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Trial record 1 of 1 for:    NCT03067441
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Assessment of the Long-Term Safety and Efficacy of Bempedoic Acid (CLEAR Harmony OLE)

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ClinicalTrials.gov Identifier: NCT03067441
Recruitment Status : Completed
First Posted : March 1, 2017
Results First Posted : December 22, 2020
Last Update Posted : March 1, 2021
Sponsor:
Information provided by (Responsible Party):
Esperion Therapeutics, Inc.

Brief Summary:
The purpose of this study is to see if bempedoic acid (ETC-1002) is safe and well-tolerated in patients with high cardiovascular risk and elevated LDL cholesterol that is not adequately controlled by their current therapy.

Condition or disease Intervention/treatment Phase
Hypercholesterolemia Atherosclerotic Cardiovascular Disease Drug: bempedoic acid Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1462 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Multicenter Open-Label Extension (OLE) Study To Assess The Long-Term Safety and Efficacy of Bempedoic Acid (ETC-1002) 180 MG
Actual Study Start Date : February 3, 2017
Actual Primary Completion Date : November 5, 2019
Actual Study Completion Date : November 5, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Open-Label bempedoic acid
bempedoic acid 180 mg tablet
Drug: bempedoic acid
bempedoic acid 180 mg tablets taken orally, once per day.
Other Name: ETC-1002




Primary Outcome Measures :
  1. Number of Participants With Treatment-Emergent Adverse Events (TEAEs) [ Time Frame: Up to Week 82 ]
    TEAEs are defined as adverse events that began or worsened in severity after the first dose of investigational medicinal product (IMP) until 30 days after the last dose in the Open-Label Extension (OLE) Study.


Secondary Outcome Measures :
  1. Percent Change From Parent Study Baseline in Low-Density Lipoprotein Cholesterol (LDL-C) at Weeks 52 and 78 [ Time Frame: Baseline; Week 52 and Week 78 ]
    Blood samples were drawn after a minimum 10-hour fast at pre-specified intervals. Percent change from Baseline was calculated as: LDL-C value at Week 52/Week 78 minus Parent Study Baseline value divided by Parent Study Baseline value multiplied by 100. Baseline was defined as the mean of the values at screening and predose Day 1/Week 0 (Visit T1) in the Parent Study.

  2. Mean Change From Parent Study Baseline in LDL-C at Weeks 52 and 78 [ Time Frame: Baseline; Week 52 and Week 78 ]
    Blood samples were drawn after a minimum 10-hour fast at pre-specified intervals. Mean change from Baseline was calculated as: Mean LDL-C value at Week 52/Week 78 minus Mean Parent Study Baseline value. Baseline was defined as the mean of the values at screening and predose Day 1/Week 0 (Visit T1) in the Parent Study.

  3. Percent Change From Parent Study Baseline in Non-High-Density Lipoprotein Cholesterol (Non-HDL-C) at Weeks 52 and 78 [ Time Frame: Baseline; Week 52 and Week 72 ]
    Blood samples were drawn after a minimum 10-hour fast at pre-specified intervals. Percent change from Baseline was calculated as: non-HDL-C value at Week 52/Week 78 minus Parent Study Baseline value divided by Parent Study Baseline value multiplied by 100. Baseline was defined as the mean of the values at screening and predose Day 1/Week 0 (Visit T1) in the Parent Study.

  4. Percent Change From Parent Study Baseline in Total Cholesterol at Weeks 52 and 78 [ Time Frame: Baseline; Week 52 and Week 78 ]
    Blood samples were drawn after a minimum 10-hour fast at pre-specified intervals. Percent change from Baseline was calculated as: Total cholesterol value at Week 52/Week 78 minus Parent Study Baseline value divided by Parent Study Baseline value multiplied by 100. Baseline was defined as the mean of the values at screening and predose Day 1/Week 0 (Visit T1) in the Parent Study.

