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Open-label Extension Study of Evolocumab (AMG 145) in Adults With Hyperlipidemia and Mixed Dyslipidemia (OSLER-2)

Primary Purpose

Hyperlipidemia and Mixed Dyslipidemia

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

About this trial

This is an interventional treatment trial for Hyperlipidemia and Mixed Dyslipidemia focused on measuring High cholesterol, Raised cholesterol, Cholesterol, Elevated Cholesterol

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

- Complete a qualifying evolocumab (AMG 145) parent study (ie, Study 20110114 [NCT01763827], 20110115 [NCT01763866], 20110116 [NCT01763905], 20110117 [NCT01763918], 20110109 [NCT01516879], 20120122 [NCT01953328], 20120332 [NCT01984424], 20120348 [NCT01849497], or 20120356 [NCT01879319]).

Exclusion Criteria:

  • Experienced a treatment-related serious adverse event that led to study drug discontinuation in the 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 2

Arm Type

Active Comparator

Experimental

Arm Label

Standard of Care

Evolocumab + Standard of Care

Arm Description

Participants received standard of care (SOC) treatment for the first year of the study (SOC-controlled period). At week 48, participants began treatment with evolocumab at a dose of either 140 mg every 2 weeks (Q2W) or 420 mg every month (QM), based on participant choice, for approximately 2 years during the all-investigational product [all-IP] period.

Participants received subcutaneous evolocumab plus standard of care during the first year of the study (SOC-controlled period) and for approximately 2 years during the all-IP period. Evolocumab was administered at a dose of 140 mg every 2 weeks (Q2W) or 420 mg every month (QM) based on participant choice.

Outcomes

Primary Outcome Measures

Number of Participants With Adverse Events
Adverse event (AE) severity assessments were made using National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) grading, version 4.0, where grade 1 = mild AE, grade 2 = moderate AE, Grade 3 = severe AE, grade 4 = life-threatening AE and Grade 5 = death due to AE.

Secondary Outcome Measures

Percent Change From Baseline in LDL-C at Weeks 48 and 104
Change From Baseline in LDL-C at Weeks 48 and 104

Full Information

First Posted
May 1, 2013
Last Updated
May 20, 2019
Sponsor
Amgen
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1. Study Identification

Unique Protocol Identification Number
NCT01854918
Brief Title
Open-label Extension Study of Evolocumab (AMG 145) in Adults With Hyperlipidemia and Mixed Dyslipidemia
Acronym
OSLER-2
Official Title
A Multicenter, Controlled, Open-label Extension (OLE) Study to Assess the Long-term Safety and Efficacy of AMG 145
Study Type
Interventional

2. Study Status

Record Verification Date
May 2019
Overall Recruitment Status
Completed
Study Start Date
April 23, 2013 (Actual)
Primary Completion Date
May 31, 2018 (Actual)
Study Completion Date
May 31, 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
This study will contribute to the evaluation of long-term safety, tolerability and efficacy of evolocumab (AMG 145) in adults with hyperlipidemia and adults with mixed dyslipidemia.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hyperlipidemia and Mixed Dyslipidemia
Keywords
High cholesterol, Raised cholesterol, Cholesterol, Elevated Cholesterol

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
3681 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Standard of Care
Arm Type
Active Comparator
Arm Description
Participants received standard of care (SOC) treatment for the first year of the study (SOC-controlled period). At week 48, participants began treatment with evolocumab at a dose of either 140 mg every 2 weeks (Q2W) or 420 mg every month (QM), based on participant choice, for approximately 2 years during the all-investigational product [all-IP] period.
Arm Title
Evolocumab + Standard of Care
Arm Type
Experimental
Arm Description
Participants received subcutaneous evolocumab plus standard of care during the first year of the study (SOC-controlled period) and for approximately 2 years during the all-IP period. Evolocumab was administered at a dose of 140 mg every 2 weeks (Q2W) or 420 mg every month (QM) based on participant choice.
Intervention Type
Biological
Intervention Name(s)
Evolocumab
Other Intervention Name(s)
AMG 145, Repatha
Intervention Description
Administered by subcutaneous injection either every 2 weeks or once a month (patient preference) using a prefilled autoinjector pen
Intervention Type
Drug
Intervention Name(s)
Standard of Care
Intervention Description
Standard of care therapy as per local practices. This could include prescribed therapies and/or dietary/exercise regimes
Primary Outcome Measure Information:
Title
Number of Participants With Adverse Events
Description
Adverse event (AE) severity assessments were made using National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) grading, version 4.0, where grade 1 = mild AE, grade 2 = moderate AE, Grade 3 = severe AE, grade 4 = life-threatening AE and Grade 5 = death due to AE.
Time Frame
48 weeks in the SOC-controlled period and up to 2 years in the All-IP period
Secondary Outcome Measure Information:
Title
Percent Change From Baseline in LDL-C at Weeks 48 and 104
Time Frame
Baseline of the parent study and weeks 48 amd 104
Title
Change From Baseline in LDL-C at Weeks 48 and 104
Time Frame
Baseline of the parent study and weeks 48 amd 104

