Open-label Extension (OLE) Study to Assess Safety and Efficacy of Evolocumab

February 27, 2019 updated by: Amgen

A Multicenter, Open-label Extension (OLE) Study to Assess the Long-term Safety and Efficacy of Evolocumab

The purpose of this study was to characterize the safety and tolerability of long-term administration of evolocumab in adults with known coronary artery disease and hypercholesterolemia.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

770

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Argentina
      • Córdoba, Argentina, X5003DCE
        • Research Site
      • Córdoba, Argentina, X5021FPI
        • Research Site
    • Buenos Aires
      • La Plata, Buenos Aires, Argentina, B1906EHD
        • Research Site
    • Córdoba
      • Cordoba, Córdoba, Argentina, X5016KEH
        • Research Site
  • Australia
    • New South Wales
      • Liverpool, New South Wales, Australia, 2170
        • Research Site
      • New Lambton Heights, New South Wales, Australia, 2305
        • Research Site
    • Queensland
      • Chermside, Queensland, Australia, 4032
        • Research Site
      • Herston, Queensland, Australia, 4029
        • Research Site
    • South Australia
      • Adelaide, South Australia, Australia, 5000
        • Research Site
      • Fullarton, South Australia, Australia, 5063
        • Research Site
    • Victoria
      • Epping, Victoria, Australia, 3076
        • Research Site
      • Footscray, Victoria, Australia, 3011
        • Research Site
    • Western Australia
      • Nedlands, Western Australia, Australia, 6009
        • Research Site
  • Belgium
      • Antwerpen, Belgium, 2020
        • Research Site
      • Edegem, Belgium, 2650
        • Research Site
      • Genk, Belgium, 3600
        • Research Site
      • Hasselt, Belgium, 3500
        • Research Site
      • Lodelinsart, Belgium, 6042
        • Research Site
  • Brazil
      • São Paulo, Brazil, 05403-000
        • Research Site
    • Rio Grande Do Sul
      • Porto Alegre, Rio Grande Do Sul, Brazil, 90620-001
        • Research Site
  • Canada
    • Alberta
      • Calgary, Alberta, Canada, T2N 4Z6
        • Research Site
    • British Columbia
      • Victoria, British Columbia, Canada, V8R 4R2
        • Research Site
    • Manitoba
      • Winnipeg, Manitoba, Canada, R2H 2A6
        • Research Site
    • Newfoundland and Labrador
      • St. Johns, Newfoundland and Labrador, Canada, A1B 3V6
        • Research Site
    • Nova Scotia
      • Halifax, Nova Scotia, Canada, B3H 3A7
        • Research Site
    • Ontario
      • London, Ontario, Canada, N6A 5A5
        • Research Site
      • Toronto, Ontario, Canada, M5G 2C4
        • Research Site
      • Toronto, Ontario, Canada, M5B 1W8
        • Research Site
    • Quebec
      • Laval, Quebec, Canada, H7M 3L9
        • Research Site
      • Montreal, Quebec, Canada, H1T 2M4
        • Research Site
      • Québec, Quebec, Canada, G1V 4G5
        • Research Site
  • Chile
    • Cautín
      • Temuco, Cautín, Chile, 4781156
        • Research Site
  • Czechia
      • Brno, Czechia, 625 00
        • Research Site
      • Hradec Kralove, Czechia, 500 05
        • Research Site
      • Praha 2, Czechia, 128 08
        • Research Site
      • Zlin, Czechia, 762 75
        • Research Site
  • France
      • Besancon cedex, France, 25030
        • Research Site
      • Chambray les Tours, France, 37170
        • Research Site
      • Marseille cedex 5, France, 13385
        • Research Site
      • Paris, France, 75015
        • Research Site
      • Pessac Cedex, France, 33604
        • Research Site
  • Germany
      • Essen, Germany, 45147
        • Research Site
  • Greece
      • Athens, Greece, 11527
        • Research Site
      • Athens, Greece, 14561
        • Research Site
      • Heraklion, Greece, 71110
        • Research Site
  • Hungary
      • Budapest, Hungary, 1122
        • Research Site
      • Budapest, Hungary, 1134
        • Research Site
      • Budapest, Hungary, 1023
        • Research Site
      • Debrecen, Hungary, 4032
        • Research Site
      • Szeged, Hungary, 6725
        • Research Site
  • Iceland
      • Reykjavik, Iceland, 101
        • Research Site
  • Ireland
      • Galway, Ireland
        • Research Site
  • Israel
      • Hadera, Israel, 38100
        • Research Site
      • Jerusalem, Israel, 91031
        • Research Site
  • Italy
      • Novara, Italy, 28100
        • Research Site
      • Rozzano MI, Italy, 20089
        • Research Site
      • Sesto San Giovanni (MI), Italy, 20099
        • Research Site
      • Torino, Italy, 10154
        • Research Site
  • Korea, Republic of
      • Daejeon, Korea, Republic of, 301-723
        • Research Site
      • Seongnam-si, Gyeonggi-do, Korea, Republic of, 463-707
        • Research Site
      • Seoul, Korea, Republic of, 156-707
        • Research Site
      • Seoul, Korea, Republic of, 130-872
        • Research Site
  • Malaysia
