Evaluation of the Efficacy and Safety of Bempedoic Acid (ETC-1002) in Patients With Hyperlipidemia and Statin Intolerant
NCT ID: NCT02988115
Last Updated: 2020-04-03
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
345 participants
INTERVENTIONAL
2016-11-16
2018-03-16
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 the Efficacy and Safety of Bempedoic Acid (ETC-1002) 180mg, Ezetimibe 10mg, and Atorvastatin 20 mg Triplet Therapy in Patients With Elevated LDL-C
NCT03051100
A Study Evaluating the Safety and Efficacy of Bempedoic Acid Plus Ezetimibe Fixed-Dose Combination Compared to Bempedoic Acid, Ezetimibe, and Placebo in Patients Treated With Maximally Tolerated Statin Therapy
NCT03337308
Evaluation of ETC-1002 vs Placebo in Patients Receiving Ongoing Statin Therapy
NCT02072161
A Study of the Efficacy and Safety of ETC-1002 in Participants With Statin Intolerance
NCT01751984
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.
bempedoic acid
bempedoic acid 180 mg tablet taken orally, daily. Patients remain on ongoing lipid-modifying therapy (not study provided)
bempedoic acid
bempedoic acid 180 mg tablet
placebo
Matching placebo tablet taken orally, daily. Patients remain on ongoing lipid-modifying therapy (not study provided)
placebo
Matching placebo tablet
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
bempedoic acid
bempedoic acid 180 mg tablet
placebo
Matching placebo tablet
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
* Fasting LDL-C ≥130 mg/dL for primary prevention or LDL-C ≥100 mg/dL for secondary prevention (history of HeFH and/or ASCVD)
* Be statin-intolerant (unable to tolerate 2 or more statins)
Exclusion Criteria
* Renal dysfunction or nephrotic syndrome or history of nephritis
* Body Mass Index (BMI) ≥50 kg/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.
Gilbert, Arizona, United States
Anaheim, California, United States
Long Beach, California, United States
Sacramento, California, United States
Santa Ana, California, United States
Torrance, California, United States
Ventura, California, United States
Hamden, Connecticut, United States
Daytona Beach, Florida, United States
Fort Lauderdale, Florida, United States
Site 1
Miami, Florida, United States
Site 2
Miami, Florida, United States
Orlando, Florida, United States
West Palm Beach, Florida, United States
Atlanta, Georgia, United States
Savannah, Georgia, United States
Meridian, Idaho, United States
Evanston, Illinois, United States
Evansville, Indiana, United States
Iowa City, Iowa, United States
Waterloo, Iowa, United States
Monroe, Louisiana, United States
Slidell, Louisiana, United States
Tupelo, Mississippi, United States
Lincoln, Nebraska, United States
Somerset, New Jersey, United States
Binghamton, New York, United States
Endwell, New York, United States
New Windsor, New York, United States
Greensboro, North Carolina, United States
Morganton, North Carolina, United States
Mount Airy, North Carolina, United States
Columbus, Ohio, United States
Marion, Ohio, United States
Maumee, Ohio, United States
Oklahoma City, Oklahoma, United States
Beaver, Pennsylvania, United States
Langhorne, Pennsylvania, United States
Cumberland, Rhode Island, United States
Anderson, South Carolina, United States
Summerville, South Carolina, United States
Jackson, Tennessee, United States
Knoxville, Tennessee, United States
Memphis, Tennessee, United States
Amarillo, Texas, United States
Site 1
Dallas, Texas, United States
Site 2
Dallas, Texas, United States
Houston, Texas, United States
San Antonio, Texas, United States
Clinton, Utah, United States
Hampton, Virginia, United States
Kenosha, Wisconsin, United States
Brossard, , Canada
Chicoutimi, , Canada
Gatineau, , Canada
London, , Canada
Longueuil, , Canada
Mirabel, , Canada
Montreal, , Canada
Newmarket, , Canada
Oakville, , Canada
Peterborough, , Canada
Pointe-Claire, , Canada
Saint-Jérôme, , Canada
Sarnia, , Canada
Toronto, , Canada
Victoriaville, , Canada
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.
Cholesterol Treatment Trialists' (CTT) Collaboration; Baigent C, Blackwell L, Emberson J, Holland LE, Reith C, Bhala N, Peto R, Barnes EH, Keech A, Simes J, Collins R. Efficacy and safety of more intensive lowering of LDL cholesterol: a meta-analysis of data from 170,000 participants in 26 randomised trials. Lancet. 2010 Nov 13;376(9753):1670-81. doi: 10.1016/S0140-6736(10)61350-5. Epub 2010 Nov 8.
Eckel RH. Approach to the patient who is intolerant of statin therapy. J Clin Endocrinol Metab. 2010 May;95(5):2015-22. doi: 10.1210/jc.2009-2689.
Ridker PM, Cannon CP, Morrow D, Rifai N, Rose LM, McCabe CH, Pfeffer MA, Braunwald E; Pravastatin or Atorvastatin Evaluation and Infection Therapy-Thrombolysis in Myocardial Infarction 22 (PROVE IT-TIMI 22) Investigators. C-reactive protein levels and outcomes after statin therapy. N Engl J Med. 2005 Jan 6;352(1):20-8. doi: 10.1056/NEJMoa042378.
Robinson JG, Stone NJ. The 2013 ACC/AHA guideline on the treatment of blood cholesterol to reduce atherosclerotic cardiovascular disease risk: a new paradigm supported by more evidence. Eur Heart J. 2015 Aug 14;36(31):2110-2118. doi: 10.1093/eurheartj/ehv182. Epub 2015 May 20.
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.
Laufs U, Banach M, Mancini GBJ, Gaudet D, Bloedon LT, Sterling LR, Kelly S, Stroes ESG. Efficacy and Safety of Bempedoic Acid in Patients With Hypercholesterolemia and Statin Intolerance. J Am Heart Assoc. 2019 Apr 2;8(7):e011662. doi: 10.1161/JAHA.118.011662.
Provided Documents
Download supplemental materials such as informed consent forms, study protocols, or participant manuals.
Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Related Links
Access external resources that provide additional context or updates about the study.
World Health Organization Fact Sheet No. 317
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
1002-046
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.