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: - Complete a qualifying evolocumab (AMG 145) parent study (ie, Study 20110114 [NCT01763827], 20110115 [NCT01763866], 20110116 [NCT01763905], 20110117 [NCT01763918], 20110109 [NCT01516879], 20120122 [NCT01953328], 20120332 [NCT01984424], 20120348 [NCT01849497], or 20120356 [NCT01879319]). Exclusion Criteria: Experienced a treatment-related serious adverse event that led to study drug discontinuation in the 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
Birmingham
State/Province
Alabama
ZIP/Postal Code
35216
Country
United States
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Research Site
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35294
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United States
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Research Site
City
Chandler
State/Province
Arizona
ZIP/Postal Code
85224
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United States
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Research Site
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Phoenix
State/Province
Arizona
ZIP/Postal Code
85020
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United States
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Research Site
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Tucson
State/Province
Arizona
ZIP/Postal Code
85712
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United States
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Research Site
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Little Rock
State/Province
Arkansas
ZIP/Postal Code
72205
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United States
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Beverly Hills
State/Province
California
ZIP/Postal Code
90211
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United States
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Research Site
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Carmichael
State/Province
California
ZIP/Postal Code
95608
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United States
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Research Site
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Encinitas
State/Province
California
ZIP/Postal Code
92024
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United States
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Huntington Beach
State/Province
California
ZIP/Postal Code
92648
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United States
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Los Angeles
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California
ZIP/Postal Code
90048
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United States
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Mission Viejo
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California
ZIP/Postal Code
92691
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United States
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Newport Beach
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California
ZIP/Postal Code
92663
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United States
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San Diego
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California
ZIP/Postal Code
92111
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United States
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Santa Ana
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California
ZIP/Postal Code
92705
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United States
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Santa Rosa
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California
ZIP/Postal Code
95405
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United States
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Spring Valley
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California
ZIP/Postal Code
91978
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United States
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Thousand Oaks
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California
ZIP/Postal Code
91360
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United States
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Torrance
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California
ZIP/Postal Code
90509
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United States
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Tustin
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California
ZIP/Postal Code
92780
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United States
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Ventura
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California
ZIP/Postal Code
93003
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United States
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Littleton
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Colorado
ZIP/Postal Code
80120
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United States
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Daytona Beach
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Florida
ZIP/Postal Code
32117
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United States
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DeLand
State/Province
Florida
ZIP/Postal Code
32720
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United States
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Jacksonville
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Florida
ZIP/Postal Code
32216
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United States
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Melbourne
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Florida
ZIP/Postal Code
32901
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United States
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Research Site
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Miami
State/Province
Florida
ZIP/Postal Code
33144
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United States
