedoic Acid (BA) + Ezetimibe (EZE) in a fixed-dose combination (FDC) is effective and safe versus its individual components and placebo in patients with elevated LDL cholesterol treated with maximally tolerated statin therapy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BA 180 mg + EZE 10 mg FDC | Experimental | Bempedoic acid (BA) + ezetimibe (EZE) fixed-dose combination (FDC) 180 mg/10 mg tablets taken orally once daily for 12 weeks |
|
| BA 180 mg | Experimental | Bempedoic acid (BA) 180 mg tablets taken orally once daily for 12 weeks |
|
| EZE 10 mg | Active Comparator | Ezetimibe (EZE) 10 mg overencapsulated tablets taken orally once daily for 12 weeks |
|
| Placebos | Placebo Comparator | Placebos to match identical bempedoic acid + ezetimibe fixed-dose combination (FDC) 180 mg/10 mg tablet, or identical bempedoic acid 180 mg tablet, or identical ezetimibe 10 mg capsule, taken orally, once daily for 12 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bempedoic Acid + Ezetimibe Fixed-Dose Combination | Combination Product | bempedoic acid + ezetimibe FDC 180 mg/10 mg tablet |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percent Change From Baseline to Week 12 in Low-density Lipoprotein Cholesterol (LDL-C) | Blood samples were drawn after a minimum 10-hour fast (water was allowed) at pre-specified intervals. Samples were collected and analyzed for LDL-C. Baseline was defined as the mean of the LDL-C values from Week -2 and predose Day 1/Week 0. Percent change from baseline in LDL-C was analyzed using analysis of covariance (ANCOVA) with treatment group and randomization stratification as a factors and baseline LDL-C as a covariate. Percent change from baseline was calculated as: ([LDL-C value at Week 12 minus Baseline value] divided by [Baseline Value]) multiplied by 100. For LDL-C, if measured LDL-C value was available, measured LDL-C was used. | Baseline; Week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Percent Change From Baseline to Week 12 in High-sensitivity C-reactive Protein (hsCRP) | Blood samples were drawn after a minimum 10-hour fast (water was allowed) at pre-specified intervals. Samples were collected and analyzed for hsCRP. Baseline was defined as the predose Day 1/Week 0 value. Percent change from baseline in hsCRP was analyzed using a non-parametric analysis. Percent change from baseline was calculated as: ([hsCRP value at Week 12 minus Baseline value] divided by [Baseline Value]) multiplied by 100. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ron Haberman, MD | Esperion Therapeutics, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| PMG Research of McFarland | Ames | Iowa | 50010 | United States | ||
| Foundation Cardiology |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27892461 | Background | Pinkosky SL, Newton RS, Day EA, Ford RJ, Lhotak S, Austin RC, Birch CM, Smith BK, Filippov S, Groot PHE, Steinberg GR, Lalwani ND. Liver-specific ATP-citrate lyase inhibition by bempedoic acid decreases LDL-C and attenuates atherosclerosis. Nat Commun. 2016 Nov 28;7:13457. doi: 10.1038/ncomms13457. | |
| 21067804 | Background |
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Data are presented for the Full Analysis Set, comprised of all randomized participants. One participant was randomized but was not treated.
