FOURIER OLE: Further Cardiovascular Outcomes Research With PCSK9 Inhibition in Subjects With Elevated Risk Open-label Extension
Sponsor
Amgen (Industry)
Overall Status
Completed
CT.gov ID
NCT02867813
Collaborator
(none)
5,037
198
1
66.7
25.4
0.4
Study Details
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).
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 3 |
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.
Study Design
Study Type:
Interventional
Actual Enrollment
:
5037 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
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
Actual Study Start Date
:
Sep 2, 2016
Actual Primary Completion Date
:
Mar 24, 2022
Actual Study Completion Date
:
Mar 24, 2022
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: evolocumab (AMG 145) 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. |
Biological: Evolocumab
subjects will receive evolocumab 140 mg every 2 weeks (Q2W) or 420 mg monthly (QM), according to the subject's preference.
|
Outcome Measures
Primary Outcome Measures
- Subject incidence of adverse events [5 years]
Secondary Outcome Measures
- Percent change of LDL-C from baseline at each scheduled visit [5 years]
- Achieve an LDL-C < 40 mg/dL (1.03 mmol/L) at each scheduled visit [5 years]
Eligibility Criteria
Criteria
Ages Eligible for Study:
40 Years
to 85 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Research Site | Birmingham | Alabama | United States | 35294 |
| 2 | Research Site | Huntsville | Alabama | United States | 35801 |
| 3 | Research Site | Phoenix | Arizona | United States | 85018 |
| 4 | Research Site | Banning | California | United States | 92220 |
| 5 | Research Site | Long Beach | California | United States | 90807 |
| 6 | Research Site | Oceanside | California | United States | 92056 |
| 7 | Research Site | Oxnard | California | United States | 93030 |
| 8 | Research Site | Palm Springs | California | United States | 92262 |
| 9 | Research Site | Roseville | California | United States | 95661 |
| 10 | Research Site | San Diego | California | United States | 92161 |
| 11 | Research Site | San Pedro | California | United States | 90732 |
| 12 | Research Site | Tarzana | California | United States | 91356 |
| 13 | Research Site | Torrance | California | United States | 90502 |
| 14 | Research Site | Valley Village | California | United States | 91607 |
| 15 | Research Site | Aurora | Colorado | United States | 80012 |
| 16 | Research Site | Colorado Springs | Colorado | United States | 80909 |
| 17 | Research Site | Denver | Colorado | United States | 80218 |
| 18 | Research Site | Littleton | Colorado | United States | 80120 |
| 19 | Research Site | Boynton Beach | Florida | United States | 33472 |
| 20 | Research Site | Clearwater | Florida | United States | 33756 |
| 21 | Research Site | Crystal River | Florida | United States | 34429 |
| 22 | Research Site | Daytona Beach | Florida | United States | 32117 |
| 23 | Research Site | Hollywood | Florida | United States | 33021 |
| 24 | Research Site | Hollywood | Florida | United States | 33024 |
| 25 | Research Site | Jacksonville | Florida | United States | 32216 |
| 26 | Research Site | Largo | Florida | United States | 33777 |
| 27 | Research Site | Miami | Florida | United States | 33173 |
| 28 | Research Site | New Port Richey | Florida | United States | 34653 |
| 29 | Research Site | Pensacola | Florida | United States | 32501 |
| 30 | Research Site | Ponte Vedra Beach | Florida | United States | 32081 |
| 31 | Research Site | Port Charlotte | Florida | United States | 33952 |
| 32 | Research Site | Saint Petersburg | Florida | United States | 33713 |
| 33 | Research Site | Sarasota | Florida | United States | 34232 |
