Back to resultsFurther Cardiovascular Outcomes Research With PCSK9 Inhibition in Subjects With Elevated Risk Open-label Extension (FOURIER OLE)
Primary Purpose
Dyslipidemia
Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Evolocumab
Sponsored by
About this trial
This is an interventional treatment trial for Dyslipidemia focused on measuring High Cholesterol, Treatment for high cholesterol, Lowering cholesterol, Lowering high cholesterol, Hypercholesterolemia
Eligibility Criteria
Inclusion Criteria:
- Subject has provided informed consent before initiation of any study-specific activities/procedures
- Subject has completed FOURIER (Study 20110118) while still receiving assigned investigational product.
Exclusion Criteria:
- Investigational product was permanently discontinued during FOURIER for any reason, including an adverse event or serious adverse event
- Subject is currently receiving treatment in another investigational device or drug study, or ended treatment on another investigational device or drug study(ies) within less than 4 weeks. Other investigational procedures while participating in this study are excluded
- Subject is not likely to be available to complete protocol-required study visits or procedures and/or to comply with required study procedures to the best of the subject's and investigator's knowledge
- Subject has a history or evidence of any other clinically significant disorder, condition, or disease that, in the opinion of the investigator or Amgen physician, if consulted, would pose a risk to subject safety or interfere with the study evaluation, procedures, or completion
- Subject has a known sensitivity to any of the active substances or excipients (eg, sodium acetate) to be administered during dosing
- Female subject is pregnant or breastfeeding or is planning to become pregnant or planning to breastfeed during treatment with evolocumab and within 15 weeks after the end of treatment with evolocumab
- Female subjects of childbearing potential who are not willing to use an acceptable method(s) of effective birth control during treatment with evolocumab and for an additional 15 weeks after the end of treatment with evolocumab are excluded
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Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
evolocumab (AMG 145)
Arm Description
All subjects are randomized to a single arm and will receive evolocumab 140mg every two weeks (Q2W) or 420mg monthly (QM) according to subject's preference.
Outcomes
Primary Outcome Measures
Number of Participants Who Experienced an Adverse Event
All adverse event summaries for the primary analysis of the primary endpoint (OLE study period only) included all treatment-emergent events reported on the Event electronic case report form (eCRF), including CEC positively reviewed events and disease-related events.
Secondary Outcome Measures
Percent Change of Low-density Lipoprotein Cholesterol (LDL-C) From Baseline at Each Scheduled Visit
Percentage of Participants Who Achieved an LDL-C Level < 40 mg/dL
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02867813
Brief Title
Further Cardiovascular Outcomes Research With PCSK9 Inhibition in Subjects With Elevated Risk Open-label Extension
Acronym
FOURIER OLE
Official Title
A Multicenter, Open-label, Single-arm, Extension Study to Assess Long-term Safety of Evolocumab Therapy in Patients With Clinically Evident Cardiovascular Disease
Study Type
Interventional
2. Study Status
Record Verification Date
March 2023
Overall Recruitment Status
Completed
Study Start Date
September 2, 2016 (Actual)
Primary Completion Date
March 21, 2022 (Actual)
Study Completion Date
March 21, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Amgen
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The primary clinical hypothesis is that long-term exposure of evolocumab will be safe and well tolerated in subjects with clinically evident atherosclerotic cardiovascular disease (CVD).
Detailed Description
This is a multicenter, open-label extension study designed to assess the long-term safety of evolocumab in subjects who completed the FOURIER study,which is a randomized placebo-controlled study of evolocumab in subjects with clinically evident atherosclerotic CVD on stable effective statin therapy. Eligible subjects at sites participating in FOURIER OLE who have signed the FOURIER OLE informed consent may be enrolled at the completion of FOURIER study.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dyslipidemia
Keywords
High Cholesterol, Treatment for high cholesterol, Lowering cholesterol, Lowering high cholesterol, 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
5035 (Actual)
8. Arms, Groups, and Interventions
Arm Title
evolocumab (AMG 145)
Arm Type
Experimental
Arm Description
All subjects are randomized to a single arm and will receive evolocumab 140mg every two weeks (Q2W) or 420mg monthly (QM) according to subject's preference.
