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| ID | Type | Description | Link |
|---|---|---|---|
| 2015-004136-36 | EudraCT Number |
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The purpose of this study is to see if ETC-1002 (bempedoic acid) is safe and well-tolerated versus placebo in patients with high cardiovascular risk and elevated LDL cholesterol that is not adequately controlled by their current therapy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ETC-1002 | Experimental | ETC-1002 180 mg/day |
|
| Placebo | Placebo Comparator | Placebo control |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ETC-1002 | Drug | ETC-1002 180 mg tablets taken orally, once per day. Patients remain on ongoing statin therapy (not study provided) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Treatment-emergent Adverse Events (TEAEs) | TEAEs, defined as adverse events (AEs) that began or worsened in severity after the first dose of double-blind study drug and up to 30 days after receiving the last dose of double-blind study drug, were collected and reported. | Up to approximately 52 weeks |
| Percentage of Participants With Adjudicated Major Adverse Cardiovascular Event | TEAEs, defined as AEs that began or worsened in severity after the first dose of double-blind study drug and up to 30 days after receiving the last dose of double-blind study drug, were collected and reported. Cardiovascular events were considered as adverse events of special interest. Treatment-emergent = TE. | Up to approximately 52 weeks |
| Percentage of Participants With the Indicated Event of Special Interest: Creatine Kinase Elevations | TEAEs of special interest (AESIs) were predefined and monitored throughout the study. Creatine kinase elevations were assessed using the following preferred term: Blood creatine phosphokinase increased (system organ class: investigations). | Up to approximately 52 weeks |
| Percentage of Participants With the Indicated Event of Special Interest: Hepatic Disorders | Treatment-emergent AESIs were predefined and monitored throughout the study. TEAEs potentially related to hepatic events were assessed using the following preferred terms and laboratory abnormalities: aspartate aminotransferase (AST) increased, Alanine aminotransferase (ALT) increased, Hepatic enzyme increased, Blood bilirubin increased, liver function test (LFT) abnormal, LFT increased, hepatic enzyme abnormal, transaminases increased, potential Hy's Law cases (PHLC) [AST and (&)/or ALT >3 x upper limit of normal (ULN) with concurrent total bilirubin >2 x ULN], AST and/or ALT >3 x ULN, and total bilirubin >2 x ULN (system organ class: investigations). AST and ALT values were repeated and confirmed. "Repeated and confirmed" was defined as a participant having the last on-study LFT > x ULN, the last on-treatment LFT > x ULN, or LFT > x ULN followed by another LFT > x ULN. |
| 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 values at screening (Week -2) and predose Day 1/Week 0. Percent change from baseline was calculated as: [(LDL-C value at Week 12 minus Baseline value) divided by (Baseline Value)] multiplied by 100. Missing data were imputed with the use of a pattern-mixture model to account for adherence to the trial regimen. Least Square mean= LS mean. Percent change was analyzed using the analysis of covariance (ANCOVA) method, which included treatment, randomization stratum as factors, and baseline value as covariate. |
| Measure | Description | Time Frame |
|---|---|---|
| Percent Change From Baseline to Week 24 in 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 values at screening (Week -2) and predose Day 1/Week 0. Percent change from baseline was calculated as: [(LDL-C value at Week 24 minus Baseline value) divided by (Baseline Value)] multiplied by 100. Missing data were imputed with the use of a pattern-mixture model to account for adherence to the trial regimen. Percent change was analyzed using the ANCOVA method, which included treatment, randomization stratum as factors, and baseline value as covariate. |
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 |
|---|---|---|---|---|---|---|
| Huntsville | Alabama | United States | ||||
| 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. | |
| 24222016 | Background |
| Label | URL |
|---|---|
| World Health Organization Fact Sheet No. 317 | View source |
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The study consisted of 2 periods: a 2-week screening period and a 52-week double-blind, randomized treatment period.
A total of 2230 participants were randomized 2:1 to either bempedoic acid or placebo. One participant was randomized to bempedoic acid treatment, but never received any dose of investigational medicinal product (IMP) i.e. study drug.
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo | During the double-blind treatment period, participants received placebo tablet, once daily by mouth for 52 weeks. In addition, participants received stable background lipid-modifying therapy(ies) including a maximally tolerated statin throughout the study. |
| FG001 | Bempedoic Acid |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| SAP | No | Yes | No | Statistical Analysis Plan | Mar 22, 2018 | Mar 17, 2020 |
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| Placebo | Drug | Matching placebo tablets taken orally, once per day. Patients remain on ongoing statin therapy (not study provided) |
|
| Up to approximately 52 weeks |
| Percentage of Participants With the Indicated Event of Special Interest: Hypoglycemia | Treatment-emergent AESIs were predefined and monitored throughout the study. Hypoglycemia was assessed using the following preferred terms: hypoglycaemia (system organ class: metabolism and nutrition disorders); blood glucose abnormal and blood glucose decreased (system organ class: investigations). The percentage of unique participants is reported in the "Overall hypoglycemia AESIs" category; a participant could have been represented in more than one of the individual hypoglycemia AESIs. | Up to approximately 52 weeks |
| Percentage of Participants With the Indicated Event of Special Interest: Metabolic Acidosis | Treatment-emergent AESIs were predefined and monitored throughout the study. Metabolic acidosis was assessed using the preferred term metabolic acidosis (system organ class: metabolism and nutrition disorders). | Up to approximately 52 weeks |
| Percentage of Participants With the Indicated Event of Special Interest: Muscular Disorder | Treatment-emergent AESIs were predefined and monitored throughout the study. Muscular safety was assessed using the following preferred terms and laboratory abnormalities: myalgia, muscle spasms, pain in extremity, muscular weakness (system organ class: musculoskeletal and connective tissue disorders), and creatine kinase >5 ULN (repeated and confirmed). The percentage of unique participants is reported in the "Overall muscular disorder AESIs" category; a participant could have been represented in more than one of the individual muscular disorder AESIs. | Up to approximately 52 weeks |
| Percentage of Participants With the Indicated Event of Special Interest: Neurocognitive Disorder | Treatment-emergent AESIs were predefined and monitored throughout the study. Neurocognitive disorder was assessed using the following preferred terms: memory impairment, amnesia, and cognitive disorder (system organ class: nervous system disorders); confusional state and disorientation (system organ class: psychiatric disorders). The percentage of unique participants is reported in the "Overall neurocognitive disorder AESIs" category; a participant could have been represented in more than one of the individual neurocognitive disorder AESIs. | Up to approximately 52 weeks |