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Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Bempedoic Acid 180 mg + Ezetimibe 10 mg FDC | Participants received bempedoic acid + ezetimibe fixed-dose combination (FDC) 180 milligrams (mg)/10 mg tablets orally once daily for 12 weeks. |
| FG001 | Bempedoic Acid 180 mg |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Oct 18, 2017 | Mar 17, 2020 |
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| Bempedoic Acid | Drug | bempedoic acid 180 mg tablet |
|
|
| Ezetimibe | Drug | ezetimibe 10 mg overencapsulated tablet |
|
|
| Placebos | Drug | placebo tablet or capsule to match bempedoic acid + ezetimibe fixed-dose combination (FDC) 180 mg/10 mg tablet, or bempedoic acid 180 mg tablet, or ezetimibe 10 mg capsule |
|
|
| Baseline; Week 12 |
| Percent Change From Baseline to Week 12 in Non-high-density Lipoprotein Cholesterol (Non-HDL-C) | Blood samples were drawn after a minimum 10-hour fast (water was allowed) at pre-specified intervals. Samples were collected and analyzed for non-HDL-C. Baseline was defined as the mean of the non-HDL-C values from Week -2 and predose Day 1/Week 0. Percent change from baseline in non-HDL-C was analyzed using ANCOVA with treatment group and randomization stratification as a factors and baseline non-HDL-C as a covariate. Percent change from baseline was calculated as: ([non-HDL-C value at Week 12 minus Baseline value] divided by [Baseline Value]) multiplied by 100. | Baseline; Week 12 |
| Percent Change From Baseline to Week 12 in Total Cholesterol (TC) | Blood samples were drawn after a minimum 10-hour fast (water was allowed) at pre-specified intervals. Samples were collected and analyzed for TC. Baseline was defined as the mean of the TC values from Week -2 and predose Day 1/Week 0. Percent change from baseline in TC was analyzed using ANCOVA with treatment group and randomization stratification as a factors and baseline TC as a covariate. Percent change from baseline was calculated as: ([TC value at Week 12 minus Baseline value] divided by [Baseline Value]) multiplied by 100. | Baseline; Week 12 |
| Percent Change From Baseline to Week 12 in Apolipoprotein B (Apo B) | Blood samples were drawn after a minimum 10-hour fast (water was allowed) at pre-specified intervals. Samples were collected and analyzed for apo B. Baseline was defined as the predose Day 1/Week 0 value. Percent change from baseline in apo B was analyzed using ANCOVA with treatment group and randomization stratification as a factors and baseline apo B as a covariate. Percent change from baseline was calculated as: ([apo B value at Week 12 minus Baseline value] divided by [Baseline Value]) multiplied by 100. | Baseline; Week 12 |
| Percent Change From Baseline to Week 12 in High-density Lipoprotein Cholesterol (HDL-C) | Blood samples were drawn after a minimum 10-hour fast (water was allowed) at pre-specified intervals. Samples were collected and analyzed for HDL-C. Baseline was defined as the mean of the HDL-C values from Week -2 and predose Day 1/Week 0. Percent change from baseline was calculated as: ([HDL-C value at Week 12 minus Baseline value] divided by [Baseline Value]) multiplied by 100. | Baseline; Week 12 |