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Research Site
City
Miami
State/Province
Florida
ZIP/Postal Code
33173
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United States
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Research Site
City
Ponte Vedra
State/Province
Florida
ZIP/Postal Code
32081
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United States
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Research Site
City
Port Charlotte
State/Province
Florida
ZIP/Postal Code
33952
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United States
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Research Site
City
Sanford
State/Province
Florida
ZIP/Postal Code
32771
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United States
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Atlanta
State/Province
Georgia
ZIP/Postal Code
30328
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United States
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Research Site
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30338
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United States
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Research Site
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30342
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United States
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Gainesville
State/Province
Georgia
ZIP/Postal Code
30501
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United States
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Savannah
State/Province
Georgia
ZIP/Postal Code
31406
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United States
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Chicago
State/Province
Illinois
ZIP/Postal Code
60654
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United States
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Sterling
State/Province
Illinois
ZIP/Postal Code
61081
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United States
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Indianapolis
State/Province
Indiana
ZIP/Postal Code
46260
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United States
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Munster
State/Province
Indiana
ZIP/Postal Code
46321
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United States
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Research Site
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Iowa City
State/Province
Iowa
ZIP/Postal Code
52242
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United States
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Research Site
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Kansas City
State/Province
Kansas
ZIP/Postal Code
66160
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United States
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Lexington
State/Province
Kentucky
ZIP/Postal Code
40504
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United States
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Research Site
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Louisville
State/Province
Kentucky
ZIP/Postal Code
40213
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United States
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Research Site
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Monroe
State/Province
Louisiana
ZIP/Postal Code
71201
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United States
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Research Site
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Auburn
State/Province
Maine
ZIP/Postal Code
04210
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United States
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Research Site
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Bangor
State/Province
Maine
ZIP/Postal Code
04401
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United States
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Portland
State/Province
Maine
ZIP/Postal Code
04101
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United States
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Bethesda
State/Province
Maryland
ZIP/Postal Code
20817
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United States
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Columbia
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Maryland
ZIP/Postal Code
21045
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United States
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Towson
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Maryland
ZIP/Postal Code
21204
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United States
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Ayer
State/Province
Massachusetts
ZIP/Postal Code
01432
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United States
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Quincy
State/Province
Massachusetts
ZIP/Postal Code
02169
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United States
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Ypsilanti
State/Province
Michigan
ZIP/Postal Code
48197
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United States
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Edina
State/Province
Minnesota
ZIP/Postal Code
55435
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United States
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Research Site
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Olive Branch
State/Province
Mississippi
ZIP/Postal Code
38654
Country
United States
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Research Site
City
Tupelo
State/Province
Mississippi
ZIP/Postal Code
38801
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United States
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Research Site
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
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United States
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Research Site
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Henderson
State/Province
Nevada
ZIP/Postal Code
89052
