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

NCT02304484 | Completed Phase 3 Results DMC

• 2 other identifiers: 201401282014-001524-30
• Study Type: interventional
• Target: 770
• Locations: 29 countries
• Sites: 126

Brief Summary

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.

Conditions

Hypercholesterolemia

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Adverse Events

  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 Outcomes (1)

• Percent Change From Baseline in Low-density Lipoprotein Cholesterol (LDL-C)

  Baseline (of study 20120153) and weeks 0, 4, 12, 24, 36, 48, 52, 76, and 104 of study 20140128

Study Arms (1)

Evolocumab

EXPERIMENTAL

Participants received 420 mg evolocumab once a month for up to 2 years.

Biological: Evolocumab

Interventions

Evolocumab BIOLOGICAL

Administered by subcutaneous injection once a month

Also known as: AMG 145, Repatha

Evolocumab

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Completed week 80 of study 20120153 (NCT01813422).

You may not qualify if:

• 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)

Sponsors & Collaborators

• Amgen: lead

Study Sites (126)

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Huntsville, Alabama, 35801, United States

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Mobile, Alabama, 36608, United States

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Long Beach, California, 90822, United States

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San Diego, California, 92161, United States

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Torrance, California, 90502, United States

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Jacksonville, Florida, 32216, United States

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Munster, Indiana, 46321, United States

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Lexington, Kentucky, 40536, United States

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Covington, Louisiana, 70433, United States

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Bethesda, Maryland, 20814, United States

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Columbia, Maryland, 21044, United States

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Bay City, Michigan, 48708, United States

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Midland, Michigan, 48670, United States

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Duluth, Minnesota, 55805, United States

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Saint Cloud, Minnesota, 56303, United States

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Columbia, Missouri, 65212, United States

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Ridgewood, New Jersey, 07450, United States

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Fargo, North Dakota, 58122, United States

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Canton, Ohio, 44710, United States

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Toledo, Ohio, 43614, United States

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Oak Ridge, Tennessee, 37830, United States

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Amarillo, Texas, 79106, United States

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Dallas, Texas, 75216, United States

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Wichita Falls, Texas, 76301, United States

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La Plata, Buenos Aires, B1906EHD, Argentina

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Córdoba, Córdoba Province, X5016KEH, Argentina

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Córdoba, X5003DCE, Argentina

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Córdoba, X5021FPI, Argentina

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Liverpool, New South Wales, 2170, Australia

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New Lambton Heights, New South Wales, 2305, Australia

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Chermside, Queensland, 4032, Australia

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Herston, Queensland, 4029, Australia

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Adelaide, South Australia, 5000, Australia

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Fullarton, South Australia, 5063, Australia

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Epping, Victoria, 3076, Australia

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Footscray, Victoria, 3011, Australia

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Nedlands, Western Australia, 6009, Australia

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Antwerp, 2020, Belgium

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Edegem, 2650, Belgium

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Genk, 3600, Belgium

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Hasselt, 3500, Belgium

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Lodelinsart, 6042, Belgium

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Porto Alegre, Rio Grande do Sul, 90620-001, Brazil

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São Paulo, 05403-000, Brazil

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Calgary, Alberta, T2N 4Z6, Canada

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Victoria, British Columbia, V8R 4R2, Canada

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Winnipeg, Manitoba, R2H 2A6, Canada

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St. John's, Newfoundland and Labrador, A1B 3V6, Canada

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Halifax, Nova Scotia, B3H 3A7, Canada

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London, Ontario, N6A 5A5, Canada

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Toronto, Ontario, M5B 1W8, Canada

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Toronto, Ontario, M5G 2C4, Canada

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Laval, Quebec, H7M 3L9, Canada

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Montreal, Quebec, H1T 2M4, Canada

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Québec, Quebec, G1V 4G5, Canada

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Temuco, Cautín, 4781156, Chile

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Brno, 625 00, Czechia

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Hradec Králové, 500 05, Czechia