| 34 | Research Site | Sarasota | Florida | United States | 34239 |
| 35 | Research Site | Athens | Georgia | United States | 30606 |
| 36 | Research Site | Atlanta | Georgia | United States | 30342 |
| 37 | Research Site | Augusta | Georgia | United States | 30909 |
| 38 | Research Site | Dunwoody | Georgia | United States | 30338 |
| 39 | Research Site | Gainesville | Georgia | United States | 30501 |
| 40 | Research Site | Savannah | Georgia | United States | 31406 |
| 41 | Research Site | Suwanee | Georgia | United States | 30024 |
| 42 | Research Site | Coeur d'Alene | Idaho | United States | 83814 |
| 43 | Research Site | Meridian | Idaho | United States | 83642 |
| 44 | Research Site | Addison | Illinois | United States | 60101 |
| 45 | Research Site | Belleville | Illinois | United States | 62220 |
| 46 | Research Site | Chicago | Illinois | United States | 60616 |
| 47 | Research Site | Jerseyville | Illinois | United States | 62052 |
| 48 | Research Site | Evansville | Indiana | United States | 47714 |
| 49 | Research Site | Munster | Indiana | United States | 46321 |
| 50 | Research Site | Iowa City | Iowa | United States | 52242 |
| 51 | Research Site | Waterloo | Iowa | United States | 50702 |
| 52 | Research Site | Kansas City | Kansas | United States | 66160 |
| 53 | Research Site | Wichita | Kansas | United States | 67203 |
| 54 | Research Site | Lexington | Kentucky | United States | 40503 |
| 55 | Research Site | Hammond | Louisiana | United States | 70403 |
| 56 | Research Site | Metairie | Louisiana | United States | 70006 |
| 57 | Research Site | Monroe | Louisiana | United States | 71201 |
| 58 | Research Site | Natchitoches | Louisiana | United States | 71457 |
| 59 | Research Site | Slidell | Louisiana | United States | 70458 |
| 60 | Research Site | Auburn | Maine | United States | 04210 |
| 61 | Research Site | Bangor | Maine | United States | 04401 |
| 62 | Research Site | Biddeford | Maine | United States | 04005 |
| 63 | Research Site | Baltimore | Maryland | United States | 21204 |
| 64 | Research Site | Columbia | Maryland | United States | 21044 |
| 65 | Research Site | Salisbury | Maryland | United States | 21804 |
| 66 | Research Site | Haverhill | Massachusetts | United States | 01830 |
| 67 | Research Site | Newton | Massachusetts | United States | 02459 |
| 68 | Research Site | Grandville | Michigan | United States | 49418 |
| 69 | Research Site | Lansing | Michigan | United States | 48912 |
| 70 | Research Site | Muskegon | Michigan | United States | 49444 |
| 71 | Research Site | Saginaw | Michigan | United States | 48601 |
| 72 | Research Site | Saint Cloud | Minnesota | United States | 56303 |
| 73 | Research Site | Saint Paul | Minnesota | United States | 55102 |
| 74 | Research Site | Tupelo | Mississippi | United States | 38801 |
| 75 | Research Site | Kansas City | Missouri | United States | 64128 |
| 76 | Research Site | Saint Louis | Missouri | United States | 63128 |
| 77 | Research Site | Kalispell | Montana | United States | 59901 |
| 78 | Research Site | Lincoln | Nebraska | United States | 68506 |
| 79 | Research Site | Las Vegas | Nevada | United States | 89148 |
| 80 | Research Site | Voorhees | New Jersey | United States | 08043 |
| 81 | Research Site | Brooklyn | New York | United States | 11206 |
| 82 | Research Site | Cortlandt Manor | New York | United States | 10567 |
| 83 | Research Site | New Hyde Park | New York | United States | 11042 |
| 84 | Research Site | New Windsor | New York | United States | 12553 |
| 85 | Research Site | New York | New York | United States | 10029 |
| 86 | Research Site | Rochester | New York | United States | 14609 |
| 87 | Research Site | West Seneca | New York | United States | 14224 |