| Percentage of Participants With the Indicated Event of Special Interest: New Onset or Worsening Diabetes Mellitus | Treatment-emergent AESIs were predefined and monitored throughout the study. New onset or worsening diabetes was assessed using the following preferred terms: type 2 diabetes mellitus, diabetes mellitus, hyperglycaemia, glucose tolerance impaired, diabetes mellitus inadequate control, and impaired fasting glucose (system organ class: metabolism and nutrition disorders); blood glucose increased, glycosylated haemoglobin increased, blood glucose abnormal, and glucose urine present (system organ class: investigations); and glycosuria (system organ class: renal and urinary disorders). The percentage of unique participants is reported in the "Overall new onset/worsening diabetes mellitus AESIs" category; a participant could have been represented in more than one of the individual new onset/worsening diabetes mellitus AESIs. | Up to approximately 52 weeks |
| Percentage of Participants With the Indicated Event of Special Interest: Renal Disorder | Treatment-emergent AESIs were predefined and monitored throughout the study. TEAEs potentially related to renal events were assessed using the following preferred terms: renal failure, renal impairment, acute kidney injury (system organ class: renal and urinary disorders); blood creatinine increased, glomerular filtration rate decreased, blood urea increased, estimated glomerular filtration rate (eGFR) <30 milliliter per minute per 1.73 square meter (ml/min/1.73m^2), and change from baseline in creatinine >1 mg/dL (system organ class: investigations); and gout (system organ class: metabolism and nutrition disorders). The percentage of unique participants is reported in the "Overall renal disorder AESIs" category; a participant could have been represented in more than one of the individual renal disorder AESIs. | Up to approximately 52 weeks |
| Change From Baseline to Week 52 in Uric Acid (Urate) Level | Blood samples were drawn at defined time points during the course of the study to monitor uric acid (urate) levels. | Baseline and Week 52 |
| Change From Baseline to Week 52 in Creatinine Level | Blood samples were drawn at defined time points during the course of the study to monitor creatinine levels. | Baseline and Week 52 |
| Change From Baseline to Week 52 in Hemoglobin Level | Blood samples were drawn at defined time points during the course of the study to monitor hemoglobin levels. | Baseline and Week 52 |
| Baseline; Week 12 |
| Absolute Change From Baseline to Week 12 in 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 values at screening (Week -2) and predose Day 1/Week 0. Absolute change from baseline was calculated as: LDL-C value at Week 12 minus Baseline value. Missing data were imputed with the use of a pattern-mixture model to account for adherence to the trial regimen. | Baseline; Week 12 |
| Baseline; Week 24 |
| 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 values at screening (Week -2) and predose Day 1/Week 0. Percent change from baseline was calculated as: [(non-HDL-C value at Week 12 minus Baseline value) divided by (Baseline Value)] multiplied by 100. Missing data were imputed with the use of a pattern-mixture model to account for adherence to the trial regimen. Percent change was analyzed using the ANCOVA method, which included treatment, randomization stratum as factors, and baseline value as covariate. | 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 values at screening (Week -2) and predose Day 1/Week 0. Percent change from baseline was calculated as: [(TC value at Week 12 minus Baseline value) divided by (Baseline Value)] multiplied by 100. Missing data were imputed with the use of a pattern-mixture model to account for adherence to the trial regimen. Percent change was analyzed using the ANCOVA method, which included treatment, randomization stratum as factors, and baseline value as covariate. | Baseline; Week 12 |
| Percent Change From Baseline to Week 12 in Apolipoprotein B (apoB) | Blood samples were drawn after a minimum 10-hour fast (water was allowed) at pre-specified intervals. Samples were collected and analyzed for apoB. Baseline was defined as the last value prior to first dose of study drug. Percent change from baseline was calculated as: [(apoB value at Week 12 minus Baseline value) divided by (Baseline Value)] multiplied by 100. Missing data were imputed with the use of a pattern-mixture model to account for adherence to the trial regimen. Percent change was analyzed using the ANCOVA method, which included treatment, randomization stratum as factors, and baseline value as covariate. | Baseline; Week 12 |
| 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 last value prior to first dose of study drug. Percent change from baseline was calculated as: [(hsCRP value at Week 12 minus Baseline value) divided by (Baseline Value)] multiplied by 100. Observed data was used for the analysis, no imputation for the missing data was performed. Percent change was analyzed using the ANCOVA method, which included treatment, randomization stratum as factors, and baseline value as covariate. | Baseline; Week 12 |
| Percent Change From Baseline to Week 52 in 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 values at screening (Week -2) and predose Day 1/Week 0. Percent change from baseline was calculated as: [(LDL-C value at Week 52 minus Baseline value) divided by (Baseline Value)] multiplied by 100. Observed data was used for the analysis, no imputation for the missing data was performed. Percent change was analyzed using the ANCOVA method, which included treatment, randomization stratum as factors, and baseline value as covariate. | Baseline; Week 52 |
| Percent Change From Baseline to Week 24 in 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 values at screening (Week -2) and predose Day 1/Week 0. Percent change from baseline was calculated as: [(non-HDL-C value at Week 24 minus Baseline value) divided by (Baseline Value)] multiplied by 100. Observed data was used for the analysis, no imputation for the missing data was performed. | Baseline; Week 24 |
| Percent Change From Baseline to Week 52 in 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 values at screening (Week -2) and predose Day 1/Week 0. Percent change from baseline was calculated as: [(non-HDL-C value at Week 52 minus Baseline value) divided by (Baseline Value)] multiplied by 100. Observed data was used for the analysis, no imputation for the missing data was performed. | Baseline; Week 52 |
| Percent Change From Baseline to Week 24 in 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 values at screening (Week -2) and predose Day 1/Week 0. Percent change from baseline was calculated as: [(TC value at Week 24 minus Baseline value) divided by (Baseline Value)] multiplied by 100. Observed data was used for the analysis, no imputation for the missing data was performed. | Baseline; Week 24 |
| Percent Change From Baseline to Week 52 in 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 values at screening (Week -2) and predose Day 1/Week 0. Percent change from baseline was calculated as: [(TC value at Week 52 minus Baseline value) divided by (Baseline Value)] multiplied by 100. Observed data was used for the analysis, no imputation for the missing data was performed. | Baseline; Week 52 |
| Percent Change From Baseline to Week 24 in apoB | Blood samples were drawn after a minimum 10-hour fast (water was allowed) at pre-specified intervals. Samples were collected and analyzed for apoB. Baseline was defined as the last value prior to first dose of study drug. Percent change from baseline was calculated as: [(apoB value at Week 24 minus Baseline value) divided by (Baseline Value)] multiplied by 100. Observed data was used for the analysis, no imputation for the missing data was performed | Baseline; Week 24 |
| Percent Change From Baseline to Week 52 in apoB | Blood samples were drawn after a minimum 10-hour fast (water was allowed) at pre-specified intervals. Samples were collected and analyzed for apoB. Baseline was defined as the last value prior to first dose of study drug. Percent change from baseline was calculated as: [(apoB value at Week 52 minus Baseline value) divided by (Baseline Value)] multiplied by 100. Observed data was used for the analysis, no imputation for the missing data was performed. | Baseline; Week 52 |
| Percent Change From Baseline to Week 24 in 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 last value prior to first dose of study drug. Percent change from baseline was calculated as: [(hsCRP value at Week 24 minus Baseline value) divided by (Baseline Value)] multiplied by 100. Observed data was used for the analysis, no imputation for the missing data was performed. | Baseline; Week 24 |
