Evaluation of ETC-1002 in Participants With Hypercholesterolemia and Hypertension
NCT ID: NCT02178098
Last Updated: 2023-04-04
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
143 participants
INTERVENTIONAL
2014-06-16
2015-05-22
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
ETC-1002 180 mg/day
ETC-1002
ETC-1002 capsules taken once daily
Placebo
Placebo control
Placebo
Placebo capsules taken once daily
Interventions
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ETC-1002
ETC-1002 capsules taken once daily
Placebo
Placebo capsules taken once daily
Eligibility Criteria
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Inclusion Criteria
* or- Mean 24-hour ambulatory DBP greater than or equal to 80 mmHg
* Fasting LDL-C between 100 and 220 mg/dL
* Fasting triglycerides less than 400 mg/dL
* Body mass index (BMI) between 18 and 45 kg/m2
Exclusion Criteria
* Taking more than two anti-hypertension medications at the first visit
* History or current clinically significant cardiovascular disease
* History or current type 1 diabetes or type 2 diabetes
18 Years
80 Years
ALL
No
Sponsors
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Medpace, Inc.
INDUSTRY
Esperion Therapeutics, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Medpace Medical Monitor
Role: STUDY_DIRECTOR
Medpace, Inc.
Locations
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Birmingham, Alabama, United States
Muscle Shoals, Alabama, United States
Chandler, Arizona, United States
Glendale, Arizona, United States
Los Angeles, California, United States
DeLand, Florida, United States
Fort Lauderdale, Florida, United States
Hialeah, Florida, United States
Oviedo, Florida, United States
Pembroke Pines, Florida, United States
Pembroke Pines, Florida, United States
Port Orange, Florida, United States
Meridian, Idaho, United States
Chicago, Illinois, United States
Gurnee, Illinois, United States
Indianapolis, Indiana, United States
Paducah, Kentucky, United States
Auburn, Maine, United States
Olive Branch, Mississippi, United States
Butte, Montana, United States
Las Vegas, Nevada, United States
Berlin, New Jersey, United States
Endwell, New York, United States
Wilmington, North Carolina, United States
Cincinnati, Ohio, United States
Cincinnati, Ohio, United States
Cincinnati, Ohio, United States
Lyndhurst, Ohio, United States
Willoughby Hills, Ohio, United States
Tulsa, Oklahoma, United States
Eugene, Oregon, United States
Downingtown, Pennsylvania, United States
Site 1
Mt. Pleasant, South Carolina, United States
Site 2
Mt. Pleasant, South Carolina, United States
Simpsonville, South Carolina, United States
Corpus Christi, Texas, United States
Dallas, Texas, United States
Dallas, Texas, United States
Houston, Texas, United States
Salt Lake City, Utah, United States
Salt Lake City, Utah, United States
Kenosha, Wisconsin, United States
Madison, Wisconsin, United States
Countries
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References
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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.
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.
Pinkosky SL, Filippov S, Srivastava RA, Hanselman JC, Bradshaw CD, Hurley TR, Cramer CT, Spahr MA, Brant AF, Houghton JL, Baker C, Naples M, Adeli K, Newton RS. AMP-activated protein kinase and ATP-citrate lyase are two distinct molecular targets for ETC-1002, a novel small molecule regulator of lipid and carbohydrate metabolism. J Lipid Res. 2013 Jan;54(1):134-51. doi: 10.1194/jlr.M030528. Epub 2012 Nov 1.
Filippov S, Pinkosky SL, Lister RJ, Pawloski C, Hanselman JC, Cramer CT, Srivastava RAK, Hurley TR, Bradshaw CD, Spahr MA, Newton RS. ETC-1002 regulates immune response, leukocyte homing, and adipose tissue inflammation via LKB1-dependent activation of macrophage AMPK. J Lipid Res. 2013 Aug;54(8):2095-2108. doi: 10.1194/jlr.M035212. Epub 2013 May 24.
Other Identifiers
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1002-014
Identifier Type: -
Identifier Source: org_study_id
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