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

Primary Purpose

Hypercholesterolemia

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Evolocumab
Sponsored by
Amgen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hypercholesterolemia

Eligibility Criteria

18 Years - 99 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

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Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Evolocumab

Arm Description

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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

Full Information

First Posted
October 7, 2014
Last Updated
February 27, 2019
Sponsor
Amgen
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1. Study Identification

Unique Protocol Identification Number
NCT02304484
Brief Title
Open-label Extension (OLE) Study to Assess Safety and Efficacy of Evolocumab
Official Title
A Multicenter, Open-label Extension (OLE) Study to Assess the Long-term Safety and Efficacy of Evolocumab
Study Type
Interventional

2. Study Status

Record Verification Date
February 2019
Overall Recruitment Status
Completed
Study Start Date
November 24, 2014 (Actual)
Primary Completion Date
March 9, 2018 (Actual)
Study Completion Date
March 9, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Amgen

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypercholesterolemia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
770 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Evolocumab
Arm Type
Experimental
Arm Description
Participants received 420 mg evolocumab once a month for up to 2 years.
Intervention Type
Biological
Intervention Name(s)
Evolocumab
Other Intervention Name(s)
AMG 145, Repatha
Intervention Description
Administered by subcutaneous injection once a month
Primary Outcome Measure Information:
Title
Number of Participants With Adverse Events
Description
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.
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.
Secondary Outcome Measure Information:
Title
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

10. Eligibility

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

12. IPD Sharing Statement

Links:
URL
http://www.amgentrials.com
Description
AmgenTrials clinical trials website

Learn more about this trial

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

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