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United States
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Research Site
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Las Vegas
State/Province
Nevada
ZIP/Postal Code
89148
Country
United States
Facility Name
Research Site
City
Endwell
State/Province
New York
ZIP/Postal Code
13760
Country
United States
Facility Name
Research Site
City
Manlius
State/Province
New York
ZIP/Postal Code
13104
Country
United States
Facility Name
Research Site
City
New Windsor
State/Province
New York
ZIP/Postal Code
12553
Country
United States
Facility Name
Research Site
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States
Facility Name
Research Site
City
Rochester
State/Province
New York
ZIP/Postal Code
14609
Country
United States
Facility Name
Research Site
City
Williamsville
State/Province
New York
ZIP/Postal Code
14221
Country
United States
Facility Name
Research Site
City
Raleigh
State/Province
North Carolina
ZIP/Postal Code
27609
Country
United States
Facility Name
Research Site
City
Raleigh
State/Province
North Carolina
ZIP/Postal Code
27612
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United States
Facility Name
Research Site
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27103
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United States
Facility Name
Research Site
City
Fargo
State/Province
North Dakota
ZIP/Postal Code
58103
Country
United States
Facility Name
Research Site
City
Akron
State/Province
Ohio
ZIP/Postal Code
44311
Country
United States
Facility Name
Research Site
City
Cadiz
State/Province
Ohio
ZIP/Postal Code
43907
Country
United States
Facility Name
Research Site
City
Canton
State/Province
Ohio
ZIP/Postal Code
44710
Country
United States
Facility Name
Research Site
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45219
Country
United States
Facility Name
Research Site
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45227
Country
United States
Facility Name
Research Site
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45236
Country
United States
Facility Name
Research Site
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Facility Name
Research Site
City
Dayton
State/Province
Ohio
ZIP/Postal Code
45414
Country
United States
Facility Name
Research Site
City
Mansfield
State/Province
Ohio
ZIP/Postal Code
44906
Country
United States
Facility Name
Research Site
City
Marion
State/Province
Ohio
ZIP/Postal Code
43302
Country
United States
Facility Name
Research Site
City
Sandusky
State/Province
Ohio
ZIP/Postal Code
44870
Country
United States
Facility Name
Research Site
City
Norman
State/Province
Oklahoma
ZIP/Postal Code
73069
Country
United States
Facility Name
Research Site
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73103
Country
United States
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Research Site
City
Hillsboro
State/Province
Oregon
ZIP/Postal Code
97123
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United States
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Research Site
City
Duncansville
State/Province
Pennsylvania
ZIP/Postal Code
16635
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United States
Facility Name
Research Site
City
Lansdale
State/Province
Pennsylvania
ZIP/Postal Code
19446
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United States
Facility Name
Research Site
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15216
Country
United States
Facility Name
Research Site
City
York
State/Province
Pennsylvania
ZIP/Postal Code
17405
Country
United States
Facility Name
Research Site
City
Anderson
State/Province
South Carolina
ZIP/Postal Code
29621
Country
United States
Facility Name
Research Site
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29425
Country
United States
Facility Name
Research Site
City
Mount Pleasant
State/Province
South Carolina
ZIP/Postal Code
29464
Country
United States
Facility Name
Research Site
City
Rapid City
State/Province
South Dakota
ZIP/Postal Code
57701
Country
United States
Facility Name
Research Site
City
Rapid City
State/Province
South Dakota
ZIP/Postal Code
57702
Country
United States
Facility Name
Research Site
City
Jackson
State/Province
Tennessee
ZIP/Postal Code
38305
Country
United States
Facility Name
Research Site
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37203
Country
United States
Facility Name
Research Site
City
Austin
State/Province
Texas
ZIP/Postal Code
78731
Country
United States
Facility Name
Research Site
City
Dallas
State/Province
Texas
ZIP/Postal Code
75230
Country
United States
Facility Name
Research Site
City
Dallas
State/Province
Texas
ZIP/Postal Code
75231
Country
United States
Facility Name
Research Site
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Research Site
City
Houston
State/Province
Texas
ZIP/Postal Code
77074
Country
United States
Facility Name
Research Site
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
Research Site
City
Norfolk
State/Province
Virginia
ZIP/Postal Code
23502
Country
United States
Facility Name
Research Site
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23294
Country
United States
Facility Name
Research Site
City
Suffolk
State/Province
Virginia
ZIP/Postal Code
23435
Country
United States
Facility Name
Research Site
City
Renton
State/Province
Washington
ZIP/Postal Code
98057
Country
United States
Facility Name
Research Site
City
Seattle
State/Province
Washington
ZIP/Postal Code
98104
Country
United States
Facility Name
Research Site
City
Tacoma
State/Province
Washington
ZIP/Postal Code
98405
Country
United States
Facility Name
Research Site
City
Camperdown
State/Province
New South Wales
ZIP/Postal Code
2015
Country
Australia
Facility Name
Research Site
City
Maroubra
State/Province
New South Wales
ZIP/Postal Code
2035
Country
Australia
Facility Name
Research Site
City
Sydney
State/Province
New South Wales
ZIP/Postal Code
2010
Country
Australia
Facility Name
Research Site
City
Sydney
State/Province
New South Wales
ZIP/Postal Code
2022
Country
Australia
Facility Name
Research Site
City
Auchenflower
State/Province
Queensland
ZIP/Postal Code
4066
Country
Australia
Facility Name
Research Site
City
Carina Heights
State/Province
Queensland
ZIP/Postal Code
4152
Country
Australia