  5. Percent Change From Parent Study Baseline in Apolipoprotein B (ApoB) at Weeks 52 and 78 [ Time Frame: Baseline; Week 52 and Week 78 ]
    Blood samples were drawn after a minimum 10-hour fast at pre-specified intervals. Percent change from Baseline was calculated as: ApoB value at Week 52/Week 78 minus Parent Study Baseline value divided by Parent Study Baseline value multiplied by 100. Baseline was defined as the mean of the values at screening and predose Day 1/Week 0 (Visit T1) in the Parent Study.

  6. Percent Change From Parent Study Baseline in High-Sensitivity C-Reactive Protein (Hs-CRP) at Weeks 52 and 78 [ Time Frame: Baseline; Week 52 and Week 78 ]
    Blood samples were drawn after a minimum 10-hour fast at pre-specified intervals. Percent change from Baseline was calculated as: hs-CRP value at Week 52/Week 78 minus Parent Study Baseline value divided by Parent Study Baseline value multiplied by 100. Baseline was defined as the mean of the values at screening and predose Day 1/Week 0 (Visit T1) in the Parent Study.

  7. Percent Change From Parent Study Baseline in Triglycerides at Weeks 52 and 78 [ Time Frame: Baseline; Week 52 and Week 78 ]
    Blood samples were drawn after a minimum 10-hour fast at pre-specified intervals. Percent change from Baseline was calculated as: Triglycerides value at Week 52/Week 78 minus Parent Study Baseline value divided by Parent Study Baseline value multiplied by 100. Baseline was defined as the mean of the values at screening and predose Day 1/Week 0 (Visit T1) in the Parent Study.

  8. Percent Change From Parent Study Baseline in High-Density Lipoprotein Cholesterol (HDL-C) at Weeks 52 and 78 [ Time Frame: Baseline; Week 52 and Week 78 ]
    Blood samples were drawn after a minimum 10-hour fast at pre-specified intervals. Percent change from Baseline was calculated as: HDL-C value at Week 52/Week 78 minus Parent Study Baseline value divided by Parent Study Baseline value multiplied by 100. Baseline was defined as the mean of the values at screening and predose Day 1/Week 0 (Visit T1) in the Parent Study.

  9. Percent Change From Open-Label Extension (OLE) Study Baseline in LDL-C at Weeks 52 and 78 [ Time Frame: Baseline; Week 52 and Week 78 ]
    Blood samples were drawn after a minimum 10-hour fast at pre-specified intervals. Percent change from Baseline was calculated as: LDL-C value at Week 52/Week 78 minus OLE Study Baseline value divided by Parent Study Baseline value multiplied by 100. Baseline was defined as the last non-missing record prior to treatment start in the OLE Study.

  10. Mean Change From OLE Baseline in LDL-C at Weeks 52 and 78 [ Time Frame: Baseline; Week 52 and Week 72 ]
    Blood samples were drawn after a minimum 10-hour fast at pre-specified intervals. Mean change from Baseline was calculated as: Mean LDL-C value at Week 52/Week 78 minus Mean OLE Study Baseline value. Baseline was defined as the last non-missing record prior to treatment start in the OLE Study.

  11. Percent Change From OLE Baseline in Non-HDL-C at Weeks 52 and 78 [ Time Frame: Baseline; Week 52 and Week 78 ]
    Blood samples were drawn after a minimum 10-hour fast at pre-specified intervals. Percent change from Baseline was calculated as: non-HDL-C value at Week 52/Week 78 minus OLE Study Baseline value divided by OLE Study Baseline value multiplied by 100. Baseline was defined as the last non-missing record prior to treatment start in the OLE Study.

  12. Percent Change From OLE Baseline in Total Cholesterol at Weeks 52 and 78 [ Time Frame: Baseline; Week 52 and Week 78 ]
    Blood samples were drawn after a minimum 10-hour fast at pre-specified intervals. Percent change from Baseline was calculated as: Total Cholesterol value at Week 52/Week 78 minus OLE Study Baseline value divided by OLE Study Baseline value multiplied by 100. Baseline was defined as the last non-missing record prior to treatment start in the OLE Study.