      • Penang, Malaysia, 10050
        • Research Site
    • Pahang
      • Kuantan, Pahang, Malaysia, 25100
        • Research Site
  • Mexico
      • Aguascalientes, Mexico, 20230
        • Research Site
    • Jalisco
      • Guadalajara, Jalisco, Mexico, 44670
        • Research Site
    • San Luis Potosí
      • San Luis Potosi, San Luis Potosí, Mexico, 78240
        • Research Site
    • Sinaloa
      • Culiacan, Sinaloa, Mexico, 80230
        • Research Site
  • Netherlands
      • Alkmaar, Netherlands, 1815 JD
        • Research Site
      • Amsterdam, Netherlands, 1081 HV
        • Research Site
      • Amsterdam, Netherlands, 1091 AC
        • Research Site
      • Leeuwarden, Netherlands, 8934 AD
        • Research Site
      • Nijmegen, Netherlands, 6532 SZ
        • Research Site
      • Rotterdam, Netherlands, 3079 DZ
        • Research Site
      • Tilburg, Netherlands, 5042 AD
        • Research Site
      • Utrecht, Netherlands, 3508 GZ
        • Research Site
      • Zwolle, Netherlands, 8025 AB
        • Research Site
  • Norway
      • Oslo, Norway, 0424
        • Research Site
  • Poland
      • Chrzanow, Poland, 32-500
        • Research Site
      • Kedzierzyn Kozle, Poland, 47-200
        • Research Site
      • Krakow, Poland, 31-501
        • Research Site
      • Krakow, Poland, 31-202
        • Research Site
      • Lodz, Poland, 90-549
        • Research Site
      • Warszawa, Poland, 04-628
        • Research Site
  • Russian Federation
      • Kemerovo, Russian Federation, 650002
        • Research Site
      • Moscow, Russian Federation, 101990
        • Research Site
      • Moscow, Russian Federation, 119991
        • Research Site
      • Moscow, Russian Federation, 121552
        • Research Site
  • South Africa
    • Gauteng
      • Centurion, Gauteng, South Africa, 0157
        • Research Site
      • Sunninghill, Gauteng, South Africa, 2157
        • Research Site
    • Western Cape
      • Kuils River, Western Cape, South Africa, 7580
        • Research Site
  • Spain
      • Madrid, Spain, 28034
        • Research Site
      • Madrid, Spain, 28046
        • Research Site
    • Andalucía
      • Malaga, Andalucía, Spain, 29010
        • Research Site
    • Asturias
      • Gijon, Asturias, Spain, 33394
        • Research Site
    • Cataluña
      • Barcelona, Cataluña, Spain, 08035
        • Research Site
      • L Hospitalet De Llobregat, Cataluña, Spain, 08907
        • Research Site
  • Sweden
      • Göteborg, Sweden, 413 45
        • Research Site
      • Stockholm, Sweden, 171 76
        • Research Site
  • Switzerland
      • Geneva 14, Switzerland, 1211
        • Research Site
  • Taiwan
      • New Taipei, Taiwan, 251
        • Research Site
  • United Kingdom
      • Newcastle Upon Tyne, United Kingdom, NE7 7DN
        • Research Site
  • United States
    • Alabama
      • Huntsville, Alabama, United States, 35801
        • Research Site
      • Mobile, Alabama, United States, 36608
        • Research Site
    • California
      • Long Beach, California, United States, 90822
        • Research Site
      • San Diego, California, United States, 92161
        • Research Site
      • Torrance, California, United States, 90502
        • Research Site
    • Florida
      • Jacksonville, Florida, United States, 32216
        • Research Site
    • Indiana
      • Munster, Indiana, United States, 46321
        • Research Site
    • Kentucky
      • Lexington, Kentucky, United States, 40536
        • Research Site
    • Louisiana
      • Covington, Louisiana, United States, 70433
        • Research Site
    • Maryland
      • Bethesda, Maryland, United States, 20814
        • Research Site
      • Columbia, Maryland, United States, 21044
        • Research Site
    • Michigan
      • Bay City, Michigan, United States, 48708
        • Research Site
      • Midland, Michigan, United States, 48670
        • Research Site
    • Minnesota
      • Duluth, Minnesota, United States, 55805
        • Research Site
      • Saint Cloud, Minnesota, United States, 56303
        • Research Site
    • Missouri
      • Columbia, Missouri, United States, 65212
        • Research Site
    • New Jersey
      • Ridgewood, New Jersey, United States, 07450
        • Research Site
    • North Dakota
      • Fargo, North Dakota, United States, 58122
        • Research Site
    • Ohio
      • Canton, Ohio, United States, 44710
        • Research Site
      • Toledo, Ohio, United States, 43614
        • Research Site
    • Tennessee
      • Oak Ridge, Tennessee, United States, 37830
        • Research Site
    • Texas
      • Amarillo, Texas, United States, 79106
        • Research Site
      • Dallas, Texas, United States, 75216
        • Research Site
      • Wichita Falls, Texas, United States, 76301
        • Research Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 99 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Completed week 80 of study 20120153 (NCT01813422).