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Prague, 128 08, Czechia

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Zlín, 762 75, Czechia

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Besançon, 25030, France

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Chambray-lès-Tours, 37170, France

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Marseille, 13385, France

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Paris, 75015, France

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Pessac, 33604, France

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Essen, 45147, Germany

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Athens, 11527, Greece

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Athens, 14561, Greece

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Heraklion, 71110, Greece

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Budapest, 1023, Hungary

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Budapest, 1122, Hungary

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Budapest, 1134, Hungary

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Debrecen, 4032, Hungary

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Szeged, 6725, Hungary

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Reykjavik, 101, Iceland

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Galway, Ireland

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Hadera, 38100, Israel

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Jerusalem, 91031, Israel

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Novara, 28100, Italy

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Rozzano MI, 20089, Italy

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Sesto San Giovanni (MI), 20099, Italy

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Torino, 10154, Italy

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Kuantan, Pahang, 25100, Malaysia

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George Town, 10050, Malaysia

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Guadalajara, Jalisco, 44670, Mexico

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San Luis Potosí City, San Luis Potosí, 78240, Mexico

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Culiacán, Sinaloa, 80230, Mexico

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Aguascalientes, 20230, Mexico

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Alkmaar, 1815 JD, Netherlands

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Amsterdam, 1081 HV, Netherlands

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Amsterdam, 1091 AC, Netherlands

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Leeuwarden, 8934 AD, Netherlands

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Nijmegen, 6532 SZ, Netherlands

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Rotterdam, 3079 DZ, Netherlands

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Tilburg, 5042 AD, Netherlands

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Utrecht, 3508 GZ, Netherlands

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Zwolle, 8025 AB, Netherlands

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Oslo, 0424, Norway

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Chrzanów, 32-500, Poland

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Kędzierzyn-Koźle, 47-200, Poland

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Krakow, 31-202, Poland

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Krakow, 31-501, Poland

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Lodz, 90-549, Poland

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Warsaw, 04-628, Poland

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Kemerovo, 650002, Russia

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Moscow, 101990, Russia

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Moscow, 119991, Russia

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Moscow, 121552, Russia

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Centurion, Gauteng, 0157, South Africa

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Sunninghill, Gauteng, 2157, South Africa

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Kuils River, Western Cape, 7580, South Africa

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Daejeon, 301-723, South Korea

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Seongnam-si, Gyeonggi-do, 463-707, South Korea

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Seoul, 130-872, South Korea

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Seoul, 156-707, South Korea

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Málaga, Andalusia, 29010, Spain

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Barcelona, Catalonia, 08035, Spain

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L'Hospitalet de Llobregat, Catalonia, 08907, Spain

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Gijón, Principality of Asturias, 33394, Spain

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Madrid, 28034, Spain

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Madrid, 28046, Spain

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Gothenburg, 413 45, Sweden

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Stockholm, 171 76, Sweden

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Geneva, 1211, Switzerland

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New Taipei City, 251, Taiwan

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Newcastle upon Tyne, NE7 7DN, United Kingdom

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Related Links

• AmgenTrials clinical trials website

MeSH Terms

Conditions

Hypercholesterolemia

Interventions

evolocumab

Condition Hierarchy (Ancestors)

Hyperlipidemias; Dyslipidemias; Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Results Point of Contact

• Title: Study Director
• Organization: Amgen Inc.

medinfo@amgen.com

866-572-6436

Study Officials

• MD

  Amgen

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 7, 2014
• First Posted: December 2, 2014
• Study Start: November 24, 2014
• Primary Completion: March 9, 2018
• Study Completion: March 9, 2018
• Last Updated: March 19, 2019
• Results First Posted: March 19, 2019

Record last verified: 2019-02

Locations

HU (5); US (24); ES (6); CH (1); ME (4); TW (1); MY (2); RU (4); AR (4); CL (1); CZ (4); FR (5); IE (1); SE (2); BR (2); BE (5); IL (2); NL (9); NO (1); AU (9); PL (6); IC (1); ZA (3); GB (1); KR (4); GR (3); IT (4); CA (11); DE (1)