Evaluation of Long-Term Safety and Tolerability of ETC-1002 in High-Risk Patients With Hyperlipidemia and High CV Risk (CLEAR Harmony)
NCT ID: NCT02666664
Last Updated: 2020-05-11
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE3
2230 participants
INTERVENTIONAL
2016-01-21
2018-03-28
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Evaluation of the Efficacy and Safety of Bempedoic Acid (ETC-1002) as Add-on to Ezetimibe Therapy in Patients With Elevated LDL-C (CLEAR Tranquility)
NCT03001076
Evaluation of ETC-1002 in Participants With Hypercholesterolemia and Hypertension
NCT02178098
A Study of the Safety, Pharmacokinetic Drug Interaction and Efficacy of ETC-1002 and Atorvastatin in Subjects With Hypercholesterolemia
NCT01779453
Evaluation of ETC-1002, Ezetimibe, and the Combination in Hypercholesterolemic Patients
NCT01941836
Evaluation of the Efficacy and Safety of Bempedoic Acid (ETC-1002) in Patients With Hyperlipidemia and Statin Intolerant
NCT02988115
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
ETC-1002
ETC-1002 180 mg/day
ETC-1002
ETC-1002 180 mg tablets taken orally, once per day. Patients remain on ongoing statin therapy (not study provided)
Placebo
Placebo control
Placebo
Matching placebo tablets taken orally, once per day. Patients remain on ongoing statin therapy (not study provided)
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
ETC-1002
ETC-1002 180 mg tablets taken orally, once per day. Patients remain on ongoing statin therapy (not study provided)
Placebo
Matching placebo tablets taken orally, once per day. Patients remain on ongoing statin therapy (not study provided)
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* High cardiovascular risk (diagnosis of HeFH or ASCVD)
* Be on maximally tolerated lipid-modifying therapy
Exclusion Criteria
* Renal dysfunction or nephrotic syndrome or history of nephritis
* Body Mass Index (BMI) ≥50kg/m2
* Significant cardiovascular disease or cardiovascular event in the past 3 months
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Esperion Therapeutics, Inc.
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Ron Haberman, MD
Role: STUDY_DIRECTOR
Esperion Therapeutics, Inc.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Huntsville, Alabama, United States
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
Miami Lakes, Florida, United States
Tampa, Florida, United States
Park Ridge, Illinois, United States
Iowa City, Iowa, United States
Overland Park, Kansas, United States
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
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Provided Documents
Download supplemental materials such as informed consent forms, study protocols, or participant manuals.
Document Type: Statistical Analysis Plan
Document Type: Study Protocol
Related Links
Access external resources that provide additional context or updates about the study.
World Health Organization Fact Sheet No. 317
Familial Hypercholesterolemia Foundation
National Organization for Rare Disorders - Familial Hypercholesterolemia
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
2015-004136-36
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
1002-040
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.