Intervention Type
Biological
Intervention Name(s)
Evolocumab
Intervention Description
subjects will receive evolocumab 140 mg every 2 weeks (Q2W) or 420 mg monthly (QM), according to the subject's preference.
Primary Outcome Measure Information:
Title
Number of Participants Who Experienced an Adverse Event
Description
All adverse event summaries for the primary analysis of the primary endpoint (OLE study period only) included all treatment-emergent events reported on the Event electronic case report form (eCRF), including CEC positively reviewed events and disease-related events.
Time Frame
Up to 5 years
Secondary Outcome Measure Information:
Title
Percent Change of Low-density Lipoprotein Cholesterol (LDL-C) From Baseline at Each Scheduled Visit
Time Frame
Week 12, Week 24, Week 48, Week 72, Week 96, Week 120, Week 144, Week 168, Week 192, Week 216, Week 260
Title
Percentage of Participants Who Achieved an LDL-C Level < 40 mg/dL
Time Frame
Week 12, Week 24, Week 48, Week 72, Week 96, Week 120, Week 144, Week 168, Week 192, Week 216, Week 260
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Subject has provided informed consent before initiation of any study-specific activities/procedures
Subject has completed FOURIER (Study 20110118) while still receiving assigned investigational product.
Exclusion Criteria:
Investigational product was permanently discontinued during FOURIER for any reason, including an adverse event or serious adverse event
Subject is currently receiving treatment in another investigational device or drug study, or ended treatment on another investigational device or drug study(ies) within less than 4 weeks. Other investigational procedures while participating in this study are excluded
Subject is not likely to be available to complete protocol-required study visits or procedures and/or to comply with required study procedures to the best of the subject's and investigator's knowledge
Subject has a history or evidence of any other clinically significant disorder, condition, or disease that, in the opinion of the investigator or Amgen physician, if consulted, would pose a risk to subject safety or interfere with the study evaluation, procedures, or completion
Subject has a known sensitivity to any of the active substances or excipients (eg, sodium acetate) to be administered during dosing
Female subject is pregnant or breastfeeding or is planning to become pregnant or planning to breastfeed during treatment with evolocumab and within 15 weeks after the end of treatment with evolocumab
Female subjects of childbearing potential who are not willing to use an acceptable method(s) of effective birth control during treatment with evolocumab and for an additional 15 weeks after the end of treatment with evolocumab are excluded
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
35294
Country
United States
Facility Name
Research Site
City
Huntsville
State/Province
Alabama
ZIP/Postal Code
35801
Country
United States
Facility Name
Research Site
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85018
Country
United States
Facility Name
Research Site
City
Banning
State/Province
California
ZIP/Postal Code
92220
Country
United States
Facility Name
Research Site
City
Long Beach
State/Province
California
ZIP/Postal Code
90807
Country
United States
Facility Name
Research Site
City
Oceanside
State/Province
California
ZIP/Postal Code
92056
Country
United States
Facility Name
Research Site
City
Oxnard
State/Province
California
ZIP/Postal Code
93030
Country
United States
Facility Name
Research Site
City
Palm Springs
State/Province
California
ZIP/Postal Code
92262
Country
United States
Facility Name
Research Site
City
Roseville
State/Province
California
ZIP/Postal Code
95661
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
San Pedro
State/Province
California
ZIP/Postal Code
90732
Country
United States
Facility Name
Research Site
City
Tarzana
State/Province
California
ZIP/Postal Code
91356
Country
United States
Facility Name
Research Site
City
Torrance
State/Province
California
ZIP/Postal Code
90502
Country
United States
Facility Name
Research Site