| Percent Change From Baseline to Week 12 in Triglycerides (TGs) | Blood samples were drawn after a minimum 10-hour fast (water was allowed) at pre-specified intervals. Samples were collected and analyzed for TGs. Baseline was defined as the mean of the TGs values from Week -2 and predose Day 1/Week 0. Percent change from baseline was calculated as: ([TGs value at Week 12 minus Baseline value] divided by [Baseline Value]) multiplied by 100. | Baseline; Week 12 |
| Nashua |
| New Hampshire |
| 03060 |
| United States |
| PMG Research of Piedmont Healthcare | Statesville | North Carolina | 28625 | United States |
| PMG Research of Wilmington | Wilmington | North Carolina | 28401 | United States |
| PMG Research of Knoxville | Knoxville | Tennessee | 37912 | United States |
| Cholesterol Treatment Trialists' (CTT) Collaboration; Baigent C, Blackwell L, Emberson J, Holland LE, Reith C, Bhala N, Peto R, Barnes EH, Keech A, Simes J, Collins R. Efficacy and safety of more intensive lowering of LDL cholesterol: a meta-analysis of data from 170,000 participants in 26 randomised trials. Lancet. 2010 Nov 13;376(9753):1670-81. doi: 10.1016/S0140-6736(10)61350-5. Epub 2010 Nov 8. |
| 27594540 | Background | Authors/Task Force Members:; Catapano AL, Graham I, De Backer G, Wiklund O, Chapman MJ, Drexel H, Hoes AW, Jennings CS, Landmesser U, Pedersen TR, Reiner Z, Riccardi G, Taskinen MR, Tokgozoglu L, Verschuren WM, Vlachopoulos C, Wood DA, Zamorano JL. 2016 ESC/EAS Guidelines for the Management of Dyslipidaemias: The Task Force for the Management of Dyslipidaemias of the European Society of Cardiology (ESC) and European Atherosclerosis Society (EAS) Developed with the special contribution of the European Assocciation for Cardiovascular Prevention & Rehabilitation (EACPR). Atherosclerosis. 2016 Oct;253:281-344. doi: 10.1016/j.atherosclerosis.2016.08.018. Epub 2016 Sep 1. No abstract available. |
| 27673306 | Background | Silverman MG, Ference BA, Im K, Wiviott SD, Giugliano RP, Grundy SM, Braunwald E, Sabatine MS. Association Between Lowering LDL-C and Cardiovascular Risk Reduction Among Different Therapeutic Interventions: A Systematic Review and Meta-analysis. JAMA. 2016 Sep 27;316(12):1289-97. doi: 10.1001/jama.2016.13985. |
| 24222016 | Background | Stone NJ, Robinson JG, Lichtenstein AH, Bairey Merz CN, Blum CB, Eckel RH, Goldberg AC, Gordon D, Levy D, Lloyd-Jones DM, McBride P, Schwartz JS, Shero ST, Smith SC Jr, Watson K, Wilson PW, Eddleman KM, Jarrett NM, LaBresh K, Nevo L, Wnek J, Anderson JL, Halperin JL, Albert NM, Bozkurt B, Brindis RG, Curtis LH, DeMets D, Hochman JS, Kovacs RJ, Ohman EM, Pressler SJ, Sellke FW, Shen WK, Smith SC Jr, Tomaselli GF; American College of Cardiology/American Heart Association Task Force on Practice Guidelines. 2013 ACC/AHA guideline on the treatment of blood cholesterol to reduce atherosclerotic cardiovascular risk in adults: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines. Circulation. 2014 Jun 24;129(25 Suppl 2):S1-45. doi: 10.1161/01.cir.0000437738.63853.7a. Epub 2013 Nov 12. No abstract available. |
| 31357887 | Derived | Ballantyne CM, Laufs U, Ray KK, Leiter LA, Bays HE, Goldberg AC, Stroes ES, MacDougall D, Zhao X, Catapano AL. Bempedoic acid plus ezetimibe fixed-dose combination in patients with hypercholesterolemia and high CVD risk treated with maximally tolerated statin therapy. Eur J Prev Cardiol. 2020 Apr;27(6):593-603. doi: 10.1177/2047487319864671. Epub 2019 Jul 29. |
Participants received bempedoic acid 180 mg tablets taken orally once daily for 12 weeks.