| Percent Change From Baseline to Week 52 in 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 last value prior to first dose of study drug. Percent change from baseline was calculated as: [(hsCRP value at Week 52 minus Baseline value) divided by (Baseline Value)] multiplied by 100. Observed data was used for the analysis, no imputation for the missing data was performed. | Baseline; Week 52 |
| Percentage of Participants Achieving LDL-C <70 mg/dL at Week 12, 24, and 52 | The percentage of participants who achieved lowering in lipid values of LDL-C below 70 mg/dL have been reported. Baseline was defined as the mean of the values at screening (Week -2) and predose Day 1/Week 0. Observed data was used for the analysis, no imputation for the missing data was performed. | Week 12, Week 24, and Week 52 |
| Cottonwood |
| Arizona |
| United States |
| Phoenix | Arizona | United States |
| Canoga Park | California | United States |
| Santa Rosa | California | United States |
| Bridgeport | Connecticut | United States |
| Hartford | Connecticut | United States |
| Atlantis | Florida | United States |
| Boca Raton | Florida | United States |
| Crestview | Florida | United States |
| Crystal River | Florida | United States |
| Daytona Beach | Florida | United States |
| Lake Worth | Florida | United States |
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| Tampa | Florida | United States |
| Park Ridge | Illinois | United States |
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| Covington | Kentucky | United States |
| Louisville | Kentucky | United States |
| Minden | Louisiana | United States |
| Monroe | Louisiana | United States |
| Shreveport | Louisiana | United States |
| Auburn | Maine | United States |
| Midland | Michigan | United States |
| Saginaw | Michigan | United States |
| Saint Cloud | Minnesota | United States |
| Tupelo | Mississippi | United States |
| Jefferson City | Missouri | United States |
| Nashua | New Hampshire | United States |
| Bridgewater | New Jersey | United States |
| Cary | North Carolina | United States |
| Mount Airy | North Carolina | United States |
| Raleigh | North Carolina | United States |
| Rocky Mount | North Carolina | United States |
| Wilmington | North Carolina | United States |
| Cincinnati | Ohio | United States |
| Sandusky | Ohio | United States |
| Willoughby | Ohio | United States |
| Hillsboro | Oregon | United States |
| Fort Worth | Texas | United States |
| Houston | Texas | United States |
| Katy | Texas | United States |
| Kingwood | Texas | United States |
| Orem | Utah | United States |
| Richmond | Virginia | United States |
| Puyallup | Washington | United States |
| Tacoma | Washington | United States |
| Vancouver | British Columbia | Canada |
| Victoria | British Columbia | Canada |
| Gatineau | Ontario | Canada |
| Mississauga | Ontario | Canada |
| Oshawa | Ontario | Canada |
| Peterborough | Ontario | Canada |
| Scarborough Village | Ontario | Canada |
| Chicoutimi | Quebec | Canada |
| Gatineau | Quebec | Canada |
| Longueuil | Quebec | Canada |
| Montreal | Quebec | Canada |
| Québec | Quebec | Canada |
| Saint-Charles-Borromée | Quebec | Canada |
| Saint-Jean-sur-Richelieu | Quebec | Canada |
| Berlin | Germany |
| Bochum | Germany |
| Dresden | Germany |
| Essen | Germany |
| Frankfurt | Germany |
| Leipzig | Germany |
| München | Germany |
| Amsterdam | Netherlands |
| Arnhem | Netherlands |
| Eindhoven | Netherlands |
| Goes | Netherlands |
| Groningen | Netherlands |
| Hardenberg | Netherlands |
| Leiden | Netherlands |
| Rotterdam | Netherlands |
| Tilburg | Netherlands |
| Venlo | Netherlands |
| Zutphen | Netherlands |
| Gdansk | Poland |
| Gdynia | Poland |
| Katowice | Poland |
| Krakow | Poland |
| Lodz | Poland |
| Lowicz | Poland |
| Poznan | Poland |
| Puławy | Poland |
| Torun | Poland |
| Wroclaw | Poland |
| Bexhill-on-Sea | United Kingdom |
| Birmingham | United Kingdom |
| Cardiff | United Kingdom |
| Chesterfield | United Kingdom |
| Chichester | United Kingdom |
| Chippenham | United Kingdom |
| Chorley | United Kingdom |
| Glasgow | United Kingdom |
| Hexham | United Kingdom |
| Hull | United Kingdom |
| Ipswich | United Kingdom |
| Liverpool | United Kingdom |
| Manchester | United Kingdom |
| Reading | United Kingdom |
| 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. |
| 21600525 | Background | Goldberg AC, Hopkins PN, Toth PP, Ballantyne CM, Rader DJ, Robinson JG, Daniels SR, Gidding SS, de Ferranti SD, Ito MK, McGowan MP, Moriarty PM, Cromwell WC, Ross JL, Ziajka PE; National Lipid Association Expert Panel on Familial Hypercholesterolemia. Familial hypercholesterolemia: screening, diagnosis and management of pediatric and adult patients: clinical guidance from the National Lipid Association Expert Panel on Familial Hypercholesterolemia. J Clin Lipidol. 2011 Jun;5(3 Suppl):S1-8. doi: 10.1016/j.jacl.2011.04.003. Epub 2011 Apr 12. |
| 18537526 | Background | Pollex RL, Joy TR, Hegele RA. Emerging antidyslipidemic drugs. Expert Opin Emerg Drugs. 2008 Jun;13(2):363-81. doi: 10.1517/14728214.13.2.363. |
| 11535564 | Background | Sharrett AR, Ballantyne CM, Coady SA, Heiss G, Sorlie PD, Catellier D, Patsch W; Atherosclerosis Risk in Communities Study Group. Coronary heart disease prediction from lipoprotein cholesterol levels, triglycerides, lipoprotein(a), apolipoproteins A-I and B, and HDL density subfractions: The Atherosclerosis Risk in Communities (ARIC) Study. Circulation. 2001 Sep 4;104(10):1108-13. doi: 10.1161/hc3501.095214. |
| 30865796 | Result | Ray KK, Bays HE, Catapano AL, Lalwani ND, Bloedon LT, Sterling LR, Robinson PL, Ballantyne CM; CLEAR Harmony Trial. Safety and Efficacy of Bempedoic Acid to Reduce LDL Cholesterol. N Engl J Med. 2019 Mar 14;380(11):1022-1032. doi: 10.1056/NEJMoa1803917. |
| 36813656 | Derived | Ridker PM, Lei L, Ray KK, Ballantyne CM, Bradwin G, Rifai N. Effects of bempedoic acid on CRP, IL-6, fibrinogen and lipoprotein(a) in patients with residual inflammatory risk: A secondary analysis of the CLEAR harmony trial. J Clin Lipidol. 2023 Mar-Apr;17(2):297-302. doi: 10.1016/j.jacl.2023.02.002. Epub 2023 Feb 14. |
| 35916348 | Derived | Ballantyne CM, Bays HE, Louie MJ, Smart J, Zhang Y, Ray KK. Factors Associated With Enhanced Low-Density Lipoprotein Cholesterol Lowering With Bempedoic Acid. J Am Heart Assoc. 2022 Aug 2;11(15):e024531. doi: 10.1161/JAHA.121.024531. Epub 2022 Aug 2. |
| 32609313 | Derived | Banach M, Duell PB, Gotto AM Jr, Laufs U, Leiter LA, Mancini GBJ, Ray KK, Flaim J, Ye Z, Catapano AL. Association of Bempedoic Acid Administration With Atherogenic Lipid Levels in Phase 3 Randomized Clinical Trials of Patients With Hypercholesterolemia. JAMA Cardiol. 2020 Oct 1;5(10):1124-1135. doi: 10.1001/jamacardio.2020.2314. |
| Familial Hypercholesterolemia Foundation | View source |
| National Organization for Rare Disorders - Familial Hypercholesterolemia | View source |
During the double-blind treatment period, participants received bempedoic acid 180 mg tablet, once daily by mouth for 52 weeks. In addition, participants received stable background lipid-modifying therapy(ies) including a maximally tolerated statin throughout the study. |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Placebo | During the double-blind treatment period, participants received placebo tablet, once daily by mouth for 52 weeks. In addition, participants received stable background lipid-modifying therapy(ies) including a maximally tolerated statin throughout the study. |
| BG001 | Bempedoic Acid | During the double-blind treatment period, participants received bempedoic acid 180 mg tablet, once daily by mouth for 52 weeks. In addition, participants received stable background lipid-modifying therapy(ies) including a maximally tolerated statin throughout the study. |
| BG002 | 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 |
| ||||||||||||||||
| Cardiovascular history: atherosclerotic cardiovascular disease (ASCVD) | Count of Participants | Participants |
| ||||||||||||||||
| Cardiovascular history: heterozygous familial hypercholesterolemia (HeFH) | Count of Participants | Participants |
| ||||||||||||||||