Exclusion Criteria:

  • Did not complete investigational product in the 20120153 parent study
  • Have an unstable medical condition, in the judgment of the investigator
  • Known sensitivity to any of the products to be administered during dosing
  • Currently enrolled in another investigational device or drug study (excluding evolocumab (AMG 145) parent study), or less than 30 days since ending another investigational device or drug study(s),or receiving other investigational agent(s)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Evolocumab
Participants received 420 mg evolocumab once a month for up to 2 years.
Biological: Evolocumab
Administered by subcutaneous injection once a month
Other Names:
  • Repatha
  • AMG 145

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants With Adverse Events
Time Frame: From first dose of evolocumab up to 30 days after the last dose, or end of study, whichever was earlier, up to 108 weeks.

The severity of each adverse event (AE) was graded using the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 criteria, where Grade 1 = Mild AE, Grade 2 = Moderate AE, Grade 3 = Severe or medically significant AE, Grade 4 = Life-threatening consequences, and Grade 5 = death related to AE.

An adverse device effect was defined as any adverse event related to the use of a medical device (autoinjector/pen or automated mini doser [AMD]), including but not limited to, AEs resulting from insufficient or inadequate Instructions for Use, AEs resulting from any malfunction of the device, or AEs resulting from use error or from intentional misuse of the device.
From first dose of evolocumab up to 30 days after the last dose, or end of study, whichever was earlier, up to 108 weeks.

Secondary Outcome Measures

Outcome Measure
Time Frame
Percent Change From Baseline in Low-density Lipoprotein Cholesterol (LDL-C)
Time Frame: Baseline (of study 20120153) and weeks 0, 4, 12, 24, 36, 48, 52, 76, and 104 of study 20140128
Baseline (of study 20120153) and weeks 0, 4, 12, 24, 36, 48, 52, 76, and 104 of study 20140128

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Amgen

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 24, 2014

Primary Completion (Actual)

March 9, 2018

Study Completion (Actual)

March 9, 2018

Study Registration Dates

First Submitted

October 7, 2014

First Submitted That Met QC Criteria

November 26, 2014

First Posted (Estimate)

December 2, 2014

Study Record Updates

Last Update Posted (Actual)

March 19, 2019

Last Update Submitted That Met QC Criteria

February 27, 2019

Last Verified

February 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20140128
  • 2014-001524-30 (EudraCT Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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