Dyslipidemia Clinical Trial
— FOURIER OLEOfficial title:
A Multicenter, Open-label, Single-arm, Extension Study to Assess Long-term Safety of Evolocumab Therapy in Patients With Clinically Evident Cardiovascular Disease
| Verified date | March 2023 |
| Source | Amgen |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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).
| Status | Completed |
| Enrollment | 5035 |
| Est. completion date | March 21, 2022 |
| Est. primary completion date | March 21, 2022 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 40 Years to 85 Years |
| Eligibility | 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 |
| Country | Name | City | State |
|---|---|---|---|
| Czechia | Research Site | Brno | |
| Czechia | Research Site | Brno | |
| Czechia | Research Site | Brno | |
| Czechia | Research Site | Jihlava | |
| Czechia | Research Site | Liberec | |
| Czechia | Research Site | Mohelnice | |
| Czechia | Research Site | Ostrava | |
| Czechia | Research Site | Ostrava-Dubina | |
| Czechia | Research Site | Praha 2 | |
| Czechia | Research Site | Prerov | |
| Czechia | Research Site | Pribram VIII | |
| Czechia | Research Site | Znojmo | |
| Hungary | Research Site | Bekescsaba | |
| Hungary | Research Site | Miskolc | |
| Hungary | Research Site | Nyiregyhaza | |
| Poland | Research Site | Bielsko-Biala | |
| Poland | Research Site | Bydgoszcz | |
| Poland | Research Site | Gdansk | |
| Poland | Research Site | Gdynia | |
| Poland | Research Site | Gdynia | |
| Poland | Research Site | Gizycko | |
| Poland | Research Site | Katowice | |
| Poland | Research Site | Kielce | |
| Poland | Research Site | Krakow | |
| Poland | Research Site | Krakow | |
| Poland | Research Site | Krakow | |
| Poland | Research Site | Lodz | |
| Poland | Research Site | Lublin | |
| Poland | Research Site | Nysa | |
| Poland | Research Site | Olsztyn | |
| Poland | Research Site | Plock | |
| Poland | Research Site | Poznan | |
| Poland | Research Site | Pszczyna | |
| Poland | Research Site | Pulawy | |
| Poland | Research Site | Ruda Slaska | |
| Poland | Research Site | Skierniewice | |
| Poland | Research Site | Staszow | |
| Poland | Research Site | Swidnik | |
| Poland | Research Site | Tarnow | |
| Poland | Research Site | Torun | |
| Poland | Research Site | Warszawa | |
| Poland | Research Site | Warszawa | |
| Poland | Research Site | Warszawa | |
| Poland | Research Site | Wloclawek | |
| Poland | Research Site | Wroclaw | |
| Poland | Research Site | Zamosc | |
| Russian Federation | Research Site | Moscow | |
| Russian Federation | Research Site | Saint-Petersburg | |
| Russian Federation | Research Site | Saint-Petersburg | |
| Russian Federation | Research Site | Saint-Petersburg | |
| Russian Federation | Research Site | Saratov | |
| Slovakia | Research Site | Kosice | |
| Slovakia | Research Site | Svidnik | |
| Ukraine | Research Site | Zaporizhzhya | |
| United States | Research Site | Addison | Illinois |
| United States | Research Site | Athens | Georgia |
| United States | Research Site | Atlanta | Georgia |
| United States | Research Site | Auburn | Maine |
| United States | Research Site | Augusta | Georgia |
| United States | Research Site | Aurora | Colorado |
| United States | Research Site | Austin | Texas |
| United States | Research Site | Baltimore | Maryland |
| United States | Research Site | Bangor | Maine |
| United States | Research Site | Banning | California |
| United States | Research Site | Belleville | Illinois |
| United States | Research Site | Biddeford | Maine |
| United States | Research Site | Birmingham | Alabama |
| United States | Research Site | Boynton Beach | Florida |
| United States | Research Site | Brooklyn | New York |
| United States | Research Site | Burke | Virginia |
| United States | Research Site | Calabash | North Carolina |
| United States | Research Site | Camp Hill | Pennsylvania |
| United States | Research Site | Canton | Ohio |
| United States | Research Site | Chambersburg | Pennsylvania |
| United States | Research Site | Charleston | South Carolina |
| United States | Research Site | Charlotte | North Carolina |
| United States | Research Site | Chicago | Illinois |
| United States | Research Site | Cincinnati | Ohio |
| United States | Research Site | Clearwater | Florida |
| United States | Research Site | Coeur d'Alene | Idaho |
| United States | Research Site | Colorado Springs | Colorado |
| United States | Research Site | Columbia | Maryland |
| United States | Research Site | Columbus | Ohio |
| United States | Research Site | Columbus | Ohio |
| United States | Research Site | Cortlandt Manor | New York |
| United States | Research Site | Crystal River | Florida |
| United States | Research Site | Dayton | Ohio |
| United States | Research Site | Daytona Beach | Florida |
| United States | Research Site | Denver | Colorado |
| United States | Research Site | Dunwoody | Georgia |