City
Valley Village
State/Province
California
ZIP/Postal Code
91607
Country
United States
Facility Name
Research Site
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80012
Country
United States
Facility Name
Research Site
City
Colorado Springs
State/Province
Colorado
ZIP/Postal Code
80909
Country
United States
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Research Site
City
Denver
State/Province
Colorado
ZIP/Postal Code
80218
Country
United States
Facility Name
Research Site
City
Littleton
State/Province
Colorado
ZIP/Postal Code
80120
Country
United States
Facility Name
Research Site
City
Boynton Beach
State/Province
Florida
ZIP/Postal Code
33472
Country
United States
Facility Name
Research Site
City
Clearwater
State/Province
Florida
ZIP/Postal Code
33756
Country
United States
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Research Site
City
Crystal River
State/Province
Florida
ZIP/Postal Code
34429
Country
United States
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Research Site
City
Daytona Beach
State/Province
Florida
ZIP/Postal Code
32117
Country
United States
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Research Site
City
Hollywood
State/Province
Florida
ZIP/Postal Code
33021
Country
United States
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Research Site
City
Hollywood
State/Province
Florida
ZIP/Postal Code
33024
Country
United States
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Research Site
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32216
Country
United States
Facility Name
Research Site
City
Largo
State/Province
Florida
ZIP/Postal Code
33777
Country
United States
Facility Name
Research Site
City
Miami
State/Province
Florida
ZIP/Postal Code
33173
Country
United States
Facility Name
Research Site
City
New Port Richey
State/Province
Florida
ZIP/Postal Code
34653
Country
United States
Facility Name
Research Site
City
Pensacola
State/Province
Florida
ZIP/Postal Code
32501
Country
United States
Facility Name
Research Site
City
Ponte Vedra Beach
State/Province
Florida
ZIP/Postal Code
32081
Country
United States
Facility Name
Research Site
City
Port Charlotte
State/Province
Florida
ZIP/Postal Code
33952
Country
United States
Facility Name
Research Site
City
Saint Petersburg
State/Province
Florida
ZIP/Postal Code
33713
Country
United States
Facility Name
Research Site
City
Sarasota
State/Province
Florida
ZIP/Postal Code
34232
Country
United States
Facility Name
Research Site
City
Sarasota
State/Province
Florida
ZIP/Postal Code
34239
Country
United States
Facility Name
Research Site
City
Athens
State/Province
Georgia
ZIP/Postal Code
30606
Country
United States
Facility Name
Research Site
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30342
Country
United States
Facility Name
Research Site
City
Augusta
State/Province
Georgia
ZIP/Postal Code
30909
Country
United States
Facility Name
Research Site
City
Dunwoody
State/Province
Georgia
ZIP/Postal Code
30338
Country
United States
Facility Name
Research Site
City
Gainesville
State/Province
Georgia
ZIP/Postal Code
30501
Country
United States
Facility Name
Research Site
City
Savannah
State/Province
Georgia
ZIP/Postal Code
31406
Country
United States
Facility Name
Research Site
City
Suwanee
State/Province
Georgia
ZIP/Postal Code
30024
Country
United States
Facility Name
Research Site
City
Coeur d'Alene
State/Province
Idaho
ZIP/Postal Code
83814
Country
United States
Facility Name
Research Site
City
Meridian
State/Province
Idaho
ZIP/Postal Code
83642
Country
United States
Facility Name
Research Site
City
Addison
State/Province
Illinois
ZIP/Postal Code
60101
Country
United States
Facility Name
Research Site
City
Belleville
State/Province
Illinois
ZIP/Postal Code
62220
Country
United States
Facility Name
Research Site
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60616
Country
United States
Facility Name
Research Site
City
Jerseyville
State/Province
Illinois
ZIP/Postal Code
62052
Country
United States
Facility Name
Research Site
City
Evansville
State/Province
Indiana
ZIP/Postal Code
47714
Country
United States
Facility Name
Research Site
City
Munster
State/Province
Indiana
ZIP/Postal Code
46321
Country
United States
Facility Name
Research Site
City
Iowa City
State/Province
Iowa
ZIP/Postal Code
52242
Country
United States
Facility Name
Research Site
City
Waterloo
State/Province
Iowa
ZIP/Postal Code
50702
Country
United States
Facility Name
Research Site
City
Kansas City
State/Province
Kansas
ZIP/Postal Code
66160
Country
United States
Facility Name
Research Site
City
Wichita
State/Province
Kansas
ZIP/Postal Code
67203
Country
United States
Facility Name
Research Site
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40503
Country
United States
Facility Name
Research Site
City
Hammond
State/Province
Louisiana
ZIP/Postal Code
70403
Country
United States
Facility Name
Research Site
City
Metairie
State/Province
Louisiana
ZIP/Postal Code
70006
Country
United States
Facility Name
Research Site
City
Monroe
State/Province
Louisiana
ZIP/Postal Code
71201
Country
United States
Facility Name
Research Site
City
Natchitoches
State/Province
Louisiana
ZIP/Postal Code
71457
Country
United States
Facility Name
Research Site
City
Slidell
State/Province
Louisiana
ZIP/Postal Code
70458
Country
United States
Facility Name
Research Site
City
Auburn
State/Province
Maine
ZIP/Postal Code
04210
Country
United States
Facility Name
Research Site
City
Bangor
State/Province
Maine
ZIP/Postal Code
04401
Country
United States
Facility Name
Research Site
City
Biddeford
State/Province
Maine
ZIP/Postal Code
04005
Country
United States
Facility Name
Research Site
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21204
Country
United States
Facility Name
Research Site
City
Columbia
State/Province
Maryland
ZIP/Postal Code
21044
Country
United States
Facility Name
Research Site
City
Salisbury
State/Province
Maryland
ZIP/Postal Code
21804
Country
United States
Facility Name
Research Site
City
Haverhill
State/Province
Massachusetts
ZIP/Postal Code
01830
Country
United States
Facility Name
Research Site
City
Newton
State/Province
Massachusetts
ZIP/Postal Code
02459
Country
United States
Facility Name
Research Site
City
Grandville
State/Province
Michigan
ZIP/Postal Code
49418
Country
United States
Facility Name
Research Site
City
Lansing
State/Province
Michigan
ZIP/Postal Code
48912
Country
United States
Facility Name
Research Site
City
Muskegon
State/Province
Michigan
ZIP/Postal Code
49444
Country
United States
Facility Name
Research Site
City
Saginaw
State/Province
Michigan
ZIP/Postal Code
48601
Country
United States
Facility Name
Research Site
City
Saint Cloud
State/Province
Minnesota
ZIP/Postal Code
56303
Country
United States
Facility Name
Research Site
City
Saint Paul
State/Province
Minnesota
ZIP/Postal Code
55102
Country
United States
Facility Name
Research Site
City
Tupelo
State/Province
Mississippi
ZIP/Postal Code
38801
Country
United States
Facility Name
Research Site
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64128
Country
United States
Facility Name
Research Site
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63128
Country
United States
Facility Name
Research Site
City
Kalispell
State/Province
Montana
ZIP/Postal Code
59901
Country
United States
Facility Name
Research Site
City
Lincoln
State/Province
Nebraska
ZIP/Postal Code
68506
Country
United States
Facility Name
Research Site
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89148
Country
United States
Facility Name
Research Site
City
Voorhees
State/Province
New Jersey
ZIP/Postal Code
08043
Country
United States
Facility Name
Research Site
City
Brooklyn
State/Province
New York
ZIP/Postal Code
11206
Country
United States
Facility Name
Research Site
City
Cortlandt Manor
State/Province
New York
ZIP/Postal Code
10567
Country
United States
Facility Name
Research Site
City
New Hyde Park
State/Province
New York
ZIP/Postal Code
11042
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
West Seneca
State/Province
New York
ZIP/Postal Code
14224
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
Calabash
State/Province
North Carolina
ZIP/Postal Code
28467
Country
United States
Facility Name
Research Site
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28204