  13. Percent Change From OLE Baseline ApoB at Weeks 52 and 78 [ Time Frame: Baseline; Week 52 and Week 78 ]
    Blood samples were drawn after a minimum 10-hour fast at pre-specified intervals. Percent change from Baseline was calculated as: ApoB value at Week 52/Week 78 minus OLE Study Baseline value divided by OLE Study Baseline value multiplied by 100. Baseline was defined as the last non-missing record prior to treatment start in the OLE Study.

  14. Percent Change From OLE Baseline in Hs-CRP at Weeks 52 and 78 [ Time Frame: Baseline; Week 52 and Week 78 ]
    Blood samples were drawn after a minimum 10-hour fast at pre-specified intervals. Percent change from Baseline was calculated as: hs-CRP value at Week 52/Week 78 minus OLE Study Baseline value divided by OLE Study Baseline value multiplied by 100. Baseline was defined as the last non-missing record prior to treatment start in the OLE Study.

  15. Percent Change From OLE Baseline in Triglycerides at Weeks 52 and 78 [ Time Frame: Baseline; Week 52 and Week 78 ]
    Blood samples were drawn after a minimum 10-hour fast at pre-specified intervals. Percent change from Baseline was calculated as: Triglycerides value at Week 52/Week 78 minus OLE Study Baseline value divided by OLE Study Baseline value multiplied by 100. Baseline was defined as the last non-missing record prior to treatment start in the OLE Study.

  16. Percent Change From OLE Baseline in HDL-C at Weeks 52 and 78 [ Time Frame: Baseline; Week 52 and Week 78 ]
    Blood samples were drawn after a minimum 10-hour fast at pre-specified intervals. Percent change from Baseline was calculated as: HDL-C value at Week 52/Week 78 minus OLE Study Baseline value divided by OLE Study Baseline value multiplied by 100. Baseline was defined as the last non-missing record prior to treatment start in the OLE Study.



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:

  • Successfully completed CLEAR Harmony (1002-040) parent study

Exclusion Criteria:

  • Experienced a treatment-related SAE that led to study drug discontinuation in the CLEAR Harmony (1002-040) parent study.
  • Medical condition requires lipid measurement and/or adjustment of background lipid-regulating therapy.

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): NCT03067441


Locations
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United States, Florida
Jedidiah Clinical Research
Tampa, Florida, United States, 33607
United States, Kentucky
L-MARC Research Center
Louisville, Kentucky, United States, 40213
United States, Ohio
Sentral Clinical Research Services
Cincinnati, Ohio, United States, 45236
Sponsors and Collaborators
Esperion Therapeutics, Inc.
Investigators
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Study Director: Medical Director Esperion Therapeutics, Inc.
  Study Documents (Full-Text)

Documents provided by Esperion Therapeutics, Inc.:
Study Protocol  [PDF] January 15, 2018
Statistical Analysis Plan  [PDF] December 5, 2019

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

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Responsible Party: Esperion Therapeutics, Inc.
ClinicalTrials.gov Identifier: NCT03067441    
Other Study ID Numbers: 1002-050
2016-004115-12 ( EudraCT Number )
First Posted: March 1, 2017    Key Record Dates
Results First Posted: December 22, 2020
Last Update Posted: March 1, 2021
Last Verified: February 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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, Inc.:
hyperlipidemia
cholesterol
heterozygous familial hypercholesterolemia
atherosclerotic cardiovascular disease
ASCVD
HeFH
LDL
Additional relevant MeSH terms:
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Cardiovascular Diseases
Atherosclerosis
Hypercholesterolemia
Hyperlipidemias
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
8-hydroxy-2,2,14,14-tetramethylpentadecanedioic acid
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Enzyme Inhibitors
Hypoglycemic Agents
Physiological Effects of Drugs