| 88 | Research Site | Williamsville | New York | United States | 14221 |
| 89 | Research Site | Calabash | North Carolina | United States | 28467 |
| 90 | Research Site | Charlotte | North Carolina | United States | 28204 |
| 91 | Research Site | Greensboro | North Carolina | United States | 27408 |
| 92 | Research Site | Hickory | North Carolina | United States | 28601 |
| 93 | Research Site | High Point | North Carolina | United States | 27262 |
| 94 | Research Site | Mooresville | North Carolina | United States | 28117 |
| 95 | Research Site | Statesville | North Carolina | United States | 28625 |
| 96 | Research Site | Tabor City | North Carolina | United States | 28463 |
| 97 | Research Site | Wilmington | North Carolina | United States | 28401 |
| 98 | Research Site | Winston-Salem | North Carolina | United States | 27103 |
| 99 | Research Site | Fargo | North Dakota | United States | 58122 |
| 100 | Research Site | Canton | Ohio | United States | 44710 |
| 101 | Research Site | Cincinnati | Ohio | United States | 45219 |
| 102 | Research Site | Columbus | Ohio | United States | 43201 |
| 103 | Research Site | Columbus | Ohio | United States | 43215 |
| 104 | Research Site | Dayton | Ohio | United States | 45414 |
| 105 | Research Site | Elyria | Ohio | United States | 44035 |
| 106 | Research Site | Marion | Ohio | United States | 43302 |
| 107 | Research Site | Sandusky | Ohio | United States | 44870 |
| 108 | Research Site | Springfield | Ohio | United States | 45505 |
| 109 | Research Site | Toledo | Ohio | United States | 43615 |
| 110 | Research Site | Willoughby | Ohio | United States | 44094 |
| 111 | Research Site | Pryor | Oklahoma | United States | 74361 |
| 112 | Research Site | Tulsa | Oklahoma | United States | 74133 |
| 113 | Research Site | Portland | Oregon | United States | 97225 |
| 114 | Research Site | Camp Hill | Pennsylvania | United States | 17011 |
| 115 | Research Site | Chambersburg | Pennsylvania | United States | 17201 |
| 116 | Research Site | Philadelphia | Pennsylvania | United States | 19152 |
| 117 | Research Site | Pittsburgh | Pennsylvania | United States | 15206 |
| 118 | Research Site | Pawtucket | Rhode Island | United States | 02860 |
| 119 | Research Site | Charleston | South Carolina | United States | 29407 |
| 120 | Research Site | Indian Land | South Carolina | United States | 29707 |
| 121 | Research Site | Moncks Corner | South Carolina | United States | 29461 |
| 122 | Research Site | North Myrtle Beach | South Carolina | United States | 29582 |
| 123 | Research Site | Rapid City | South Dakota | United States | 57701 |
| 124 | Research Site | Germantown | Tennessee | United States | 38138 |
| 125 | Research Site | Memphis | Tennessee | United States | 38104 |
| 126 | Research Site | Nashville | Tennessee | United States | 37203 |
| 127 | Research Site | Tullahoma | Tennessee | United States | 37388 |
| 128 | Research Site | Austin | Texas | United States | 78758 |
| 129 | Research Site | Houston | Texas | United States | 77025 |
| 130 | Research Site | Houston | Texas | United States | 77030 |
| 131 | Research Site | Kerrville | Texas | United States | 78028 |
| 132 | Research Site | Plano | Texas | United States | 75023 |
| 133 | Research Site | Plano | Texas | United States | 75024 |
| 134 | Research Site | San Antonio | Texas | United States | 78229 |
| 135 | Research Site | Wichita Falls | Texas | United States | 76301 |
| 136 | Research Site | Layton | Utah | United States | 84041 |
| 137 | Research Site | West Jordan | Utah | United States | 84088 |
| 138 | Research Site | Burke | Virginia | United States | 22015 |
| 139 | Research Site | Falls Church | Virginia | United States | 22042 |
| 140 | Research Site | Richmond | Virginia | United States | 23294 |