Country
United States
Facility Name
Research Site
City
Greensboro
State/Province
North Carolina
ZIP/Postal Code
27408
Country
United States
Facility Name
Research Site
City
Hickory
State/Province
North Carolina
ZIP/Postal Code
28601
Country
United States
Facility Name
Research Site
City
High Point
State/Province
North Carolina
ZIP/Postal Code
27262
Country
United States
Facility Name
Research Site
City
Mooresville
State/Province
North Carolina
ZIP/Postal Code
28117
Country
United States
Facility Name
Research Site
City
Statesville
State/Province
North Carolina
ZIP/Postal Code
28625
Country
United States
Facility Name
Research Site
City
Tabor City
State/Province
North Carolina
ZIP/Postal Code
28463
Country
United States
Facility Name
Research Site
City
Wilmington
State/Province
North Carolina
ZIP/Postal Code
28401
Country
United States
Facility Name
Research Site
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27103
Country
United States
Facility Name
Research Site
City
Fargo
State/Province
North Dakota
ZIP/Postal Code
58122
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
Columbus
State/Province
Ohio
ZIP/Postal Code
43201
Country
United States
Facility Name
Research Site
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43215
Country
United States
Facility Name
Research Site
City
Dayton
State/Province
Ohio
ZIP/Postal Code
45414
Country
United States
Facility Name
Research Site
City
Elyria
State/Province
Ohio
ZIP/Postal Code
44035
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
Springfield
State/Province
Ohio
ZIP/Postal Code
45505
Country
United States
Facility Name
Research Site
City
Toledo
State/Province
Ohio
ZIP/Postal Code
43615
Country
United States
Facility Name
Research Site
City
Willoughby
State/Province
Ohio
ZIP/Postal Code
44094
Country
United States
Facility Name
Research Site
City
Pryor
State/Province
Oklahoma
ZIP/Postal Code
74361
Country
United States
Facility Name
Research Site
City
Tulsa
State/Province
Oklahoma
ZIP/Postal Code
74133
Country
United States
Facility Name
Research Site
City
Portland
State/Province
Oregon
ZIP/Postal Code
97225
Country
United States
Facility Name
Research Site
City
Camp Hill
State/Province
Pennsylvania
ZIP/Postal Code
17011
Country
United States
Facility Name
Research Site
City
Chambersburg
State/Province
Pennsylvania
ZIP/Postal Code
17201
Country
United States
Facility Name
Research Site
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19152
Country
United States
Facility Name
Research Site
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15206
Country
United States
Facility Name
Research Site
City
Pawtucket
State/Province
Rhode Island
ZIP/Postal Code
02860
Country
United States
Facility Name
Research Site
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29407
Country
United States
Facility Name
Research Site
City
Indian Land
State/Province
South Carolina
ZIP/Postal Code
29707
Country
United States
Facility Name
Research Site
City
Moncks Corner
State/Province
South Carolina
ZIP/Postal Code
29461
Country
United States
Facility Name
Research Site
City
North Myrtle Beach
State/Province
South Carolina
ZIP/Postal Code
29582
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
Germantown
State/Province
Tennessee
ZIP/Postal Code
38138
Country
United States
Facility Name
Research Site
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38104
Country
United States
Facility Name
Research Site
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37203
Country
United States
Facility Name
Research Site
City
Tullahoma
State/Province
Tennessee
ZIP/Postal Code
37388
Country
United States
Facility Name
Research Site
City
Austin
State/Province
Texas
ZIP/Postal Code
78758
Country
United States
Facility Name
Research Site
City
Houston
State/Province
Texas
ZIP/Postal Code
77025
Country
United States
Facility Name
Research Site
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Research Site
City
Kerrville
State/Province
Texas
ZIP/Postal Code
78028
Country
United States
Facility Name
Research Site
City
Plano
State/Province
Texas
ZIP/Postal Code
75023
Country
United States
Facility Name