| FG002 | Ezetimibe 10 mg | Participants received ezetimibe 10 mg overencapsulated tablets orally once daily for 12 weeks. |
| FG003 | Placebo | Participants received placebo to match the bempedoic acid + ezetimibe fixed-dose combination (FDC) 180 mg/10 mg tablet, the bempedoic acid 180 mg tablet, or the ezetimibe 10 mg capsule, taken orally, once daily for 12 weeks. |
| COMPLETED |
|
| NOT COMPLETED |
|
|
Data are presented for the Full Analysis Set, comprised of all randomized participants. One participant was randomized but was not treated.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Bempedoic Acid 180 mg + Ezetimibe 10 mg FDC | Participants received bempedoic acid + ezetimibe fixed-dose combination (FDC) 180 milligrams (mg)/10 mg tablets orally once daily for 12 weeks. |
| BG001 | Bempedoic Acid 180 mg | Participants received bempedoic acid 180 mg tablets taken orally once daily for 12 weeks. |
| BG002 | Ezetimibe 10 mg | Participants received ezetimibe 10 mg overencapsulated tablets orally once daily for 12 weeks. |
| BG003 | Placebo | Participants received placebo to match the bempedoic acid + ezetimibe FDC 180 mg/10 mg tablet, the bempedoic acid 180 mg tablet, or the ezetimibe 10 mg capsule, taken orally, once daily for 12 weeks. |
| BG004 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | Years |
| ||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| |||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| |||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| |||||||||||
| Low-density lipoprotein cholesterol (LDL-C) | Baseline was defined as the mean of the last 2 non-missing values from Week -2 (Screening Visit [Visit S1]) and predose Day 1/Week 0 (Treatment Visit 1 [Visit T1]). | After a Root Cause Analysis, three sites were found not to have followed Good Clinical Practice; therefore, analysis was completed with all data from these sites removed. | Mean | Standard Deviation | milligrams per deciliter (mg/dL) |
| ||||||||
| Non-high-density lipoprotein cholesterol (non-HDL-C) | Baseline was defined as the mean of the last 2 non-missing values from Week -2 (Screening Visit [Visit S1]) and predose Day 1/Week 0 (Treatment Visit 1 [Visit T1]). | After a Root Cause Analysis, three sites were found not to have followed Good Clinical Practice; therefore, analysis was completed with all data from these sites removed. | Mean | Standard Deviation | mg/dL |
| ||||||||
| Total cholesterol (TC) | Baseline was defined as the mean of the last 2 non-missing values from Week -2 (Screening Visit [Visit S1]) and predose Day 1/Week 0 (Treatment Visit 1 [Visit T1]). | After a Root Cause Analysis, three sites were found not to have followed Good Clinical Practice; therefore, analysis was completed with all data from these sites removed. | Mean | Standard Deviation | mg/dL |
| ||||||||
| Apolipoprotein B (apo B) | Baseline was defined as the predose Day 1/Week 0 (Visit T1) value. | After a Root Cause Analysis, three sites were found not to have followed Good Clinical Practice; therefore, analysis was completed with all data from these sites removed. Only participants with available data were analyzed. | Mean | Standard Deviation | mg/dL |
| ||||||||
| High-sensitivity C-reactive protein (hsCRP) | Baseline was defined as the predose Day 1/Week 0 (Visit T1) value. | After a Root Cause Analysis, three sites were found not to have followed Good Clinical Practice; therefore, analysis was completed with all data from these sites removed. Only participants with available data were analyzed. | Median | Inter-Quartile Range | milligrams per liter (mg/L) |
| ||||||||
| Triglycerides (TGs) | Baseline was defined as the mean of the last 2 non-missing values from Week -2 (Screening Visit [Visit S1]) and predose Day 1/Week 0 (Treatment Visit 1 [Visit T1]). | After a Root Cause Analysis, three sites were found not to have followed Good Clinical Practice; therefore, analysis was completed with all data from these sites removed. | Mean | Standard Deviation | mg/dL |
| ||||||||
| High-density lipoprotein cholesterol (HDL-C) | Baseline was defined as the mean of the last 2 non-missing values from Week -2 (Screening Visit [Visit S1]) and predose Day 1/Week 0 (Treatment Visit 1 [Visit T1]). | After a Root Cause Analysis, three sites were found not to have followed Good Clinical Practice; therefore, analysis was completed with all data from these sites removed. | Mean | Standard Deviation | mg/dL |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Percent Change From Baseline to Week 12 in Low-density Lipoprotein Cholesterol (LDL-C) | Blood samples were drawn after a minimum 10-hour fast (water was allowed) at pre-specified intervals. Samples were collected and analyzed for LDL-C. Baseline was defined as the mean of the LDL-C values from Week -2 and