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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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03337308
Recruitment Status : Completed
First Posted : November 8, 2017
Last Update Posted : September 25, 2018
Sponsor:
Information provided by (Responsible Party):
Esperion Therapeutics

Brief Summary:
The purpose of this study is to determine if Bempedoic Acid (BA) + Ezetimibe (EZE) in a fixed-dose combination (FDC) is effective and safe versus its individual components and placebo in patients with elevated LDL cholesterol treated with maximally tolerated statin therapy.

Condition or disease Intervention/treatment Phase
Hyperlipidemias Combination Product: Bempedoic Acid + Ezetimibe Fixed-Dose Combination Drug: Bempedoic Acid Drug: Ezetimibe Drug: Placebos Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 382 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized, Double-Blind, Parallel Group Study to Evaluate the Efficacy and Safety of Bempedoic Acid 180 Mg + Ezetimibe 10 Mg Fixed-Dose Combination Compared to Bempedoic Acid, Ezetimibe, and Placebo Alone in Patients Treated With Maximally Tolerated Statin Therapy
Actual Study Start Date : October 23, 2017
Actual Primary Completion Date : June 18, 2018
Actual Study Completion Date : July 18, 2018

Resource links provided by the National Library of Medicine

Drug Information available for: Ezetimibe

Arm Intervention/treatment
Experimental: BA 180 mg + EZE 10 mg FDC
Bempedoic acid (BA) + ezetimibe (EZE) fixed-dose combination (FDC) 180 mg/10 mg tablets taken orally once daily for 12 weeks
Combination Product: Bempedoic Acid + Ezetimibe Fixed-Dose Combination
bempedoic acid + ezetimibe FDC 180 mg/10 mg tablet
Other Names:
  • Bempedoic Acid + Zetia FDC
  • ETC-1002 + Zetia

Drug: Placebos
placebo tablet or capsule to match bempedoic acid + ezetimibe fixed-dose combination (FDC) 180 mg/10 mg tablet, or bempedoic acid 180 mg tablet, or ezetimibe 10 mg capsule
Other Name: Placebo

Experimental: BA 180 mg
Bempedoic acid (BA) 180 mg tablets taken orally once daily for 12 weeks
Drug: Bempedoic Acid
bempedoic acid 180 mg tablet
Other Name: ETC-1002

Drug: Placebos
placebo tablet or capsule to match bempedoic acid + ezetimibe fixed-dose combination (FDC) 180 mg/10 mg tablet, or bempedoic acid 180 mg tablet, or ezetimibe 10 mg capsule
Other Name: Placebo

Active Comparator: EZE 10 mg
Ezetimibe (EZE) 10 mg overencapsulated tablets taken orally once daily for 12 weeks
Drug: Ezetimibe
ezetimibe 10 mg overencapsulated tablet
Other Name: Zetia

Drug: Placebos
placebo tablet or capsule to match bempedoic acid + ezetimibe fixed-dose combination (FDC) 180 mg/10 mg tablet, or bempedoic acid 180 mg tablet, or ezetimibe 10 mg capsule
Other Name: Placebo

Placebo Comparator: Placebos
Placebos to match identical bempedoic acid + ezetimibe fixed-dose combination (FDC) 180 mg/10 mg tablet, or identical bempedoic acid 180 mg tablet, or identical ezetimibe 10 mg capsule, taken orally, once daily for 12 weeks
Drug: Placebos
placebo tablet or capsule to match bempedoic acid + ezetimibe fixed-dose combination (FDC) 180 mg/10 mg tablet, or bempedoic acid 180 mg tablet, or ezetimibe 10 mg capsule
Other Name: Placebo




Primary Outcome Measures :
  1. Percent change in low-density lipoprotein cholesterol (LDL-C) [ Time Frame: Baseline through 12 weeks ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Require lipid-modifying therapy for primary or secondary prevention of cardiovascular disease
  • Fasting LDL-C ≥ 130 mg/dL for primary prevention or LDL-C ≥ 100 mg/dL for secondary prevention (history of HeFH and/or ASCVD)
  • Treated with maximally tolerated statin therapy at stable dose for at least 4 weeks prior to screening

Exclusion Criteria:

  • Total Fasting Triglyceride ≥ 400 mg/dL
  • Renal Dysfunction or nephrotic syndrome or history of nephritis
  • Significant cardiovascular disease or cardiovascular event within the past 3 months

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03337308


Locations
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United States, Iowa
PMG Research of McFarland
Ames, Iowa, United States, 50010
United States, New Hampshire
Foundation Cardiology
Nashua, New Hampshire, United States, 03060
United States, North Carolina
PMG Research of Piedmont Healthcare
Statesville, North Carolina, United States, 28625
PMG Research of Wilmington
Wilmington, North Carolina, United States, 28401
United States, Tennessee
PMG Research of Knoxville
Knoxville, Tennessee, United States, 37912
Sponsors and Collaborators
Esperion Therapeutics
Investigators
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Study Director: James Cappola, MD Esperion Therapeutics

Publications:
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. Erratum in: Circulation. 2015 Dec 22;132(25):e396. Circulation. 2014 Jun 24;129(25 Suppl 2):S46-8.

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Responsible Party: Esperion Therapeutics
ClinicalTrials.gov Identifier: NCT03337308     History of Changes
Other Study ID Numbers: 1002FDC-053
First Posted: November 8, 2017    Key Record Dates
Last Update Posted: September 25, 2018
Last Verified: September 2018

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Esperion Therapeutics:
hyperlipidemia
heterozygous familial hypercholesterolemia
atherosclerotic cardiovascular disease
high cholesterol
ASCVD
HeFH
LDL

Additional relevant MeSH terms:
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Hyperlipidemias
Hyperlipoproteinemias
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases
Ezetimibe
8-hydroxy-2,2,14,14-tetramethylpentadecanedioic acid
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Enzyme Inhibitors
Hypoglycemic Agents
Physiological Effects of Drugs