| History of diabetes | Count of Participants | Participants |
| ||||||||||||||||
| History of hypertension | Count of Participants | Participants |
| ||||||||||||||||
| Concomitant lipid-modifying therapy (LMT): Statin | Concomitant medications are defined as medications that were ongoing at the time of double-blind study drug initiation or new medications that started post double-blind study drug initiation and within 30 days following the date of the last dose of study drug. | Count of Participants | Participants |
| |||||||||||||||
| Concomitant LMT: Ezetimibe | Concomitant medications are defined as medications that were ongoing at the time of double-blind study drug initiation or new medications that started post double-blind study drug initiation and within 30 days following the date of the last dose of study drug. | Count of Participants | Participants |
| |||||||||||||||
| Concomitant LMT: Fibrate | Concomitant medications are defined as medications that were ongoing at the time of double-blind study drug initiation or new medications that started post double-blind study drug initiation and within 30 days following the date of the last dose of study drug. | Count of Participants | Participants |
| |||||||||||||||
| Concomitant LMT: None | Concomitant medications are defined as medications that were ongoing at the time of double-blind study drug initiation or new medications that started post double-blind study drug initiation and within 30 days following the date of the last dose of study drug. | Count of Participants | Participants |
| |||||||||||||||
| Baseline statin intensity | Baseline statin intensity were based on stratification at randomization. Low-intensity statins: simvastatin 10 milligrams (mg); pravastatin 10-20 mg; lovastatin 20 mg; fluvastatin 20-40 mg; pitavastatin 1 mg. Moderate-intensity statins: atorvastatin 10-20 mg; rosuvastatin 5-10 mg; simvastatin 20 mg; pravastatin 40-80 mg; lovastatin 40 mg; fluvastatin XL 80 mg; fluvastatin 40 mg twice a day; pitavastatin 2-4 mg. High-intensity statins: atorvastatin 40-80 mg; rosuvastatin 20-40 mg. | Count of Participants | Participants |
| |||||||||||||||
| Estimated glomerular filtration rate (eGFR) | milliliter per minute per 1.73 square meter = ml/min/1.73m^2 | Count of Participants | Participants |
| |||||||||||||||
| Total cholesterol (TC) | Baseline was defined as the mean of the values at screening and predose Day 1/Week 0 (Visit T1). | Mean | Standard Deviation | mg/dL |
| ||||||||||||||
| Low-density lipoprotein cholesterol (LDL-C) | Baseline was defined as the mean of the values at screening and predose Day 1/Week 0 (Visit T1). | Mean | Standard Deviation | mg/dL |
| ||||||||||||||
| High-density lipoprotein cholesterol (HDL-C) | Baseline was defined as the mean of the values at screening and predose Day 1/Week 0 (Visit T1). | Mean | Standard Deviation | mg/dL |
| ||||||||||||||
| Triglycerides (TG) | Baseline was defined as the mean of the values at screening and predose Day 1/Week 0 (Visit T1). | Median | Inter-Quartile Range | mg/dL |
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| Non-high-density lipoprotein cholesterol (non-HDL-C) | Baseline was defined as the mean of the values at screening and predose Day 1/Week 0 (Visit T1). | Mean | Standard Deviation | mg/dL |
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| Apolipoprotein B (apoB) | Baseline was defined as the last value prior to first dose of study drug. | Mean | Standard Deviation | mg/dL |
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| High-sensitivity C-reactive protein (hsCRP) | Baseline was defined as the last value prior to the first dose of study drug. | Median | Inter-Quartile Range | mg/L |
|
| 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 | Percentage of Participants With Treatment-emergent Adverse Events (TEAEs) | TEAEs, defined as adverse events (AEs) that began or worsened in severity after the first dose of double-blind study drug and up to 30 days after receiving the last dose of double-blind study drug, were collected and reported. | Safety Population: all randomized participants who received at least 1 dose of investigational medicinal product. Participants were included in the treatment group that they received, regardless of their randomized treatment. | Posted | Number | percentage of participants | Up to approximately 52 weeks |
|
|
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| Primary | Percentage of Participants With Adjudicated Major Adverse Cardiovascular Event | TEAEs, defined as AEs that began or worsened in severity after the first dose of double-blind study drug and up to 30 days after receiving the last dose of double-blind study drug, were collected and reported. Cardiovascular events were considered as adverse events of special interest. Treatment-emergent = TE. | Safety Population | Posted | Number | percentage of participants | Up to approximately 52 weeks |
|
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| Primary | Percentage of Participants With the Indicated Event of Special Interest: Creatine Kinase Elevations | TEAEs of special interest (AESIs) were predefined and monitored throughout the study. Creatine kinase elevations were assessed using the following preferred term: Blood creatine phosphokinase increased (system organ class: investigations). | Safety Population | Posted | Number | percentage of participants | Up to approximately 52 weeks |
|
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| Primary | Percentage of Participants With the Indicated Event of Special Interest: Hepatic Disorders | Treatment-emergent AESIs were predefined and monitored throughout the study. TEAEs potentially related to hepatic events were assessed using the following preferred terms and laboratory abnormalities: aspartate aminotransferase (AST) increased, Alanine aminotransferase (ALT) increased, Hepatic enzyme increased, Blood bilirubin increased, liver function test (LFT) abnormal, LFT increased, hepatic enzyme abnormal, transaminases increased, potential Hy's Law cases (PHLC) [AST and (&)/or ALT >3 x upper limit of normal (ULN) with concurrent total bilirubin >2 x ULN], AST and/or ALT >3 x ULN, and total bilirubin >2 x ULN (system organ class: investigations). AST and ALT values were repeated and confirmed. "Repeated and confirmed" was defined as a participant having the last on-study LFT > x ULN, the last on-treatment LFT > x ULN, or LFT > x ULN followed by another LFT > x ULN. | Safety Population. The percentage of unique participants is reported in the "Overall hepatic disorder AESIs" category; a participant could have been represented in more than one of the individual hepatic disorder AESIs. | Posted | Number | percentage of participants | Up to approximately 52 weeks |
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| Primary | Percentage of Participants With the Indicated Event of Special Interest: Hypoglycemia | Treatment-emergent AESIs were predefined and monitored throughout the study. Hypoglycemia was assessed using the following preferred terms: hypoglycaemia (system organ class: metabolism and nutrition disorders); blood glucose abnormal and blood glucose decreased (system organ class: investigations). The percentage of unique participants is reported in the "Overall hypoglycemia AESIs" category; a participant could have been represented in more than one of the individual hypoglycemia AESIs. | Safety Population | Posted | Number | percentage of participants | Up to approximately 52 weeks |
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| Primary | Percentage of Participants With the Indicated Event of Special Interest: Metabolic Acidosis | Treatment-emergent AESIs were predefined and monitored throughout the study. Metabolic acidosis was assessed using the preferred term metabolic acidosis (system organ class: metabolism and nutrition disorders). | Safety Population | Posted | Number | percentage of participants | Up to approximately 52 weeks |
|