predose Day 1/Week 0. Percent change from baseline in LDL-C was analyzed using analysis of covariance (ANCOVA) with treatment group and randomization stratification as a factors and baseline LDL-C as a covariate. Percent change from baseline was calculated as: ([LDL-C value at Week 12 minus Baseline value] divided by [Baseline Value]) multiplied by 100. For LDL-C, if measured LDL-C value was available, measured LDL-C was used. | Full Analysis Set (FAS), also known as the intention-to-treat set, was defined as all randomized participants. After a Root Cause Analysis, three sites were found not to have followed Good Clinical Practice; therefore, analysis was completed with all efficacy data from these sites removed. | Posted | Least Squares Mean | Standard Error | Percent Change | Baseline; Week 12 |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percent Change From Baseline to Week 12 in High-sensitivity C-reactive Protein (hsCRP) | Blood samples were drawn after a minimum 10-hour fast (water was allowed) at pre-specified intervals. Samples were collected and analyzed for hsCRP. Baseline was defined as the predose Day 1/Week 0 value. Percent change from baseline in hsCRP was analyzed using a non-parametric analysis. Percent change from baseline was calculated as: ([hsCRP value at Week 12 minus Baseline value] divided by [Baseline Value]) multiplied by 100. | FAS. Only participants with available data were analyzed. After a Root Cause Analysis, three sites were found not to have followed Good Clinical Practice;therefore, analysis was completed with all efficacy data from these sites removed. | Posted | Median | Inter-Quartile Range | Percent Change | Baseline; Week 12 |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percent Change From Baseline to Week 12 in Non-high-density Lipoprotein Cholesterol (Non-HDL-C) | Blood samples were drawn after a minimum 10-hour fast (water was allowed) at pre-specified intervals. Samples were collected and analyzed for non-HDL-C. Baseline was defined as the mean of the non-HDL-C values from Week -2 and predose Day 1/Week 0. Percent change from baseline in non-HDL-C was analyzed using ANCOVA with treatment group and randomization stratification as a factors and baseline non-HDL-C as a covariate. Percent change from baseline was calculated as: ([non-HDL-C value at Week 12 minus Baseline value] divided by [Baseline Value]) multiplied by 100. | FAS. After a Root Cause Analysis, three sites were found not to have followed Good Clinical Practice; therefore, analysis was completed with all efficacy data from these sites removed. | Posted | Least Squares Mean | Standard Error | Percent change | Baseline; Week 12 |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percent Change From Baseline to Week 12 in Total Cholesterol (TC) | Blood samples were drawn after a minimum 10-hour fast (water was allowed) at pre-specified intervals. Samples were collected and analyzed for TC. Baseline was defined as the mean of the TC values from Week -2 and predose Day 1/Week 0. Percent change from baseline in TC was analyzed using ANCOVA with treatment group and randomization stratification as a factors and baseline TC as a covariate. Percent change from baseline was calculated as: ([TC value at Week 12 minus Baseline value] divided by [Baseline Value]) multiplied by 100. | FAS. Only participants with available data were analyzed. After a Root Cause Analysis, three sites were found not to have followed Good Clinical Practice; therefore, analysis was completed with all efficacy data from these sites removed. | Posted | Least Squares Mean | Standard Error | Percent change | Baseline; Week 12 |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percent Change From Baseline to Week 12 in Apolipoprotein B (Apo B) | Blood samples were drawn after a minimum 10-hour fast (water was allowed) at pre-specified intervals. Samples were collected and analyzed for apo B. Baseline was defined as the predose Day 1/Week 0 value. Percent change from baseline in apo B was analyzed using ANCOVA with treatment group and randomization stratification as a factors and baseline apo B as a covariate. Percent change from baseline was calculated as: ([apo B value at Week 12 minus Baseline value] divided by [Baseline Value]) multiplied by 100. | FAS. After a Root Cause Analysis, three sites were found not to have followed Good Clinical Practice; therefore, analysis was completed with all efficacy data from these sites removed. Only participants with available data were analyzed. | Posted | Least Squares Mean | Standard Error | Percent change | Baseline; Week 12 |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percent Change From Baseline to Week 12 in High-density Lipoprotein Cholesterol (HDL-C) | Blood samples were drawn after a minimum 10-hour