Research Site
City
Plano
State/Province
Texas
ZIP/Postal Code
75024
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
Wichita Falls
State/Province
Texas
ZIP/Postal Code
76301
Country
United States
Facility Name
Research Site
City
Layton
State/Province
Utah
ZIP/Postal Code
84041
Country
United States
Facility Name
Research Site
City
West Jordan
State/Province
Utah
ZIP/Postal Code
84088
Country
United States
Facility Name
Research Site
City
Burke
State/Province
Virginia
ZIP/Postal Code
22015
Country
United States
Facility Name
Research Site
City
Falls Church
State/Province
Virginia
ZIP/Postal Code
22042
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
Federal Way
State/Province
Washington
ZIP/Postal Code
98003
Country
United States
Facility Name
Research Site
City
Seattle
State/Province
Washington
ZIP/Postal Code
98195
Country
United States
Facility Name
Research Site
City
Green Bay
State/Province
Wisconsin
ZIP/Postal Code
54301
Country
United States
Facility Name
Research Site
City
Brno
ZIP/Postal Code
603 00
Country
Czechia
Facility Name
Research Site
City
Brno
ZIP/Postal Code
625 00
Country
Czechia
Facility Name
Research Site
City
Brno
ZIP/Postal Code
638 00
Country
Czechia
Facility Name
Research Site
City
Jihlava
ZIP/Postal Code
586 33
Country
Czechia
Facility Name
Research Site
City
Liberec
ZIP/Postal Code
460 63
Country
Czechia
Facility Name
Research Site
City
Mohelnice
ZIP/Postal Code
789 85
Country
Czechia
Facility Name
Research Site
City
Ostrava-Dubina
ZIP/Postal Code
700 30
Country
Czechia
Facility Name
Research Site
City
Ostrava
ZIP/Postal Code
728 80
Country
Czechia
Facility Name
Research Site
City
Praha 2
ZIP/Postal Code
128 08
Country
Czechia
Facility Name
Research Site
City
Prerov
ZIP/Postal Code
750 02
Country
Czechia
Facility Name
Research Site
City
Pribram VIII
ZIP/Postal Code
261 01
Country
Czechia
Facility Name
Research Site
City
Znojmo
ZIP/Postal Code
669 02
Country
Czechia
Facility Name
Research Site
City
Bekescsaba
ZIP/Postal Code
5600
Country
Hungary
Facility Name
Research Site
City
Miskolc
ZIP/Postal Code
3529
Country
Hungary
Facility Name
Research Site
City
Nyiregyhaza
ZIP/Postal Code
4400
Country
Hungary
Facility Name
Research Site
City
Bielsko-Biala
ZIP/Postal Code
43-316
Country
Poland
Facility Name
Research Site
City
Bydgoszcz
ZIP/Postal Code
85-094
Country
Poland
Facility Name
Research Site
City
Gdansk
ZIP/Postal Code
80-542
Country
Poland
Facility Name
Research Site
City
Gdynia
ZIP/Postal Code
81-402
Country
Poland
Facility Name
Research Site
City
Gdynia
ZIP/Postal Code
81-472
Country
Poland
Facility Name
Research Site
City
Gizycko
ZIP/Postal Code
11-500
Country
Poland
Facility Name
Research Site
City
Katowice
ZIP/Postal Code
40-084
Country
Poland
Facility Name
Research Site
City
Kielce
ZIP/Postal Code
25-020
Country
Poland
Facility Name
Research Site
City
Krakow
ZIP/Postal Code
30-082
Country
Poland
Facility Name
Research Site
City
Krakow
ZIP/Postal Code
31-202
Country
Poland
Facility Name
Research Site
City
Krakow
ZIP/Postal Code
31-216
Country
Poland
Facility Name
Research Site
City
Lodz
ZIP/Postal Code
91-347
Country
Poland
Facility Name
Research Site
City
Lublin
ZIP/Postal Code
20-857
Country
Poland
Facility Name
Research Site
City
Nysa
ZIP/Postal Code
48-300
Country
Poland
Facility Name
Research Site
City
Olsztyn
ZIP/Postal Code
10-010
Country
Poland
Facility Name
Research Site
City
Plock
ZIP/Postal Code
09-402
Country
Poland
Facility Name
Research Site
City
Poznan
ZIP/Postal Code
61-853
Country
Poland
Facility Name
Research Site
City
Pszczyna
ZIP/Postal Code
43-200
Country
Poland
Facility Name
Research Site
City
Pulawy
ZIP/Postal Code
24-100
Country
Poland
Facility Name
Research Site
City
Ruda Slaska
ZIP/Postal Code
41-709
Country
Poland
Facility Name
Research Site
City
Skierniewice
ZIP/Postal Code
96-100
Country
Poland
Facility Name
Research Site
City
Staszow
ZIP/Postal Code
28-200
Country
Poland
Facility Name
Research Site
City
Swidnik
ZIP/Postal Code
21-040
Country
Poland
Facility Name
Research Site
City
Tarnow
ZIP/Postal Code
33-100
Country
Poland
Facility Name
Research Site
City
Torun
ZIP/Postal Code
