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
NCT ID: NCT03051100
Last Updated: 2020-04-03
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
63 participants
INTERVENTIONAL
2017-01-19
2017-07-05
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Triplet Therapy
Bempedoic acid 180 mg, ezetimibe 10 mg, and atorvastatin 20 mg taken orally, daily.
Bempedoic acid 180mg
bempedoic acid 180 mg
Ezetimibe 10mg
ezetimibe 10 mg
Atorvastatin 20mg
atorvastatin 20 mg
placebo
Matching placebos taken orally, daily.
Placebo
placebo
Interventions
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Bempedoic acid 180mg
bempedoic acid 180 mg
Ezetimibe 10mg
ezetimibe 10 mg
Atorvastatin 20mg
atorvastatin 20 mg
Placebo
placebo
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Men and nonpregnant, nonlactating women
* Sufficiently stable and suitable to undergo washout of all LDL-C-lowering drugs and nutritional supplements for 12 weeks
Exclusion Criteria
* Body Mass Index (BMI) greater than 50 kg/m2
* History of clinically significant cardiovascular disease
* History of type 1 or type 2 diabetes
18 Years
ALL
No
Sponsors
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Esperion Therapeutics, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Ron Haberman, MD
Role: STUDY_DIRECTOR
Esperion Therapeutics, Inc.
Locations
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PMG Research of Christie Clinic
Champaign, Illinois, United States
PMG Research of Cary
Cary, North Carolina, United States
PMG Research of Charlotte
Charlotte, North Carolina, United States
Sensenbrenner Primary Care
Charlotte, North Carolina, United States
PMG Research of Hickory
Hickory, North Carolina, United States
PMG Research of Raleigh
Raleigh, North Carolina, United States
PMG Research of Rocky Mount
Rocky Mount, North Carolina, United States
PMG Research Salisbury
Salisbury, North Carolina, United States
PMG Research of Wilmington
Wilmington, North Carolina, United States
PMG Research of Charleston
Mt. Pleasant, South Carolina, United States
Hampton Roads Center for Clinical Research
Virginia Beach, Virginia, United States
Countries
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References
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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.
Bilen O, Ballantyne CM. Bempedoic Acid (ETC-1002): an Investigational Inhibitor of ATP Citrate Lyase. Curr Atheroscler Rep. 2016 Oct;18(10):61. doi: 10.1007/s11883-016-0611-4.
Thompson PD, MacDougall DE, Newton RS, Margulies JR, Hanselman JC, Orloff DG, McKenney JM, Ballantyne CM. Treatment with ETC-1002 alone and in combination with ezetimibe lowers LDL cholesterol in hypercholesterolemic patients with or without statin intolerance. J Clin Lipidol. 2016 May-Jun;10(3):556-67. doi: 10.1016/j.jacl.2015.12.025. Epub 2016 Jan 6.
Ballantyne CM, McKenney JM, MacDougall DE, Margulies JR, Robinson PL, Hanselman JC, Lalwani ND. Effect of ETC-1002 on Serum Low-Density Lipoprotein Cholesterol in Hypercholesterolemic Patients Receiving Statin Therapy. Am J Cardiol. 2016 Jun 15;117(12):1928-33. doi: 10.1016/j.amjcard.2016.03.043. Epub 2016 Apr 6.
Thompson PD, Rubino J, Janik MJ, MacDougall DE, McBride SJ, Margulies JR, Newton RS. Use of ETC-1002 to treat hypercholesterolemia in patients with statin intolerance. J Clin Lipidol. 2015 May-Jun;9(3):295-304. doi: 10.1016/j.jacl.2015.03.003. Epub 2015 Mar 19.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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1002-038
Identifier Type: -
Identifier Source: org_study_id
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