fast (water was allowed) at pre-specified intervals. Samples were collected and analyzed for HDL-C. Baseline was defined as the mean of the HDL-C values from Week -2 and predose Day 1/Week 0. Percent change from baseline was calculated as: ([HDL-C value at Week 12 minus Baseline value] divided by [Baseline Value]) multiplied by 100. | FAS. Only participants with available data were analyzed. After a Root Cause Analysis, three sites were found not to have followed Good Clinical Practice; therefore, analysis was completed with all efficacy data from these sites removed. | Posted | Mean | Standard Deviation | Percent change | Baseline; Week 12 |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percent Change From Baseline to Week 12 in Triglycerides (TGs) | Blood samples were drawn after a minimum 10-hour fast (water was allowed) at pre-specified intervals. Samples were collected and analyzed for TGs. Baseline was defined as the mean of the TGs values from Week -2 and predose Day 1/Week 0. Percent change from baseline was calculated as: ([TGs value at Week 12 minus Baseline value] divided by [Baseline Value]) multiplied by 100. | FAS. Only participants with available data were analyzed. After a Root Cause Analysis, three sites were found not to have followed Good Clinical Practice; therefore, analysis was completed with all efficacy data from these sites removed. | Posted | Mean | Standard Deviation | Percent change | Baseline; Week 12 |
|
Up to approximately 14 weeks
Treatment-emergent adverse events (TEAEs) are defined as adverse events (AEs) that began or worsened after the first dose of investigational medicinal product (IMP). The analysis was performed using the Safety Analysis Set which consists of all randomized participants who received at least 1 dose of blinded IMP.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Bempedoic Acid 180 mg + Ezetimibe 10 mg FDC | Participants received bempedoic acid + ezetimibe fixed-dose combination (FDC) 180 milligrams (mg)/10 mg tablets orally once daily for 12 weeks. | 0 | 107 | 8 | 107 | 26 | 107 |
| EG001 | Bempedoic Acid 180 mg | Participants received bempedoic acid 180 mg tablets taken orally once daily for 12 weeks. | 0 | 110 | 7 | 110 | 27 | 110 |
| EG002 | Ezetimibe 10 mg | Participants received ezetimibe 10 mg overencapsulated tablets orally once daily for 12 weeks. | 0 | 109 | 10 | 109 | 26 | 109 |
| EG003 | Placebo | Participants received placebo to match the bempedoic acid + ezetimibe fixed-dose combination (FDC) 180 mg/10 mg tablet, the bempedoic acid 180 mg tablet, or the ezetimibe 10 mg capsule, taken orally, once daily for 12 weeks. | 0 | 55 | 1 | 55 | 12 | 55 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Acute myocardial infarction | Cardiac disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Angina pectoris | Cardiac disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Cardiac failure congestive | Cardiac disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Coronary artery disease | Cardiac disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Myocardial infarction | Cardiac disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Myocardial ischaemia | Cardiac disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Supraventricular tachycardia | Cardiac disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Non-cardiac chest pain | General disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Diverticulitis | Infections and infestations | MedDRA 20.1 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 20.1 | Systematic Assessment |
| |
| Rhinovirus infection | Infections and infestations | MedDRA 20.1 | Systematic Assessment |
| |
| Coronary vascular graft stenosis | Injury, poisoning and procedural complications | MedDRA 20.1 | Systematic Assessment |
| |
| Limb injury | Injury, poisoning and procedural complications | MedDRA 20.1 | Systematic Assessment |
| |
| Ovarian cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 20.1 | Systematic Assessment |
| |
| Hemiparesis | Nervous system disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Confusional state | Psychiatric disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Deep vein thrombosis | Vascular disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Renal artery occlusion | Renal and urinary disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Chronic respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA 20.1 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA 20.1 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 20.1 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA 20.1 | Systematic Assessment |
|
After a Root Cause Analysis, three sites were found not to have followed Good Clinical Practice; therefore, analysis was completed with all data from these sites removed.
