Last updated on September 2017

An Extension Trial of Inclisiran Compared to Evolocumab in Participants With Cardiovascular Disease and High Cholesterol


Brief description of study

ORION-3 is a Phase II, open-label, non-randomized, active comparator extension trial to assess the efficacy, safety, and tolerability of long-term dosing of inclisiran and evolocumab given as subcutaneous injections in participants with high cardiovascular risk and elevated low-density lipoprotein cholesterol (LDL-C).

Detailed Study Description

ORION-3, an extension of study MDCO-PCS-15-01 (ORION-1) [NCT02597127], is a Phase II, placebo-controlled, double-blind, randomized trial to evaluate the efficacy, safety, and tolerability of inclisiran (ALN-PCSSC) injection(s). All participants who completed ORION-1 (at least up to and including Day 210) and meet the study criteria will be enrolled into this study. ORION-3 is a long-term extension trial with an active comparator (evolocumab) in participants with atherosclerotic cardiovascular disease (ASCVD) or ASCVD-risk equivalents (diabetes, familial hypercholesterolemia) and elevated LDL-C, despite maximum tolerated dose of LDL-C lowering therapies.

Clinical Study Identifier: NCT03060577

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Jacksonville Center for Clinical Research
Jacksonville, FL United States
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Mount Sinai Icahn School of Medicine
New York, NY United States
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Metabolic And Atherosclerosis Research Center
Cincinnati, OH United States
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Sterling Research Group
Cincinnati, OH United States
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Wellmont CVA Heart Institute
Greeneville, TN United States
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Amarillo Heart Clinical Research Institute, Inc.
Amarillo, TX United States
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National Clinical Research, Inc.
Richmond, VA United States
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Vancouver, BC Canada
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Saint John's, NL Canada
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Brampton, ON Canada
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Chicoutimi, QC Canada
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Clinique des maladies lipidique Quebec
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Goes, Netherlands
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Rotterdam, Netherlands
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Utrecht, Netherlands
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Utrecht, Netherlands
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Venlo, Netherlands
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