87-100
Country
Poland
Facility Name
Research Site
City
Warszawa
ZIP/Postal Code
02-097
Country
Poland
Facility Name
Research Site
City
Warszawa
ZIP/Postal Code
02-507
Country
Poland
Facility Name
Research Site
City
Warszawa
ZIP/Postal Code
04-628
Country
Poland
Facility Name
Research Site
City
Wloclawek
ZIP/Postal Code
87-800
Country
Poland
Facility Name
Research Site
City
Wroclaw
ZIP/Postal Code
50-349
Country
Poland
Facility Name
Research Site
City
Zamosc
ZIP/Postal Code
22-400
Country
Poland
Facility Name
Research Site
City
Moscow
ZIP/Postal Code
129090
Country
Russian Federation
Facility Name
Research Site
City
Saint-Petersburg
ZIP/Postal Code
192289
Country
Russian Federation
Facility Name
Research Site
City
Saint-Petersburg
ZIP/Postal Code
197022
Country
Russian Federation
Facility Name
Research Site
City
Saint-Petersburg
ZIP/Postal Code
199106
Country
Russian Federation
Facility Name
Research Site
City
Saratov
ZIP/Postal Code
410054
Country
Russian Federation
Facility Name
Research Site
City
Kosice
ZIP/Postal Code
040 22
Country
Slovakia
Facility Name
Research Site
City
Svidnik
ZIP/Postal Code
089 01
Country
Slovakia
Facility Name
Research Site
City
Zaporizhzhya
ZIP/Postal Code
69600
Country
Ukraine
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request
IPD Sharing Time Frame
Data sharing requests relating to this study will be considered beginning 18 months after the study has ended and either 1) the product and indication (or other new use) have been granted marketing authorization in both the US and Europe or 2) clinical development for the product and/or indication discontinues and the data will not be submitted to regulatory authorities. There is no end date for eligibility to submit a data sharing request for this study.
IPD Sharing Access Criteria
Qualified researchers may submit a request containing the research objectives, the Amgen product(s) and Amgen study/studies in scope, endpoints/outcomes of interest, statistical analysis plan, data requirements, publication plan, and qualifications of the researcher(s). In general, Amgen does not grant external requests for individual patient data for the purpose of re-evaluating safety and efficacy issues already addressed in the product labelling. Requests are reviewed by a committee of internal advisors, and if not approved, may be further arbitrated by a Data Sharing Independent Review Panel. Upon approval, information necessary to address the research question will be provided under the terms of a data sharing agreement. This may include anonymized individual patient data and/or available supporting documents, containing fragments of analysis code where provided in analysis specifications. Further details are available at the link below.
IPD Sharing URL
https://www.amgen.com/datasharing
Citations:
PubMed Identifier
36031810
Citation
O'Donoghue ML, Giugliano RP, Wiviott SD, Atar D, Keech A, Kuder JF, Im K, Murphy SA, Flores-Arredondo JH, Lopez JAG, Elliott-Davey M, Wang B, Monsalvo ML, Abbasi S, Sabatine MS. Long-Term Evolocumab in Patients With Established Atherosclerotic Cardiovascular Disease. Circulation. 2022 Oct 11;146(15):1109-1119. doi: 10.1161/CIRCULATIONAHA.122.061620. Epub 2022 Aug 29.
Results Reference
background
PubMed Identifier
36779348
Citation
Gaba P, O'Donoghue ML, Park JG, Wiviott SD, Atar D, Kuder JF, Im K, Murphy SA, De Ferrari GM, Gaciong ZA, Toth K, Gouni-Berthold I, Lopez-Miranda J, Schiele F, Mach F, Flores-Arredondo JH, Lopez JAG, Elliott-Davey M, Wang B, Monsalvo ML, Abbasi S, Giugliano RP, Sabatine MS. Association Between Achieved Low-Density Lipoprotein Cholesterol Levels and Long-Term Cardiovascular and Safety Outcomes: An Analysis of FOURIER-OLE. Circulation. 2023 Apr 18;147(16):1192-1203. doi: 10.1161/CIRCULATIONAHA.122.063399. Epub 2023 Feb 13.
Results Reference
background
Links:
URL
http://www.amgentrials.com
Description
AmgenTrials clinical trials website
Learn more about this trial
Further Cardiovascular Outcomes Research With PCSK9 Inhibition in Subjects With Elevated Risk Open-label Extension
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