If the Principal Investigator plans to publish information from the study, a copy of the manuscript should be provided to the Sponsor for review before submission for publication or presentation. The Sponsor may request that that publication be withheld.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Medical Director | Esperion Therapeutics, Inc. | 1-833-377-7633 | medinfo@esperion.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jun 8, 2018 | Mar 17, 2020 | SAP_001.pdf |
| ID | Term |
|---|---|
| D006949 | Hyperlipidemias |
| D050197 | Atherosclerosis |
| D006937 | Hypercholesterolemia |
| ID | Term |
|---|---|
| D050171 | Dyslipidemias |
| D052439 | Lipid Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C581236 | 8-hydroxy-2,2,14,14-tetramethylpentadecanedioic acid |
| D000069438 | Ezetimibe |
| ID | Term |
|---|---|
| D001384 | Azetidines |
| D001385 | Azetines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
Not provided
Not provided
|
|
|
|
|
|
|
|
|
|
|
| <0.001 |
| Difference of LS means |
| -19.0 |
| Standard Error of the Mean |
| 3.60 |
| 2-Sided |
| 95 |
| -26.1 |
| -11.9 |
Standard Error of the Difference of LS Means |
| Superiority |
| ANCOVA | <0.001 | Difference of LS means | -13.1 | Standard Error of the Mean | 3.37 | 2-Sided | 95 | -19.7 | -6.5 | Standard Error of the Difference of LS Means | Superiority |
| OG003 | Placebo | Participants received placebo to match the bempedoic acid + ezetimibe fixed-dose combination (FDC) 180 mg/10 mg tablet, the bempedoic acid 180 mg tablet, or the ezetimibe 10 mg capsule, taken orally, once daily for 12 weeks. |
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Participants received ezetimibe 10 mg overencapsulated tablets orally once daily for 12 weeks. |
| OG003 | Placebo | Participants received placebo to match the bempedoic acid + ezetimibe fixed-dose combination (FDC) 180 mg/10 mg tablet, the bempedoic acid 180 mg tablet, or the ezetimibe 10 mg capsule, taken orally, once daily for 12 weeks. |
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Participants received ezetimibe 10 mg overencapsulated tablets orally once daily for 12 weeks. |
| OG003 | Placebo | Participants received placebo to match the bempedoic acid + ezetimibe fixed-dose combination (FDC) 180 mg/10 mg tablet, the bempedoic acid 180 mg tablet, or the ezetimibe 10 mg capsule, taken orally, once daily for 12 weeks. |
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Participants received ezetimibe 10 mg overencapsulated tablets orally once daily for 12 weeks. |
| OG003 | Placebo | Participants received placebo to match the bempedoic acid + ezetimibe fixed-dose combination (FDC) 180 mg/10 mg tablet, the bempedoic acid 180 mg tablet, or the ezetimibe 10 mg capsule, taken orally, once daily for 12 weeks. |
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| OG003 | Placebo | Participants received placebo to match the bempedoic acid + ezetimibe fixed-dose combination (FDC) 180 mg/10 mg tablet, the bempedoic acid 180 mg tablet, or the ezetimibe 10 mg capsule, taken orally, once daily for 12 weeks. |
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| OG003 | Placebo | Participants received placebo to match the bempedoic acid + ezetimibe fixed-dose combination (FDC) 180 mg/10 mg tablet, the bempedoic acid 180 mg tablet, or the ezetimibe 10 mg capsule, taken orally, once daily for 12 weeks. |
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