Facility Name
Research Site
City
Sherwood
State/Province
Queensland
ZIP/Postal Code
4075
Country
Australia
Facility Name
Research Site
City
Woolloongabba
State/Province
Queensland
ZIP/Postal Code
4102
Country
Australia
Facility Name
Research Site
City
Ashford
State/Province
South Australia
ZIP/Postal Code
5035
Country
Australia
Facility Name
Research Site
City
Fullarton
State/Province
South Australia
ZIP/Postal Code
5063
Country
Australia
Facility Name
Research Site
City
Heidelberg Heights
State/Province
Victoria
ZIP/Postal Code
3081
Country
Australia
Facility Name
Research Site
City
Melbourne
State/Province
Victoria
ZIP/Postal Code
3004
Country
Australia
Facility Name
Research Site
City
Perth
State/Province
Western Australia
ZIP/Postal Code
6000
Country
Australia
Facility Name
Research Site
City
Salzburg
ZIP/Postal Code
5020
Country
Austria
Facility Name
Research Site
City
Anthée
ZIP/Postal Code
5520
Country
Belgium
Facility Name
Research Site
City
Blankenberge
ZIP/Postal Code
8370
Country
Belgium
Facility Name
Research Site
City
Bruxelles
ZIP/Postal Code
1080
Country
Belgium
Facility Name
Research Site
City
Bruxelles
ZIP/Postal Code
1200
Country
Belgium
Facility Name
Research Site
City
Chênée
ZIP/Postal Code
4032
Country
Belgium
Facility Name
Research Site
City
Gent
ZIP/Postal Code
9000
Country
Belgium
Facility Name
Research Site
City
Gozee
ZIP/Postal Code
6534
Country
Belgium
Facility Name
Research Site
City
Gribomont
ZIP/Postal Code
6887
Country
Belgium
Facility Name
Research Site
City
Halen
ZIP/Postal Code
3545
Country
Belgium
Facility Name
Research Site
City
Ham
ZIP/Postal Code
3945
Country
Belgium
Facility Name
Research Site
City
Hasselt
ZIP/Postal Code
3500
Country
Belgium
Facility Name
Research Site
City
La Louvière
ZIP/Postal Code
7100
Country
Belgium
Facility Name
Research Site
City
Linkebeek
ZIP/Postal Code
1630
Country
Belgium
Facility Name
Research Site
City
Oostende
ZIP/Postal Code
8400
Country
Belgium
Facility Name
Research Site
City
Tessenderlo
ZIP/Postal Code
3980
Country
Belgium
Facility Name
Research Site
City
Tremelo
ZIP/Postal Code
3120
Country
Belgium
Facility Name
Research Site
City
Vilvoorde
ZIP/Postal Code
1800
Country
Belgium
Facility Name
Research Site
City
Burnaby
State/Province
British Columbia
ZIP/Postal Code
V5G 1T4
Country
Canada
Facility Name
Research Site
City
Kelowna
State/Province
British Columbia
ZIP/Postal Code
V1Y 1V6
Country
Canada
Facility Name
Research Site
City
Surrey
State/Province
British Columbia
ZIP/Postal Code
V3V 1N1
Country
Canada
Facility Name
Research Site
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V6Z 1Y6
Country
Canada
Facility Name
Research Site
City
Bay Roberts
State/Province
Newfoundland and Labrador
ZIP/Postal Code
A0A 1G0
Country
Canada
Facility Name
Research Site
City
Mount Pearl
State/Province
Newfoundland and Labrador
ZIP/Postal Code
A1N 1W7
Country
Canada
Facility Name
Research Site
City
St. John's
State/Province
Newfoundland and Labrador
ZIP/Postal Code
A1A 3R5
Country
Canada
Facility Name
Research Site
City
Cambridge
State/Province
Ontario
ZIP/Postal Code
N1R 6V6
Country
Canada
Facility Name
Research Site
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8L 2X2
Country
Canada
Facility Name
Research Site
City
London
State/Province
Ontario
ZIP/Postal Code
N5W 6A2
Country
Canada
Facility Name
Research Site
City
London
State/Province
Ontario
ZIP/Postal Code
N6A 5K8
Country
Canada
Facility Name
Research Site
City
Newmarket
State/Province
Ontario
ZIP/Postal Code
L3Y 5G8
Country
Canada
Facility Name
Research Site
City
Oshawa
State/Province
Ontario
ZIP/Postal Code
L1J 2K1
Country
Canada
Facility Name
Research Site
City
Peterborough
State/Province
Ontario
ZIP/Postal Code
K9J 0B2
Country
Canada
Facility Name
Research Site
City
Sarnia
State/Province
Ontario
ZIP/Postal Code
N7T 4X3
Country
Canada
Facility Name
Research Site
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M8V 3X8
Country
Canada
Facility Name
Research Site
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M9V 4B4
Country
Canada
Facility Name
Research Site
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M9W 4L6
Country
Canada
Facility Name
Research Site
City
Woodstock
State/Province
Ontario
ZIP/Postal Code
N4S 5P5
Country
Canada
Facility Name
Research Site
City
Chicoutimi
State/Province
Quebec
ZIP/Postal Code
G7H 7K9
Country
Canada
Facility Name
Research Site
City
Granby
State/Province
Quebec
ZIP/Postal Code
J2G 8Z9
Country
Canada
Facility Name
Research Site
City
Greenfield Park
State/Province
Quebec
ZIP/Postal Code
J4V 2G8
Country
Canada
Facility Name
Research Site
City
Lachine
State/Province
Quebec
ZIP/Postal Code
H8S 2E4
Country
Canada
Facility Name
Research Site
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H2W 1R7
Country
Canada
Facility Name
Research Site
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H3A 1A1
Country
Canada
Facility Name
Research Site
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H4N 2W2
Country
Canada
Facility Name
Research Site
City
Pointe-Claire
State/Province
Quebec
ZIP/Postal Code
H9R 3J1
Country
Canada
Facility Name
Research Site
City
Quebec
ZIP/Postal Code
G1V 4M6
Country
Canada
Facility Name
Research Site
City
Brno
ZIP/Postal Code
602 00
Country
Czechia
Facility Name
Research Site
City
Brno
ZIP/Postal Code
603 00
Country
Czechia
Facility Name
Research Site
City
Chomutov
ZIP/Postal Code
430 02
Country
Czechia
Facility Name
Research Site
City
Hradec Kralove
ZIP/Postal Code
500 05
Country
Czechia
Facility Name
Research Site
City
Kladno
ZIP/Postal Code
272 01
Country
Czechia
Facility Name
Research Site
City
Litomerice
ZIP/Postal Code
412 01
Country
Czechia
Facility Name
Research Site
City
Moravske Budejovice
ZIP/Postal Code
676 02
Country
Czechia
Facility Name
Research Site
City
Olomouc
ZIP/Postal Code
775 20
Country
Czechia
Facility Name
Research Site
City
Pardubice
ZIP/Postal Code
530 02
Country
Czechia
Facility Name
Research Site
City
Plzen
ZIP/Postal Code
305 99
Country
Czechia
Facility Name
Research Site
City
Praha 2
ZIP/Postal Code
128 08
Country
Czechia
Facility Name
Research Site
City
Praha 3
ZIP/Postal Code
130 00
Country
Czechia
Facility Name
Research Site
City
Praha 4
ZIP/Postal Code
140 21
Country
Czechia
Facility Name
Research Site
City
Praha 5
ZIP/Postal Code
150 06
Country
Czechia
Facility Name
Research Site
City
Slany
ZIP/Postal Code
274 01
Country
Czechia
Facility Name
Research Site
City
Svitavy
ZIP/Postal Code
568 25
Country
Czechia
Facility Name
Research Site
City
Aalborg
ZIP/Postal Code
9000
Country
Denmark
Facility Name
Research Site
City
Aarhus N
ZIP/Postal Code
8200
Country
Denmark
Facility Name
Research Site
City
Ballerup
ZIP/Postal Code
2750
Country
Denmark
Facility Name
Research Site
City
Glostrup
ZIP/Postal Code
2600
Country
Denmark
Facility Name
Research Site
City
Vejle
ZIP/Postal Code
7100
Country
Denmark
Facility Name
Research Site
City
Brest Cedex 2
ZIP/Postal Code
29200
Country
France
Facility Name
Research Site
City
Bron
ZIP/Postal Code
69677
Country
France
Facility Name
Research Site
City
Caen Cedex 9
ZIP/Postal Code
14033
Country
France
Facility Name
Research Site
City
Dijon
ZIP/Postal Code
21034
Country
France
Facility Name
Research Site
City
Montpellier cedex 05
ZIP/Postal Code
34295
Country
France
Facility Name
Research Site
City
Nantes Cedex 1
ZIP/Postal Code
44093
Country
France
Facility Name
Research Site
City
Paris Cedex 12
ZIP/Postal Code
75571
Country
France
Facility Name
Research Site
City
Paris Cedex 13
ZIP/Postal Code
75651
Country
France
Facility Name
Research Site
City
Vénissieux
ZIP/Postal Code
69200
Country
France
Facility Name
Research Site
City
Bad Krozingen
ZIP/Postal Code
79189
Country
Germany
Facility Name
Research Site
City
Berlin (Hellersdorf)
ZIP/Postal Code
12627
Country
Germany
Facility Name
Research Site
City
Berlin
ZIP/Postal Code
10787
Country
Germany
Facility Name
Research Site
City
Berlin
ZIP/Postal Code
13353
Country
Germany
Facility Name
Research Site
City
Dresden
ZIP/Postal Code
01307
Country
Germany
Facility Name
Research Site
City
Heppenheim
ZIP/Postal Code
64646
Country
Germany
Facility Name
Research Site
City
Homburg
ZIP/Postal Code
66421
Country
Germany
Facility Name
Research Site
City
Köln
ZIP/Postal Code
50937
Country
Germany
Facility Name
Research Site
City
Leipzig
ZIP/Postal Code
04103
Country
Germany
Facility Name
Research Site
City
Magdeburg
ZIP/Postal Code
39112
Country
Germany
Facility Name
Research Site
City
Messkirch
ZIP/Postal Code
88605
Country
Germany
Facility Name
Research Site
City
München
ZIP/Postal Code
80638
Country
Germany
Facility Name
Research Site
City
Witten
ZIP/Postal Code
58455
Country
Germany
Facility Name
Research Site
City
Hong Kong
Country
Hong Kong
Facility Name
Research Site
City
New Territories
Country
Hong Kong
Facility Name
Research Site
City
Baja
ZIP/Postal Code
6500
Country
Hungary
Facility Name
Research Site
City
Berettyoujfalu
ZIP/Postal Code
4100
Country
Hungary
Facility Name
Research Site
City
Budapest
ZIP/Postal Code
1085
Country
Hungary
Facility Name
Research Site
City
Eger
ZIP/Postal Code
3300
Country
Hungary
Facility Name
Research Site
City
Gyongyos
ZIP/Postal Code
3200
Country
Hungary
Facility Name
Research Site
City
Hodmezovasarhely
ZIP/Postal Code
6800
Country
Hungary
Facility Name
Research Site
City
Jaszbereny
ZIP/Postal Code
5100
Country
Hungary
Facility Name
Research Site
City
Komarom
ZIP/Postal Code
2921
Country
Hungary
Facility Name
Research Site
City
Mosonmagyarovar
ZIP/Postal Code
9200
Country
Hungary
Facility Name
Research Site
City
Pecs
ZIP/Postal Code
7624
Country
Hungary
Facility Name
Research Site
City
Szeged
ZIP/Postal Code
6720
Country
Hungary
Facility Name
Research Site
City
Bologna
ZIP/Postal Code
40138
Country
Italy
Facility Name
Research Site
City
Cagliari
ZIP/Postal Code
09134
Country
Italy
Facility Name
Research Site
City
Chieti
ZIP/Postal Code
66100
Country
Italy
Facility Name
Research Site
City
Cinisello Balsamo (MI)
ZIP/Postal Code
20092
Country
Italy
Facility Name
Research Site
City
Ferrara
ZIP/Postal Code
44124
Country
Italy
Facility Name
Research Site
City
Milano
ZIP/Postal Code
20162
Country
Italy
Facility Name
Research Site
City
Napoli
ZIP/Postal Code
80131
Country
Italy
Facility Name
Research Site
City
Padova
ZIP/Postal Code
35128
Country
Italy
Facility Name
Research Site
City
Perugia
ZIP/Postal Code
06129
Country
Italy
Facility Name
Research Site
City
Pisa
ZIP/Postal Code
56100
Country
Italy
Facility Name
Research Site
City
Pisa
ZIP/Postal Code
56124
Country
Italy
Facility Name
Research Site
City
Trieste
ZIP/Postal Code
34149
Country
Italy
Facility Name
Research Site
City
Noda-shi
State/Province
Chiba
ZIP/Postal Code
278-0004
Country
Japan
Facility Name
Research Site
City
Fukuoka-shi
State/Province
Fukuoka
ZIP/Postal Code
810-0014
Country
Japan
Facility Name
Research Site
City
Fukuoka-shi
State/Province
Fukuoka
ZIP/Postal Code
810-0066
Country
Japan
Facility Name
Research Site
City
Fukuoka-shi
State/Province
Fukuoka
ZIP/Postal Code
819-8551
Country
Japan
Facility Name
Research Site
City
Kitakyusyu-shi
State/Province
Fukuoka
ZIP/Postal Code
807-0856
Country
Japan
Facility Name
Research Site
City
Koriyama-shi
State/Province
Fukushima
ZIP/Postal Code
963-0209
Country
Japan
Facility Name
Research Site
City
Koriyama-shi
State/Province
Fukushima
ZIP/Postal Code
963-8026
Country
Japan
Facility Name
Research Site
City
Koriyama-shi
State/Province
Fukushima
ZIP/Postal Code
963-8041
Country
Japan
Facility Name
Research Site
City
Koriyama-shi
State/Province
Fukushima
ZIP/Postal Code
963-8832
Country
Japan
Facility Name
Research Site
City
Koriyama-shi
State/Province
Fukushima
ZIP/Postal Code
963-8862
Country
Japan
Facility Name
Research Site
City
Maebashi-shi
State/Province
Gunma
ZIP/Postal Code
371-0022
Country
Japan
Facility Name
Research Site
City
Takasaki-shi
State/Province
Gunma
ZIP/Postal Code
370-3524
Country
Japan
Facility Name
Research Site
City
Sapporo-shi
State/Province
Hokkaido
ZIP/Postal Code
003-0026
Country
Japan
Facility Name
Research Site
City
Sapporo-shi
State/Province
Hokkaido
ZIP/Postal Code
003-0825
Country
Japan
Facility Name
Research Site
City
Sapporo-shi
State/Province
Hokkaido
ZIP/Postal Code
060-0063
Country
Japan
Facility Name
Research Site
City
Tsuchiura-shi
State/Province
Ibaraki
ZIP/Postal Code
300-0047
Country
Japan
Facility Name
Research Site
City
Morioka-shi
State/Province
Iwate
ZIP/Postal Code
020-0066
Country
Japan
Facility Name
Research Site
City
Takamatsu-shi
State/Province
Kagawa
