A Study Of Pharmacokinetics, Pharmacodynamics And Safety Of Adding ETC-1002 To Atorvastatin 80 mg
NCT ID: NCT02659397
Last Updated: 2019-03-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
68 participants
INTERVENTIONAL
2015-12-31
2016-07-31
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
QUADRUPLE
Study Groups
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ETC-1002 + Atorvastatin
ETC-1002 180 mg treatment, oral once daily added-on to Atorvastatin 80 mg once daily
ETC-1002
Blinded ETC-1002 180 mg tablet once daily for 4 weeks (Weeks 1 to 4)
Atorvastatin
Atorvastatin 80 mg tablet once daily for 8 weeks (Weeks -4 to 4)
Placebo + Atorvastatin
Placebo treatment, oral once daily added-on to Atorvastatin 80 mg once daily
Atorvastatin
Atorvastatin 80 mg tablet once daily for 8 weeks (Weeks -4 to 4)
Placebo
Blinded ETC-1002-matched placebo tablet once daily for 4 weeks (Weeks 1 to 4)
Interventions
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ETC-1002
Blinded ETC-1002 180 mg tablet once daily for 4 weeks (Weeks 1 to 4)
Atorvastatin
Atorvastatin 80 mg tablet once daily for 8 weeks (Weeks -4 to 4)
Placebo
Blinded ETC-1002-matched placebo tablet once daily for 4 weeks (Weeks 1 to 4)
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* LDL-C between 100-220 mg/dL for patients taking daily high-intensity statin (for 4 weeks prior to switching to sponsor -provided atorvastatin 80 mg/day and stopping all other lipid-regulating drugs and supplements) at the screening visit; or,
* LDL-C between 115-220 mg/dL for patients taking moderate- or low-intensity statin (for 4 weeks prior to switching to sponsor -provided atorvastatin 80 mg/day and stopping all other lipid-regulating drugs and supplements) at the screening visit.
* Must be willing to discontinue other lipid-regulating therapies during the study
Exclusion Criteria
* Current clinically significant cardiovascular disease.
* History of inability to tolerate any statin at any dose due to muscle-related pain or weakness.
18 Years
70 Years
ALL
No
Sponsors
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Esperion Therapeutics, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Mary McGowan, MD
Role: STUDY_DIRECTOR
Esperion Therapeutics, Inc.
Locations
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Anaheim, California, United States
Los Angeles, California, United States
Northridge, California, United States
Clearwater, Florida, United States
Jacksonville, Florida, United States
Miami, Florida, United States
Port Orange, Florida, United States
Boise, Idaho, United States
Chicago, Illinois, United States
Springfield, Illinois, United States
Louisville, Kentucky, United States
Berlin, New Jersey, United States
Rapid City, South Dakota, United States
Carrollton, Texas, United States
West Jordan, Utah, United States
Arlington, Virginia, United States
Lynchburg, Virginia, United States
Richmond, Virginia, United States
Renton, Washington, United States
Countries
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References
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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.
Nikolic D, Mikhailidis DP, Davidson MH, Rizzo M, Banach M. ETC-1002: a future option for lipid disorders? Atherosclerosis. 2014 Dec;237(2):705-10. doi: 10.1016/j.atherosclerosis.2014.10.099. Epub 2014 Oct 31.
Filippov S, Pinkosky SL, Newton RS. LDL-cholesterol reduction in patients with hypercholesterolemia by modulation of adenosine triphosphate-citrate lyase and adenosine monophosphate-activated protein kinase. Curr Opin Lipidol. 2014 Aug;25(4):309-15. doi: 10.1097/MOL.0000000000000091.
Gutierrez MJ, Rosenberg NL, Macdougall DE, Hanselman JC, Margulies JR, Strange P, Milad MA, McBride SJ, Newton RS. Efficacy and safety of ETC-1002, a novel investigational low-density lipoprotein-cholesterol-lowering therapy for the treatment of patients with hypercholesterolemia and type 2 diabetes mellitus. Arterioscler Thromb Vasc Biol. 2014 Mar;34(3):676-83. doi: 10.1161/ATVBAHA.113.302677. Epub 2014 Jan 2.
Ballantyne CM, Davidson MH, Macdougall DE, Bays HE, Dicarlo LA, Rosenberg NL, Margulies J, Newton RS. Efficacy and safety of a novel dual modulator of adenosine triphosphate-citrate lyase and adenosine monophosphate-activated protein kinase in patients with hypercholesterolemia: results of a multicenter, randomized, double-blind, placebo-controlled, parallel-group trial. J Am Coll Cardiol. 2013 Sep 24;62(13):1154-62. doi: 10.1016/j.jacc.2013.05.050. Epub 2013 Jun 13.
Other Identifiers
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1002-035
Identifier Type: -
Identifier Source: org_study_id
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