Study to Assess In-home Use of Evolocumab (AMG 145) Using a Prefilled Syringe or a Prefilled Autoinjector/Pen



Status:Completed
Conditions:High Cholesterol
Therapuetic Areas:Cardiology / Vascular Diseases
Healthy:No
Age Range:18 - 80
Updated:12/1/2018
Start Date:April 18, 2013

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Trial Summary
Trial Overview
Inclusion Criteria

A Multi-center, Randomized Study in Subjects With Primary Hypercholesterolemia or Mixed Dyslipidemia to Assess Subjects' Ability to Administer a Full Dose of Evolocumab (AMG 145) in Home-use, Using Either a Prefilled Syringe or a Prefilled Autoinjector/Pen

The primary objective of this study was to assess users' ability to administer a full dose of
evolocumab in home-use using either a pre-filled syringe or autoinjector/pen.


Inclusion Criteria:

- Fasting LDL-C at screening > 85 mg/dL

- Fasting triglycerides less than or equal to 400 mg/dL (4.5 mmol/L) Exclusion Criteria:

- New York Heart Association (NYHA) III or IV heart failure

- Uncontrolled cardiac arrhythmia

- Uncontrolled hypertension

- Type 1 diabetes or poorly controlled type 2 diabetes

- Uncontrolled hypothyroidism or hyperthyroidism
We found this trial at
21
sites
Clinical Trial Facility in Thousand Oaks California
Thousand Oaks, California 91360
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Thousand Oaks, CA
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Clinical Trial Facility in Atlanta Georgia
Atlanta, Georgia
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Atlanta, GA
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Clinical Trial Facility in Auburn Maine
Auburn, Maine 04210
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Auburn, ME
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Clinical Trial Facility in Cadiz Ohio
Cadiz, Ohio 43907
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Cadiz, OH
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Clinical Trial Facility in Dallas Texas
Dallas, Texas 75390
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Dallas, TX
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Clinical Trial Facility in Duncansville Pennsylvania
Duncansville, Pennsylvania 16635
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Duncansville, PA
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Clinical Trial Facility in Encino California
Encino, California 91436
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Encino, CA
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Clinical Trial Facility in Hammond Indiana
Hammond, Indiana 46320
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Hammond, IN
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Clinical Trial Facility in Hillsboro Oregon
Hillsboro, Oregon 97123
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from
Hillsboro, OR
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Clinical Trial Facility in Houston Texas
Houston, Texas
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from
Houston, TX
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Clinical Trial Facility in Jackson Tennessee
Jackson, Tennessee 38305
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Jackson, TN
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Clinical Trial Facility in Lansdale Pennsylvania
Lansdale, Pennsylvania
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Lansdale, PA
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Clinical Trial Facility in London Ontario
London, Ontario
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from
London,
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Clinical Trial Facility in Manlius New York
Manlius, New York 13104
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Manlius, NY
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Clinical Trial Facility in Marion Ohio
Marion, Ohio 43302
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Marion, OH
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Clinical Trial Facility in Miami Florida
Miami, Florida 33136
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Miami, FL
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Clinical Trial Facility in Port Charlotte Florida
Port Charlotte, Florida 33952
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Port Charlotte, FL
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Clinical Trial Facility in Rapid City South Dakota
Rapid City, South Dakota 57701
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Rapid City, SD
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Clinical Trial Facility in Syracuse New York
Syracuse, New York 13202
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from
Syracuse, NY
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Clinical Trial Facility in Ventura California
Ventura, California 93003
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from
Ventura, CA
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Clinical Trial Facility in Westlake Village California
Westlake Village, California 91361
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from
Westlake Village, CA
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