| 141 | Research Site | Suffolk | Virginia | United States | 23435 |
| 142 | Research Site | Federal Way | Washington | United States | 98003 |
| 143 | Research Site | Seattle | Washington | United States | 98195 |
| 144 | Research Site | Green Bay | Wisconsin | United States | 54301 |
| 145 | Research Site | Brno | Czechia | 603 00 | |
| 146 | Research Site | Brno | Czechia | 625 00 | |
| 147 | Research Site | Brno | Czechia | 638 00 | |
| 148 | Research Site | Jihlava | Czechia | 586 33 | |
| 149 | Research Site | Liberec | Czechia | 460 63 | |
| 150 | Research Site | Mohelnice | Czechia | 789 85 | |
| 151 | Research Site | Ostrava-Dubina | Czechia | 700 30 | |
| 152 | Research Site | Ostrava | Czechia | 728 80 | |
| 153 | Research Site | Praha 2 | Czechia | 128 08 | |
| 154 | Research Site | Prerov | Czechia | 750 02 | |
| 155 | Research Site | Pribram VIII | Czechia | 261 01 | |
| 156 | Research Site | Znojmo | Czechia | 669 02 | |
| 157 | Research Site | Bekescsaba | Hungary | 5600 | |
| 158 | Research Site | Miskolc | Hungary | 3529 | |
| 159 | Research Site | Nyiregyhaza | Hungary | 4400 | |
| 160 | Research Site | Bielsko-Biala | Poland | 43-316 | |
| 161 | Research Site | Bydgoszcz | Poland | 85-094 | |
| 162 | Research Site | Gdansk | Poland | 80-542 | |
| 163 | Research Site | Gdynia | Poland | 81-402 | |
| 164 | Research Site | Gdynia | Poland | 81-472 | |
| 165 | Research Site | Gizycko | Poland | 11-500 | |
| 166 | Research Site | Katowice | Poland | 40-084 | |
| 167 | Research Site | Kielce | Poland | 25-020 | |
| 168 | Research Site | Krakow | Poland | 30-082 | |
| 169 | Research Site | Krakow | Poland | 31-202 | |
| 170 | Research Site | Krakow | Poland | 31-216 | |
| 171 | Research Site | Lodz | Poland | 91-347 | |
| 172 | Research Site | Lublin | Poland | 20-857 | |
| 173 | Research Site | Nysa | Poland | 48-300 | |
| 174 | Research Site | Olsztyn | Poland | 10-010 | |
| 175 | Research Site | Plock | Poland | 09-402 | |
| 176 | Research Site | Poznan | Poland | 61-853 | |
| 177 | Research Site | Pszczyna | Poland | 43-200 | |
| 178 | Research Site | Pulawy | Poland | 24-100 | |
| 179 | Research Site | Ruda Slaska | Poland | 41-709 | |
| 180 | Research Site | Skierniewice | Poland | 96-100 | |
| 181 | Research Site | Staszow | Poland | 28-200 | |
| 182 | Research Site | Swidnik | Poland | 21-040 | |
| 183 | Research Site | Tarnow | Poland | 33-100 | |
| 184 | Research Site | Torun | Poland | 87-100 | |
| 185 | Research Site | Warszawa | Poland | 02-097 | |
| 186 | Research Site | Warszawa | Poland | 02-507 | |
| 187 | Research Site | Warszawa | Poland | 04-628 | |
| 188 | Research Site | Wloclawek | Poland | 87-800 | |
| 189 | Research Site | Wroclaw | Poland | 50-349 | |
| 190 | Research Site | Zamosc | Poland | 22-400 | |
| 191 | Research Site | Moscow | Russian Federation | 129090 | |
| 192 | Research Site | Saint-Petersburg | Russian Federation | 192289 | |
| 193 | Research Site | Saint-Petersburg | Russian Federation | 197022 | |
| 194 | Research Site | Saint-Petersburg | Russian Federation | 199106 | |
| 195 | Research Site | Saratov | Russian Federation | 410054 | |
| 196 | Research Site | Kosice | Slovakia | 040 22 | |
| 197 | Research Site | Svidnik | Slovakia | 089 01 | |
| 198 | Research Site | Zaporizhzhya | Ukraine | 69600 |
Sponsors and Collaborators
- Amgen
Investigators
- Study Director: MD, Amgen
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
None provided.Responsible Party:
Amgen
ClinicalTrials.gov Identifier:
NCT02867813
Other Study ID Numbers:
- 20130295
- 2015-004780-36
First Posted:
Aug 16, 2016
Last Update Posted:
Apr 5, 2022
Last Verified:
Apr 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Keywords provided by Amgen
Additional relevant MeSH terms: