A Study to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamic Effects of MEDI5884 in Adults With Stable Coronary Heart Disease
NCT ID: NCT03351738
Last Updated: 2020-03-23
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
133 participants
INTERVENTIONAL
2017-12-13
2018-11-09
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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Placebo
Participants will receive subcutaneous (SC) dose of placebo (volume matched to MEDI5884) on Days 1, 31, and 61.
Placebo
Participants will receive SC dose of placebo (volume matched to MEDI5884) on Days 1, 31, and 61.
MEDI5884 50 mg
Participants will receive SC dose of MEDI5884 50 mg on Days 1, 31, and 61.
MEDI5884
Participants will receive SC dose of MEDI5884 50 mg or 100 mg or 200 mg or 350 mg or 500 mg on Days 1, 31, and 61.
MEDI5884 100 mg
Participants will receive SC dose of MEDI5884 100 mg on Days 1, 31, and 61.
MEDI5884
Participants will receive SC dose of MEDI5884 50 mg or 100 mg or 200 mg or 350 mg or 500 mg on Days 1, 31, and 61.
MEDI5884 200 mg
Participants will receive SC dose of MEDI5884 200 mg on Days 1, 31, and 61.
MEDI5884
Participants will receive SC dose of MEDI5884 50 mg or 100 mg or 200 mg or 350 mg or 500 mg on Days 1, 31, and 61.
MEDI5884 350 mg
Participants will receive SC dose of MEDI5884 350 mg on Days 1, 31, and 61.
MEDI5884
Participants will receive SC dose of MEDI5884 50 mg or 100 mg or 200 mg or 350 mg or 500 mg on Days 1, 31, and 61.
MEDI5884 500 mg
Participants will receive SC dose of MEDI5884 500 mg on Days 1, 31, and 61.
MEDI5884
Participants will receive SC dose of MEDI5884 50 mg or 100 mg or 200 mg or 350 mg or 500 mg on Days 1, 31, and 61.
Interventions
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MEDI5884
Participants will receive SC dose of MEDI5884 50 mg or 100 mg or 200 mg or 350 mg or 500 mg on Days 1, 31, and 61.
Placebo
Participants will receive SC dose of placebo (volume matched to MEDI5884) on Days 1, 31, and 61.
Eligibility Criteria
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Inclusion Criteria
* Currently receiving high intensity statin(s)
Exclusion Criteria
* Any planned arterial revascularizations
* Fasting Laboratory values at screening: Triglycerides \> 500 mg/dl, Low Density Lipoprotein-Cholesterol \> 100 mg/dL
* Any disease or condition or laboratory value that would place the participant at an unacceptable risk.
45 Years
80 Years
ALL
No
Sponsors
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MedImmune LLC
INDUSTRY
Responsible Party
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Principal Investigators
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Michael J Koren, MD, FACC
Role: PRINCIPAL_INVESTIGATOR
Jacksonville Center For Clinical Research
Locations
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Research Site
Anniston, Alabama, United States
Research Site
Huntsville, Alabama, United States
Research Site
El Cajon, California, United States
Research Site
Lincoln, California, United States
Research Site
Northridge, California, United States
Research Site
Waterbury, Connecticut, United States
Research Site
Fleming Island, Florida, United States
Research Site
Jacksonville, Florida, United States
Research Site
Pembroke Pines, Florida, United States
Research Site
Port Orange, Florida, United States
Research Site
Savannah, Georgia, United States
Research Site
Evanston, Illinois, United States
Research Site
Indianapolis, Indiana, United States
Research Site
Louisville, Kentucky, United States
Research Site
Fargo, North Dakota, United States
Research Site
Cincinnati, Ohio, United States
Research Site
Marion, Ohio, United States
Research Site
Stow, Ohio, United States
Research Site
Oklahoma City, Oklahoma, United States
Research Site
Rapid City, South Dakota, United States
Research Site
Kingsport, Tennessee, United States
Research Site
McAllen, Texas, United States
Research Site
San Antonio, Texas, United States
Countries
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References
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Ruff CT, Koren MJ, Grimsby J, Rosenbaum AI, Tu X, Karathanasis SK, Falloon J, Hsia J, Guan Y, Conway J, Tsai LF, Hummer BT, Hirshberg B, Kuder JF, Murphy SA, George RT, Sabatine MS. LEGACY: Phase 2a Trial to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamic Effects of the Anti-EL (Endothelial Lipase) Antibody MEDI5884 in Patients With Stable Coronary Artery Disease. Arterioscler Thromb Vasc Biol. 2021 Dec;41(12):3005-3014. doi: 10.1161/ATVBAHA.120.315757. Epub 2021 Oct 28.
Provided Documents
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Document Type: Statistical Analysis Plan
Document Type: Study Protocol
Related Links
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D7870C00002 Clinical Protocol Redacted
D7870C00002 Statistical Analysis Plan Redacted
Other Identifiers
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D7870C00002
Identifier Type: -
Identifier Source: org_study_id
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