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| Primary | Percentage of Participants With the Indicated Event of Special Interest: Muscular Disorder | Treatment-emergent AESIs were predefined and monitored throughout the study. Muscular safety was assessed using the following preferred terms and laboratory abnormalities: myalgia, muscle spasms, pain in extremity, muscular weakness (system organ class: musculoskeletal and connective tissue disorders), and creatine kinase >5 ULN (repeated and confirmed). The percentage of unique participants is reported in the "Overall muscular disorder AESIs" category; a participant could have been represented in more than one of the individual muscular disorder AESIs. | Safety Population | Posted | Number | percentage of participants | Up to approximately 52 weeks |
| ||||||||||||||||||||||||||||||||||||||
| Primary | Percentage of Participants With the Indicated Event of Special Interest: Neurocognitive Disorder | Treatment-emergent AESIs were predefined and monitored throughout the study. Neurocognitive disorder was assessed using the following preferred terms: memory impairment, amnesia, and cognitive disorder (system organ class: nervous system disorders); confusional state and disorientation (system organ class: psychiatric disorders). The percentage of unique participants is reported in the "Overall neurocognitive disorder AESIs" category; a participant could have been represented in more than one of the individual neurocognitive disorder AESIs. | Safety Population | Posted | Number | percentage of participants | Up to approximately 52 weeks |
| ||||||||||||||||||||||||||||||||||||||
| Primary | Percentage of Participants With the Indicated Event of Special Interest: New Onset or Worsening Diabetes Mellitus | Treatment-emergent AESIs were predefined and monitored throughout the study. New onset or worsening diabetes was assessed using the following preferred terms: type 2 diabetes mellitus, diabetes mellitus, hyperglycaemia, glucose tolerance impaired, diabetes mellitus inadequate control, and impaired fasting glucose (system organ class: metabolism and nutrition disorders); blood glucose increased, glycosylated haemoglobin increased, blood glucose abnormal, and glucose urine present (system organ class: investigations); and glycosuria (system organ class: renal and urinary disorders). The percentage of unique participants is reported in the "Overall new onset/worsening diabetes mellitus AESIs" category; a participant could have been represented in more than one of the individual new onset/worsening diabetes mellitus AESIs. | Safety Population | Posted | Number | percentage of participants | Up to approximately 52 weeks |
| ||||||||||||||||||||||||||||||||||||||
| Primary | Percentage of Participants With the Indicated Event of Special Interest: Renal Disorder | Treatment-emergent AESIs were predefined and monitored throughout the study. TEAEs potentially related to renal events were assessed using the following preferred terms: renal failure, renal impairment, acute kidney injury (system organ class: renal and urinary disorders); blood creatinine increased, glomerular filtration rate decreased, blood urea increased, estimated glomerular filtration rate (eGFR) <30 milliliter per minute per 1.73 square meter (ml/min/1.73m^2), and change from baseline in creatinine >1 mg/dL (system organ class: investigations); and gout (system organ class: metabolism and nutrition disorders). The percentage of unique participants is reported in the "Overall renal disorder AESIs" category; a participant could have been represented in more than one of the individual renal disorder AESIs. | Safety Population | Posted | Number | percentage of participants | Up to approximately 52 weeks |
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| Primary | Change From Baseline to Week 52 in Uric Acid (Urate) Level | Blood samples were drawn at defined time points during the course of the study to monitor uric acid (urate) levels. | Safety Population. Only participants with available data were analyzed. | Posted | Mean | Standard Deviation | milligrams per deciliter (mg/dL) | Baseline and Week 52 |
|
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| Primary | Change From Baseline to Week 52 in Creatinine Level | Blood samples were drawn at defined time points during the course of the study to monitor creatinine levels. | Safety Population. Only participants with available data were analyzed. | Posted | Mean | Standard Deviation | mg/dL | Baseline and Week 52 |
|
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| Primary | Change From Baseline to Week 52 in Hemoglobin Level | Blood samples were drawn at defined time points during the course of the study to monitor hemoglobin levels. | Safety Population. Only participants with available data were analyzed. | Posted | Mean | Standard Deviation | grams per deciliter (g/dL) | Baseline and Week 52 |
|
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| Secondary | 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 values at screening (Week -2) and predose Day 1/Week 0. Percent change from baseline was calculated as: [(LDL-C value at Week 12 minus Baseline value) divided by (Baseline Value)] multiplied by 100. Missing data were imputed with the use of a pattern-mixture model to account for adherence to the trial regimen. Least Square mean= LS mean. Percent change was analyzed using the analysis of covariance (ANCOVA) method, which included treatment, randomization stratum as factors, and baseline value as covariate. | Full Analysis Set: all randomized participants | Posted | Least Squares Mean | Standard Error | percent change | Baseline; Week 12 |
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| Secondary | Absolute Change From Baseline to Week 12 in 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 values at screening (Week -2) and predose Day 1/Week 0. Absolute change from baseline was calculated as: LDL-C value at Week 12 minus Baseline value. Missing data were imputed with the use of a pattern-mixture model to account for adherence to the trial regimen. | Full Analysis Set. Only participants with available data were analyzed. | Posted | Mean | Standard Deviation | mg/dL | Baseline; Week 12 |
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| Other Pre-specified | Percent Change From Baseline to Week 24 in 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 values at screening (Week -2) and predose Day 1/Week 0. Percent change from baseline was calculated as: [(LDL-C value at Week 24 minus Baseline value) divided by (Baseline Value)] multiplied by 100. Missing data were imputed with the use of a pattern-mixture model to account for adherence to the trial regimen. Percent change was analyzed using the ANCOVA method, which included treatment, randomization stratum as factors, and baseline value as covariate. | Full Analysis Set | Posted | Least Squares Mean | Standard Error | percent change | Baseline; Week 24 |
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| Other Pre-specified | 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 values at screening (Week -2) and predose Day 1/Week 0. Percent change from baseline was calculated as: [(non-HDL-C value at Week 12 minus Baseline value) divided by (Baseline Value)] multiplied by 100. Missing data were imputed with the use of a pattern-mixture model to account for adherence to the trial regimen. Percent change was analyzed using the ANCOVA method, which included treatment, randomization stratum as factors, and baseline value as covariate. | Full Analysis Set | Posted | Least Squares Mean | Standard Error | percent change | Baseline; Week 12 |
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| Other Pre-specified | 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 values at screening (Week -2) and predose Day 1/Week 0. Percent change from baseline was calculated as: [(TC value at Week 12 minus Baseline value) divided by (Baseline Value)] multiplied by 100. Missing data were imputed with the use of a pattern-mixture model to account for adherence to the trial regimen. Percent change was analyzed using the ANCOVA method, which included treatment, randomization stratum as factors, and baseline value as covariate. | Full Analysis Set | Posted | Least Squares Mean | Standard Error | percent change | Baseline; Week 12 |
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| Other Pre-specified | Percent Change From Baseline to Week 12 in Apolipoprotein B (apoB) | Blood samples were drawn after a minimum 10-hour fast (water was allowed) at pre-specified intervals. Samples were collected and analyzed for apoB. Baseline was defined as the last value prior to first dose of study drug. Percent change from baseline was calculated as: [(apoB value at Week 12 minus Baseline value) divided by (Baseline Value)] multiplied by 100. Missing data were imputed with the use of a pattern-mixture model to account for adherence to the trial regimen. Percent change was analyzed using the ANCOVA method, which included treatment, randomization stratum as factors, and baseline value as covariate. | Full Analysis Set. Only participants with available data were analyzed. | Posted | Least Squares Mean | Standard Error | percent change | Baseline; Week 12 |
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| Other Pre-specified | 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 last value prior to first dose of study drug. Percent change from baseline was calculated as: [(hsCRP value at Week 12 minus Baseline value) divided by (Baseline Value)] multiplied by 100. Observed data was used for the analysis, no imputation for the missing data was performed. Percent change was analyzed using the ANCOVA method, which included treatment, randomization stratum as factors, and baseline value as covariate. | Full Analysis Set. Only participants with available data were analyzed. | Posted | Least Squares Mean | Standard Error | percent change | Baseline; Week 12 |
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| Other Pre-specified | Percent Change From Baseline to Week 52 in 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 values at screening (Week -2) and predose Day 1/Week 0. Percent change from baseline was calculated as: [(LDL-C value at Week 52 minus Baseline value) divided by (Baseline Value)] multiplied by 100. Observed data was used for the analysis, no imputation for the missing data was performed. Percent change was analyzed using the ANCOVA method, which included treatment, randomization stratum as factors, and baseline value as covariate. | Full Analysis Set. Only participants with available data were analyzed. | Posted | Least Squares Mean | Standard Error | percent change | Baseline; Week 52 |
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| Other Pre-specified | Percent Change From Baseline to Week 24 in 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 values at screening (Week -2) and predose Day 1/Week 0. Percent change from baseline was calculated as: [(non-HDL-C value at Week 24 minus Baseline value) divided by (Baseline Value)] multiplied by 100. Observed data was used for the analysis, no imputation for the missing data was performed. | Full Analysis Set. Only participants with available data were analyzed. | Posted | Mean | Standard Deviation | percent change | Baseline; Week 24 |
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| Other Pre-specified | Percent Change From Baseline to Week 52 in 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 values at screening (Week -2) and predose Day 1/Week 0. Percent change from baseline was calculated as: [(non-HDL-C value at Week 52 minus Baseline value) divided by (Baseline Value)] multiplied by 100. Observed data was used for the analysis, no imputation for the missing data was performed. | Full Analysis Set. Only participants with available data were analyzed. | Posted | Mean | Standard Deviation | percent change | Baseline; Week 52 |
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| Other Pre-specified | Percent Change From Baseline to Week 24 in 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 values at screening (Week -2) and predose Day 1/Week 0. Percent change from baseline was calculated as: [(TC value at Week 24 minus Baseline value) divided by (Baseline Value)] multiplied by 100. Observed data was used for the analysis, no imputation for the missing data was performed. | Full Analysis Set. Only participants with available data were analyzed. | Posted | Mean | Standard Deviation | percent change | Baseline; Week 24 |
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| Other Pre-specified | Percent Change From Baseline to Week 52 in 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 values at screening (Week -2) and predose Day 1/Week 0. Percent change from baseline was calculated as: [(TC value at Week 52 minus Baseline value) divided by (Baseline Value)] multiplied by 100. Observed data was used for the analysis, no imputation for the missing data was performed. | Full Analysis Set. Only participants with available data were analyzed. | Posted | Mean | Standard Deviation | percent change | Baseline; Week 52 |
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| Other Pre-specified | Percent Change From Baseline to Week 24 in apoB | Blood samples were drawn after a minimum 10-hour fast (water was allowed) at pre-specified intervals. Samples were collected and analyzed for apoB. Baseline was defined as the last value prior to first dose of study drug. Percent change from baseline was calculated as: [(apoB value at Week 24 minus Baseline value) divided by (Baseline Value)] multiplied by 100. Observed data was used for the analysis, no imputation for the missing data was performed | Full Analysis Set. Only participants with available data were analyzed. | Posted | Mean | Standard Deviation | percent change | Baseline; Week 24 |
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| Other Pre-specified | Percent Change From Baseline to Week 52 in apoB | Blood samples were drawn after a minimum 10-hour fast (water was allowed) at pre-specified intervals. Samples were collected and analyzed for apoB. Baseline was defined as the last value prior to first dose of study drug. Percent change from baseline was calculated as: [(apoB value at Week 52 minus Baseline value) divided by (Baseline Value)] multiplied by 100. Observed data was used for the analysis, no imputation for the missing data was performed. | Full Analysis Set. Only participants with available data were analyzed. | Posted | Mean | Standard Deviation | percent change | Baseline; Week 52 |
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| Other Pre-specified | Percent Change From Baseline to Week 24 in 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 last value prior to first dose of study drug. Percent change from baseline was calculated as: [(hsCRP value at Week 24 minus Baseline value) divided by (Baseline Value)] multiplied by 100. Observed data was used for the analysis, no imputation for the missing data was performed. | Full Analysis Set. Only participants with available data were analyzed. | Posted | Median | Inter-Quartile Range | percent change | Baseline; Week 24 |
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| Other Pre-specified | Percent Change From Baseline to Week 52 in 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 last value prior to first dose of study drug. Percent change from baseline was calculated as: [(hsCRP value at Week 52 minus Baseline value) divided by (Baseline Value)] multiplied by 100. Observed data was used for the analysis, no imputation for the missing data was performed. | Full Analysis Set. Only participants with available data were analyzed. | Posted | Median | Inter-Quartile Range | percent change | Baseline; Week 52 |
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| Other Pre-specified | Percentage of Participants Achieving LDL-C <70 mg/dL at Week 12, 24, and 52 | The percentage of participants who achieved lowering in lipid values of LDL-C below 70 mg/dL have been reported. Baseline was defined as the mean of the values at screening (Week -2) and predose Day 1/Week 0. Observed data was used for the analysis, no imputation for the missing data was performed. | Full Analysis Set. Only participants with available data were analyzed. | Posted | Number | Percentage of participants | Week 12, Week 24, and Week 52 |
|
|
Up to approximately 52 weeks
Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began or worsened in severity after the first dose of double-blind study drug and up to 30 days after receiving the last dose of double-blind study drug, were collected and reported.
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 | During the double-blind treatment period, participants received bempedoic acid 180 mg tablet, once daily by mouth for 52 weeks. In addition, participants received stable background lipid-modifying therapy(ies) including a maximally tolerated statin throughout the study. | 13 | 1,487 | 216 | 1,487 | 792 | 1,487 |
| EG001 | Placebo | During the double-blind treatment period, participants received placebo tablet, once daily by mouth for 52 weeks. In addition, participants received stable background lipid-modifying therapy(ies) including a maximally tolerated statin throughout the study. | 2 | 742 | 104 | 742 | 381 | 742 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Acute left ventricular failure | Cardiac disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Acute coronary syndrome | Cardiac disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Acute myocardial infarction | Cardiac disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Angina pectoris | Cardiac disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Angina unstable | Cardiac disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Aortic valve incompetence | Cardiac disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Arrhythmia | Cardiac disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Arteriospasm coronary | Cardiac disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Atrial flutter | Cardiac disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Atrial tachycardia | Cardiac disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Atrioventricular block complete | Cardiac disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Atrioventricular block second degree | Cardiac disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Cardiac arrest | Cardiac disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Bradycardia | Cardiac disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Cardiac failure | Cardiac disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Cardiac failure acute | 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 |
| |
| Hypertensive heart disease | Cardiac disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Ischaemic cardiomyopathy | Cardiac disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Left ventricular dilatation | Cardiac disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Myocardial ischaemia | Cardiac disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Myocardial infarction | Cardiac disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Pericarditis | Cardiac disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Sinus node dysfunction | Cardiac disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Supraventricular tachycardia | Cardiac disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Ventricular fibrillation | Cardiac disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Myotonic dystrophy | Congenital, familial and genetic disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Ventricular tachycardia | Cardiac disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Goitre | Endocrine disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Hyperparathyroidism primary | Endocrine disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Retinal detachment | Eye disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Cataract | Eye disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Abdominal hernia | Gastrointestinal disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Diverticular perforation | Gastrointestinal disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Duodenal ulcer | Gastrointestinal disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Enteritis | Gastrointestinal disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Gastritis | Gastrointestinal disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Inguinal hernia | Gastrointestinal disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Internal hernia | Gastrointestinal disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Large intestine polyp | Gastrointestinal disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Mallory-Weiss syndrome | Gastrointestinal disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Obstructive pancreatitis | Gastrointestinal disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Pancreatitis acute | Gastrointestinal disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Pancreatic pseudocyst | Gastrointestinal disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Rectal haemorrhage | Gastrointestinal disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Pancreatitis relapsing | Gastrointestinal disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Umbilical hernia | Gastrointestinal disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Small intestinal obstruction | Gastrointestinal disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Upper gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Chest discomfort | General disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Chest pain | General disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Death | General disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Eye complication associated with device | General disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Granuloma | General disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Gait disturbance | General disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Hernia | General disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Multiple organ dysfunction syndrome | General disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Pelvic mass | General disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Non-cardiac chest pain | General disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Vascular stent restenosis | General disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Cholecystitis acute | Hepatobiliary disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Cholecystitis | Hepatobiliary disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Cholelithiasis | Hepatobiliary disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Jaundice | Hepatobiliary disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Portal vein thrombosis | Hepatobiliary disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Immune system disorder | Immune system disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Abscess jaw | Infections and infestations | MedDRA 20.1 | Systematic Assessment |
| |
| Abdominal sepsis | Infections and infestations | MedDRA 20.1 | Systematic Assessment |
| |
| Appendicitis | Infections and infestations | MedDRA 20.1 | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA 20.1 | Systematic Assessment |
| |
| Campylobacter gastroenteritis | Infections and infestations | MedDRA 20.1 | Systematic Assessment |
| |
| Clostridium difficile infection | Infections and infestations | MedDRA 20.1 | Systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA 20.1 | Systematic Assessment |
| |
| Erysipelas | Infections and infestations | MedDRA 20.1 | Systematic Assessment |
| |
| Diverticulitis | Infections and infestations | MedDRA 20.1 | Systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA 20.1 | Systematic Assessment |
| |
| Helicobacter infection | Infections and infestations | MedDRA 20.1 | Systematic Assessment |
| |
| Implant site infection | Infections and infestations | MedDRA 20.1 | Systematic Assessment |
| |
| Infected bite | Infections and infestations | MedDRA 20.1 | Systematic Assessment |
| |
| Infective aneurysm | Infections and infestations | MedDRA 20.1 | Systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA 20.1 | Systematic Assessment |
| |
| Localised infection | Infections and infestations | MedDRA 20.1 | Systematic Assessment |
| |
| Medical device site joint infection | Infections and infestations | MedDRA 20.1 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 20.1 | Systematic Assessment |
| |
| Peritonitis | Infections and infestations | MedDRA 20.1 | Systematic Assessment |
| |
| Pulmonary sepsis | Infections and infestations | MedDRA 20.1 | Systematic Assessment |
| |
| Pyelonephritis | Infections and infestations | MedDRA 20.1 | Systematic Assessment |
| |
| Respiratory tract infection | Infections and infestations | MedDRA 20.1 | Systematic Assessment |
| |
| Salmonella bacteraemia | Infections and infestations | MedDRA 20.1 | Systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA 20.1 | Systematic Assessment |
| |
| Skin infection | Infections and infestations | MedDRA 20.1 | Systematic Assessment |
| |
| Septic shock | Infections and infestations | MedDRA 20.1 | Systematic Assessment |
| |
| Staphylococcal osteomyelitis | Infections and infestations | MedDRA 20.1 | Systematic Assessment |
| |
| Tonsillitis bacterial | Infections and infestations | MedDRA 20.1 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 20.1 | Systematic Assessment |
| |
| Viral infection | Infections and infestations | MedDRA 20.1 | Systematic Assessment |
| |
| Wound infection | Infections and infestations | MedDRA 20.1 | Systematic Assessment |
| |
| Anaemia postoperative | Injury, poisoning and procedural complications | MedDRA 20.1 | Systematic Assessment |
| |
| Alcohol poisoning | Injury, poisoning and procedural complications | MedDRA 20.1 | Systematic Assessment |
| |
| Cardiac function disturbance postoperative | Injury, poisoning and procedural complications | MedDRA 20.1 | Systematic Assessment |
| |
| Arterial injury | Injury, poisoning and procedural complications | MedDRA 20.1 | Systematic Assessment |
| |
| Facial bones fracture | Injury, poisoning and procedural complications | MedDRA 20.1 | Systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA 20.1 | Systematic Assessment |
| |
| Femur fracture | Injury, poisoning and procedural complications | MedDRA 20.1 | Systematic Assessment |
| |
| Foreign body | Injury, poisoning and procedural complications | MedDRA 20.1 | Systematic Assessment |
| |
| Head injury | Injury, poisoning and procedural complications | MedDRA 20.1 | Systematic Assessment |
| |
| Hip fracture | Injury, poisoning and procedural complications | MedDRA 20.1 | Systematic Assessment |
| |
| Humerus fracture | Injury, poisoning and procedural complications | MedDRA 20.1 | Systematic Assessment |
| |
| Incisional hernia | Injury, poisoning and procedural complications | MedDRA 20.1 | Systematic Assessment |
| |
| Multiple injuries | Injury, poisoning and procedural complications | MedDRA 20.1 | Systematic Assessment |
| |
| Radius fracture | Injury, poisoning and procedural complications | MedDRA 20.1 | Systematic Assessment |
| |
| Post procedural haemorrhage | Injury, poisoning and procedural complications | MedDRA 20.1 | Systematic Assessment |
| |
| Road traffic accident | Injury, poisoning and procedural complications | MedDRA 20.1 | Systematic Assessment |
| |
| Scapula fracture | Injury, poisoning and procedural complications | MedDRA 20.1 | Systematic Assessment |
| |