ZIP/Postal Code
760-0018
Country
Japan
Facility Name
Research Site
City
Takamatsu-shi
State/Province
Kagawa
ZIP/Postal Code
760-0076
Country
Japan
Facility Name
Research Site
City
Yokohama-shi
State/Province
Kanagawa
ZIP/Postal Code
231-0023
Country
Japan
Facility Name
Research Site
City
Kyoto-shi
State/Province
Kyoto
ZIP/Postal Code
615-8125
Country
Japan
Facility Name
Research Site
City
Sendai-shi
State/Province
Miyagi
ZIP/Postal Code
983-0039
Country
Japan
Facility Name
Research Site
City
Sendai-shi
State/Province
Miyagi
ZIP/Postal Code
983-0835
Country
Japan
Facility Name
Research Site
City
Sendai-shi
State/Province
Miyagi
ZIP/Postal Code
989-3122
Country
Japan
Facility Name
Research Site
City
Tomigusuku-shi
State/Province
Okinawa
ZIP/Postal Code
901-0243
Country
Japan
Facility Name
Research Site
City
Ibaraki-shi
State/Province
Osaka
ZIP/Postal Code
567-0876
Country
Japan
Facility Name
Research Site
City
Toyonaka-shi
State/Province
Osaka
ZIP/Postal Code
560-0082
Country
Japan
Facility Name
Research Site
City
Koshigaya-shi
State/Province
Saitama
ZIP/Postal Code
343-0828
Country
Japan
Facility Name
Research Site
City
Niiza-shi
State/Province
Saitama
ZIP/Postal Code
352-0014
Country
Japan
Facility Name
Research Site
City
Arakawa-ku
State/Province
Tokyo
ZIP/Postal Code
116-0002
Country
Japan
Facility Name
Research Site
City
Chiyoda-ku
State/Province
Tokyo
ZIP/Postal Code
101-0041
Country
Japan
Facility Name
Research Site
City
Chofu-shi
State/Province
Tokyo
ZIP/Postal Code
182-0006
Country
Japan
Facility Name
Research Site
City
Edogawa-ku
State/Province
Tokyo
ZIP/Postal Code
133-0061
Country
Japan
Facility Name
Research Site
City
Hachioji-shi
State/Province
Tokyo
ZIP/Postal Code
192-0046
Country
Japan
Facility Name
Research Site
City
Katsushika-ku
State/Province
Tokyo
ZIP/Postal Code
124-0024
Country
Japan
Facility Name
Research Site
City
Koto-ku
State/Province
Tokyo
ZIP/Postal Code
135-0011
Country
Japan
Facility Name
Research Site
City
Minato-ku
State/Province
Tokyo
ZIP/Postal Code
105-7390
Country
Japan
Facility Name
Research Site
City
Minato-ku
State/Province
Tokyo
ZIP/Postal Code
108-0075
Country
Japan
Facility Name
Research Site
City
Ota-ku
State/Province
Tokyo
ZIP/Postal Code
144-0034
Country
Japan
Facility Name
Research Site
City
Setagaya-ku
State/Province
Tokyo
ZIP/Postal Code
155-0031
Country
Japan
Facility Name
Research Site
City
Shibuya-ku
State/Province
Tokyo
ZIP/Postal Code
150-0012
Country
Japan
Facility Name
Research Site
City
Shinagawa-ku
State/Province
Tokyo
ZIP/Postal Code
140-0011
Country
Japan
Facility Name
Research Site
City
Shinagawa-ku
State/Province
Tokyo
ZIP/Postal Code
141-0001
Country
Japan
Facility Name
Research Site
City
Shinagawa-ku
State/Province
Tokyo
ZIP/Postal Code
141-6003
Country
Japan
Facility Name
Research Site
City
Shinagawa-ku
State/Province
Tokyo
ZIP/Postal Code
142-0053
Country
Japan
Facility Name
Research Site
City
Toshima-ku
State/Province
Tokyo
ZIP/Postal Code
171-0021
Country
Japan
Facility Name
Research Site
City
Seoul
ZIP/Postal Code
120-752
Country
Korea, Republic of
Facility Name
Research Site
City
Seoul
ZIP/Postal Code
135-710
Country
Korea, Republic of
Facility Name
Research Site
City
Amsterdam
ZIP/Postal Code
1105 AZ
Country
Netherlands
Facility Name
Research Site
City
Den Helder
ZIP/Postal Code
1782 GZ
Country
Netherlands
Facility Name
Research Site
City
Groningen
ZIP/Postal Code
9713 GZ
Country
Netherlands
Facility Name
Research Site
City
Groningen
ZIP/Postal Code
9728 NT
Country
Netherlands
Facility Name
Research Site
City
Hoogeveen
ZIP/Postal Code
7909 AA
Country
Netherlands
Facility Name
Research Site
City
Hoorn
ZIP/Postal Code
1625 HV
Country
Netherlands
Facility Name
Research Site
City
Nijmegen
ZIP/Postal Code
6525 EZ
Country
Netherlands
Facility Name
Research Site
City
Rotterdam
ZIP/Postal Code
3045 PM
Country
Netherlands
Facility Name
Research Site
City
Tilburg
ZIP/Postal Code
5022 GC
Country
Netherlands
Facility Name
Research Site
City
Utrecht
ZIP/Postal Code
3584 CX
Country
Netherlands
Facility Name
Research Site
City
Waalwijk
ZIP/Postal Code
5141 BM
Country
Netherlands
Facility Name
Research Site
City
Zwijndrecht
ZIP/Postal Code
3331 LZ
Country
Netherlands
Facility Name
Research Site
City
Christchurch
ZIP/Postal Code
8011
Country
New Zealand
Facility Name
Research Site
City
Oslo
ZIP/Postal Code
0373
Country
Norway
Facility Name
Research Site
City
Ålesund
ZIP/Postal Code
6003
Country
Norway
Facility Name
Research Site
City
Lodz
ZIP/Postal Code
91-078
Country
Poland
Facility Name
Research Site
City
Barnaul
ZIP/Postal Code
656055
Country
Russian Federation
Facility Name
Research Site
City
Kemerovo
ZIP/Postal Code
650002
Country
Russian Federation
Facility Name
Research Site
City
Moscow
ZIP/Postal Code
121552
Country
Russian Federation
Facility Name
Research Site
City
Novosibirsk
ZIP/Postal Code
630047
Country
Russian Federation
Facility Name
Research Site
City
Saint Petersburg
ZIP/Postal Code
197022
Country
Russian Federation
Facility Name
Research Site
City
Saratov
ZIP/Postal Code
410054
Country
Russian Federation
Facility Name
Research Site
City
Centurion
State/Province
Gauteng
ZIP/Postal Code
0157
Country
South Africa
Facility Name
Research Site
City
Johannesburg
State/Province
Gauteng
ZIP/Postal Code
2193
Country
South Africa
Facility Name
Research Site
City
Midrand
State/Province
Gauteng
ZIP/Postal Code
1685
Country
South Africa
Facility Name
Research Site
City
Sunninghill
State/Province
Gauteng
ZIP/Postal Code
2157
Country
South Africa
Facility Name
Research Site
City
Amanzimtoti
State/Province
KwaZulu-Natal
ZIP/Postal Code
4126
Country
South Africa
Facility Name
Research Site
City
Observatory
State/Province
Western Cape
ZIP/Postal Code
7925
Country
South Africa
Facility Name
Research Site
City
Paarl
State/Province
Western Cape
ZIP/Postal Code
7646
Country
South Africa
Facility Name
Research Site
City
Parow
State/Province
Western Cape
ZIP/Postal Code
7505
Country
South Africa
Facility Name
Research Site
City
Somerset West
State/Province
Western Cape
ZIP/Postal Code
7130
Country
South Africa
Facility Name
Research Site
City
Bloemfontein
ZIP/Postal Code
9301
Country
South Africa
Facility Name
Research Site
City
Cordoba
State/Province
Andalucía
ZIP/Postal Code
14004
Country
Spain
Facility Name
Research Site
City
Zaragoza
State/Province
Aragón
ZIP/Postal Code
50009
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
Reus
State/Province
Cataluña
ZIP/Postal Code
43204
Country
Spain
Facility Name
Research Site
City
Madrid
ZIP/Postal Code
28007
Country
Spain
Facility Name
Research Site
City
Madrid
ZIP/Postal Code
28029
Country
Spain
Facility Name
Research Site
City
Madrid
ZIP/Postal Code
28040
Country
Spain
Facility Name
Research Site
City
Göteborg
ZIP/Postal Code
413 45
Country
Sweden
Facility Name
Research Site
City
Lund
ZIP/Postal Code
222 21
Country
Sweden
Facility Name
Research Site
City
Stockholm
ZIP/Postal Code
111 57
Country
Sweden
Facility Name
Research Site
City
Stockholm
ZIP/Postal Code
141 86
Country
Sweden
Facility Name
Research Site
City
Stockholm
ZIP/Postal Code
171 45
Country
Sweden
Facility Name
Research Site
City
Uddevalla
ZIP/Postal Code
451 50
Country
Sweden
Facility Name
Research Site
City
Örebro
ZIP/Postal Code
701 46
Country
Sweden
Facility Name
Research Site
City
Bellinzona
ZIP/Postal Code
6500
Country
Switzerland
Facility Name
Research Site
City
Geneva 14
ZIP/Postal Code
1211
Country
Switzerland
Facility Name
Research Site
City
Lausanne
ZIP/Postal Code
1011
Country
Switzerland
Facility Name
Research Site
City
Lugano
ZIP/Postal Code
6900
Country
Switzerland
Facility Name
Research Site
City
Muensterlingen
ZIP/Postal Code
8596
Country
Switzerland
Facility Name
Research Site
City
Reinach
ZIP/Postal Code
4153
Country
Switzerland
Facility Name
Research Site
City
St. Gallen
ZIP/Postal Code
9007
Country
Switzerland
Facility Name
Research Site
City
Zurich
ZIP/Postal Code
8063
Country
Switzerland
Facility Name
Research Site
City
Zurich
ZIP/Postal Code
8091
Country
Switzerland
Facility Name
Research Site
City
Kaohsiung
ZIP/Postal Code
83301
Country
Taiwan
Facility Name
Research Site
City
Taipei
ZIP/Postal Code
100
Country
Taiwan
Facility Name
Research Site
City
Birmingham
ZIP/Postal Code
B15 2SQ
Country
United Kingdom
Facility Name
Research Site
City
Birmingham
ZIP/Postal Code
B15 2TH
Country
United Kingdom
Facility Name
Research Site
City
Blackpool
ZIP/Postal Code
FY3 7EN
Country
United Kingdom
Facility Name
Research Site
City
Cardiff
ZIP/Postal Code
CF14 5GJ
Country
United Kingdom
Facility Name
Research Site
City
Chesterfield
ZIP/Postal Code
S40 4AA
Country
United Kingdom
Facility Name
Research Site
City
Chorley
ZIP/Postal Code
PR7 7NA
Country
United Kingdom
Facility Name
Research Site
City
Coventry
ZIP/Postal Code
CV2 2DX
Country
United Kingdom
Facility Name
Research Site
City
Doncaster
ZIP/Postal Code
DN9 1EP
Country
United Kingdom
Facility Name
Research Site
City
Glasgow
ZIP/Postal Code
G12 8TA
Country
United Kingdom
Facility Name
Research Site
City
Glasgow
ZIP/Postal Code
G20 0SP
Country
United Kingdom
Facility Name
Research Site
City
Glasgow
ZIP/Postal Code
G45 9AW
Country
United Kingdom
Facility Name
Research Site
City
Liverpool
ZIP/Postal Code
L22 0LG
Country
United Kingdom
Facility Name
Research Site
City
Liverpool
ZIP/Postal Code
L7 8XP
Country
United Kingdom
Facility Name
Research Site
City
London
ZIP/Postal Code
NW3 2QG
Country
United Kingdom
Facility Name
Research Site
City
London
ZIP/Postal Code
SE1 7EH
Country
United Kingdom
Facility Name
Research Site
City
London
ZIP/Postal Code
W6 8RF
Country
United Kingdom
Facility Name
Research Site
City
Manchester
ZIP/Postal Code
M13 9WL
Country
United Kingdom
Facility Name
Research Site
City
Manchester
ZIP/Postal Code
M15 6SX
Country
United Kingdom
Facility Name
Research Site
City
Newcastle upon Tyne
ZIP/Postal Code
NE1 4LP
Country
United Kingdom
Facility Name
Research Site
City
Reading
ZIP/Postal Code
RG2 0TG
Country
United Kingdom
Facility Name
Research Site
City
Telford
ZIP/Postal Code
TF1 6TF
Country
United Kingdom
Facility Name
Research Site
City
Wakefield
ZIP/Postal Code
WF1 4DG
Country
United Kingdom
Facility Name
Research Site
City
West Bromwich
ZIP/Postal Code
B71 4HJ
Country
United Kingdom
Facility Name
Research Site
City
Whitby
ZIP/Postal Code
YO21 1SD
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
29353350
Citation
Kasichayanula S, Grover A, Emery MG, Gibbs MA, Somaratne R, Wasserman SM, Gibbs JP. Clinical Pharmacokinetics and Pharmacodynamics of Evolocumab, a PCSK9 Inhibitor. Clin Pharmacokinet. 2018 Jul;57(7):769-779. doi: 10.1007/s40262-017-0620-7.
Results Reference
background
PubMed Identifier
28844508
Citation
Sattar N, Toth PP, Blom DJ, Koren MJ, Soran H, Uhart M, Elliott M, Cyrille M, Somaratne R, Preiss D. Effect of the Proprotein Convertase Subtilisin/Kexin Type 9 Inhibitor Evolocumab on Glycemia, Body Weight, and New-Onset Diabetes Mellitus. Am J Cardiol. 2017 Nov 1;120(9):1521-1527. doi: 10.1016/j.amjcard.2017.07.047. Epub 2017 Jul 31.
Results Reference
result
PubMed Identifier
29066265
Citation
Hovingh GK, Raal FJ, Dent R, Stefanutti C, Descamps O, Masana L, Lira A, Bridges I, Coll B, Sullivan D. Long-term safety, tolerability, and efficacy of evolocumab in patients with heterozygous familial hypercholesterolemia. J Clin Lipidol. 2017 Nov-Dec;11(6):1448-1457. doi: 10.1016/j.jacl.2017.09.003. Epub 2017 Sep 22.
Results Reference
result
PubMed Identifier
33078867
Citation
Schmidt AF, Carter JL, Pearce LS, Wilkins JT, Overington JP, Hingorani AD, Casas JP. PCSK9 monoclonal antibodies for the primary and secondary prevention of cardiovascular disease. Cochrane Database Syst Rev. 2020 Oct 20;10(10):CD011748. doi: 10.1002/14651858.CD011748.pub3.
Results Reference
derived
PubMed Identifier
25773607
Citation
Sabatine MS, Giugliano RP, Wiviott SD, Raal FJ, Blom DJ, Robinson J, Ballantyne CM, Somaratne R, Legg J, Wasserman SM, Scott R, Koren MJ, Stein EA; Open-Label Study of Long-Term Evaluation against LDL Cholesterol (OSLER) Investigators. Efficacy and safety of evolocumab in reducing lipids and cardiovascular events. N Engl J Med. 2015 Apr 16;372(16):1500-9. doi: 10.1056/NEJMoa1500858. Epub 2015 Mar 15.
Results Reference
derived
Links:
URL
http://www.amgentrials.com
Description
AmgenTrials clinical trials website

Learn more about this trial

Open-label Extension Study of Evolocumab (AMG 145) in Adults With Hyperlipidemia and Mixed Dyslipidemia

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