| Subarachnoid haemorrhage | Injury, poisoning and procedural complications | MedDRA 20.1 | Systematic Assessment |
| |
| Subdural haemorrhage | Injury, poisoning and procedural complications | MedDRA 20.1 | Systematic Assessment |
| |
| Thoracic vertebral fracture | Injury, poisoning and procedural complications | MedDRA 20.1 | Systematic Assessment |
| |
| Vascular graft thrombosis | Injury, poisoning and procedural complications | MedDRA 20.1 | Systematic Assessment |
| |
| Blood pressure increased | Investigations | MedDRA 20.1 | Systematic Assessment |
| |
| Liver function test abnormal | Investigations | MedDRA 20.1 | Systematic Assessment |
| |
| Diabetes mellitus | Metabolism and nutrition disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Diabetes mellitus inadequate control | Metabolism and nutrition disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Gout | Metabolism and nutrition disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Hypercalcaemia | Metabolism and nutrition disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Hyperkalaemia | Metabolism and nutrition disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Type 2 diabetes mellitus | Metabolism and nutrition disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Arthritis | Musculoskeletal and connective tissue disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Foot deformity | Musculoskeletal and connective tissue disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Intervertebral disc compression | Musculoskeletal and connective tissue disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Intervertebral disc protrusion | Musculoskeletal and connective tissue disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Intervertebral disc degeneration | Musculoskeletal and connective tissue disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Lumbar spinal stenosis | Musculoskeletal and connective tissue disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Myositis | Musculoskeletal and connective tissue disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Adenocarcinoma of colon | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 20.1 | Systematic Assessment |
| |
| Rotator cuff syndrome | Musculoskeletal and connective tissue disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Bladder cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 20.1 | Systematic Assessment |
| |
| Basal cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 20.1 | Systematic Assessment |
| |
| Brain neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 20.1 | Systematic Assessment |
| |
| Bladder neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 20.1 | Systematic Assessment |
| |
| Gallbladder cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 20.1 | Systematic Assessment |
| |
| Lung adenocarcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 20.1 | Systematic Assessment |
| |
| Lung neoplasm malignant | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 20.1 | Systematic Assessment |
| |
| Lung squamous cell carcinoma metastatic | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 20.1 | Systematic Assessment |
| |
| Malignant melanoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 20.1 | Systematic Assessment |
| |
| Oropharyngeal cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 20.1 | Systematic Assessment |
| |
| Metastases to liver | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 20.1 | Systematic Assessment |
| |
| Pancreatic carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 20.1 | Systematic Assessment |
| |
| Prostate cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 20.1 | Systematic Assessment |
| |
| Ureteric cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 20.1 | Systematic Assessment |
| |
| Squamous cell carcinoma of skin | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 20.1 | Systematic Assessment |
| |
| Brain oedema | Nervous system disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Altered state of consciousness | Nervous system disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Carotid artery disease | Nervous system disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Carotid artery stenosis | Nervous system disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Carotid artery occlusion | Nervous system disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Cerebrovascular accident | Nervous system disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Cerebral infarction | Nervous system disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Dementia | Nervous system disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Cognitive disorder | Nervous system disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Ischaemic stroke | Nervous system disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Ischaemic cerebral infarction | Nervous system disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Neuralgia | Nervous system disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Lumbar radiculopathy | Nervous system disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Paraesthesia | Nervous system disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Presyncope | Nervous system disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Reversible ischaemic neurological deficit | Nervous system disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Ruptured cerebral aneurysm | Nervous system disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Speech disorder | Nervous system disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Transient ischaemic attack | Nervous system disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Major depression | Psychiatric disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Intensive care unit delirium | Psychiatric disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Acute kidney injury | Renal and urinary disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Haematuria | Renal and urinary disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Nephrolithiasis | Renal and urinary disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Renal colic | Renal and urinary disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Urinary bladder polyp | Renal and urinary disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Benign prostatic hyperplasia | Reproductive system and breast disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Endometrial hyperplasia | Reproductive system and breast disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Prostatitis | Reproductive system and breast disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Uterine polyp | Reproductive system and breast disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Uterine prolapse | Reproductive system and breast disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Vaginal prolapse | Reproductive system and breast disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Acute pulmonary oedema | Respiratory, thoracic and mediastinal disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Acute respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Eosinophilic pneumonia | Respiratory, thoracic and mediastinal disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Lung cyst | Respiratory, thoracic and mediastinal disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Sleep apnoea syndrome | Respiratory, thoracic and mediastinal disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Aortic aneurysm | Vascular disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Aortic stenosis | Vascular disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Blood pressure inadequately controlled | Vascular disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Haematoma | Vascular disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Deep vein thrombosis | Vascular disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Hypertensive crisis | Vascular disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Orthostatic hypotension | Vascular disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Intermittent claudication | Vascular disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Peripheral arterial occlusive disease | Vascular disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Peripheral artery aneurysm | Vascular disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Peripheral artery occlusion | Vascular disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Peripheral artery thrombosis | Vascular disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Peripheral vascular disorder | Vascular disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Peripheral ischaemia | Vascular disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Tendon rupture | Injury, poisoning and procedural complications | MedDRA 20.1 | Systematic Assessment |
| |
| Left ventricular failure | Cardiac disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Gastroenteritis viral | Infections and infestations | MedDRA 20.1 | Systematic Assessment |
| |
| Enteritis necroticans | Infections and infestations | MedDRA 20.1 | Systematic Assessment |
| |
| Infective exacerbation of chronic obstructive airways disease | Infections and infestations | 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 |
| |
| Angina pectoris | Cardiac disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA 20.1 | Systematic Assessment |
| |
| Lower respiratory tract infection | Infections and infestations | MedDRA 20.1 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Sinusitis | Infections and infestations | 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 |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA 20.1 | Systematic Assessment |
| |
| Blood creatine phosphokinase increased | Investigations | MedDRA 20.1 | Systematic Assessment |
| |
| Hypoglycaemia | Metabolism and nutrition disorders | 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 |
| |
| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal 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 |
|
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 |
| SAP_000.pdf |
| Prot | Yes | No | No | Study Protocol | May 10, 2017 | Mar 19, 2020 | Prot_001.pdf |
| ID | Term |
|---|---|
| D006937 | Hypercholesterolemia |
| D006949 | Hyperlipidemias |
| D050197 | Atherosclerosis |
| 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 |
Not provided
Not provided
Not provided
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| No |
|
| No |
|
| No |
|
| No |
|
| No |
|
| No |
|
| No |
|
| Concomitant LMT: Yes |
|
| Moderate |
|
| High |
|
| Mild Renal Impairment: 60-89 mL/min/1.73m^2 |
|
| Moderate Renal Impairment: 30-59 mL/min/1.73m^2 |
|
| Any fatal TEAE |
|
| Any TEAE leading to discontinuation of study drug |
|
|
|
|
| Bempedoic Acid |
During the double-blind treatment period, participants received bempedoic acid 180 mg tablet, once daily by mouth for 52 weeks. In addition, participants received stable background lipid-modifying therapy(ies) including a maximally tolerated statin throughout the study. |
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