| United States | Research Site | Elyria | Ohio |
| United States | Research Site | Evansville | Indiana |
| United States | Research Site | Falls Church | Virginia |
| United States | Research Site | Fargo | North Dakota |
| United States | Research Site | Federal Way | Washington |
| United States | Research Site | Gainesville | Georgia |
| United States | Research Site | Germantown | Tennessee |
| United States | Research Site | Grandville | Michigan |
| United States | Research Site | Green Bay | Wisconsin |
| United States | Research Site | Greensboro | North Carolina |
| United States | Research Site | Hammond | Louisiana |
| United States | Research Site | Haverhill | Massachusetts |
| United States | Research Site | Hickory | North Carolina |
| United States | Research Site | High Point | North Carolina |
| United States | Research Site | Hollywood | Florida |
| United States | Research Site | Hollywood | Florida |
| United States | Research Site | Houston | Texas |
| United States | Research Site | Houston | Texas |
| United States | Research Site | Huntsville | Alabama |
| United States | Research Site | Indian Land | South Carolina |
| United States | Research Site | Iowa City | Iowa |
| United States | Research Site | Jacksonville | Florida |
| United States | Research Site | Jerseyville | Illinois |
| United States | Research Site | Kalispell | Montana |
| United States | Research Site | Kansas City | Missouri |
| United States | Research Site | Kansas City | Kansas |
| United States | Research Site | Kerrville | Texas |
| United States | Research Site | Lansing | Michigan |
| United States | Research Site | Largo | Florida |
| United States | Research Site | Las Vegas | Nevada |
| United States | Research Site | Layton | Utah |
| United States | Research Site | Lexington | Kentucky |
| United States | Research Site | Lincoln | Nebraska |
| United States | Research Site | Littleton | Colorado |
| United States | Research Site | Long Beach | California |
| United States | Research Site | Marion | Ohio |
| United States | Research Site | Memphis | Tennessee |
| United States | Research Site | Meridian | Idaho |
| United States | Research Site | Metairie | Louisiana |
| United States | Research Site | Miami | Florida |
| United States | Research Site | Moncks Corner | South Carolina |
| United States | Research Site | Monroe | Louisiana |
| United States | Research Site | Mooresville | North Carolina |
| United States | Research Site | Munster | Indiana |
| United States | Research Site | Muskegon | Michigan |
| United States | Research Site | Nashville | Tennessee |
| United States | Research Site | Natchitoches | Louisiana |
| United States | Research Site | New Hyde Park | New York |
| United States | Research Site | New Port Richey | Florida |
| United States | Research Site | New Windsor | New York |
| United States | Research Site | New York | New York |
| United States | Research Site | Newton | Massachusetts |
| United States | Research Site | North Myrtle Beach | South Carolina |
| United States | Research Site | Oceanside | California |
| United States | Research Site | Oxnard | California |
| United States | Research Site | Palm Springs | California |
| United States | Research Site | Pawtucket | Rhode Island |
| United States | Research Site | Pensacola | Florida |
| United States | Research Site | Philadelphia | Pennsylvania |
| United States | Research Site | Phoenix | Arizona |
| United States | Research Site | Pittsburgh | Pennsylvania |
| United States | Research Site | Plano | Texas |
| United States | Research Site | Plano | Texas |
| United States | Research Site | Ponte Vedra Beach | Florida |
| United States | Research Site | Port Charlotte | Florida |
| United States | Research Site | Portland | Oregon |
| United States | Research Site | Pryor | Oklahoma |
| United States | Research Site | Rapid City | South Dakota |
| United States | Research Site | Richmond | Virginia |
| United States | Research Site | Rochester | New York |
| United States | Research Site | Roseville | California |
| United States | Research Site | Saginaw | Michigan |
| United States | Research Site | Saint Cloud | Minnesota |
| United States | Research Site | Saint Louis | Missouri |
| United States | Research Site | Saint Paul | Minnesota |
| United States | Research Site | Saint Petersburg | Florida |
| United States | Research Site | Salisbury | Maryland |
| United States | Research Site | San Antonio | Texas |
| United States | Research Site | San Diego | California |
| United States | Research Site | San Pedro | California |
| United States | Research Site | Sandusky | Ohio |
| United States | Research Site | Sarasota | Florida |
| United States | Research Site | Sarasota | Florida |
| United States | Research Site | Savannah | Georgia |
| United States | Research Site | Seattle | Washington |
| United States | Research Site | Slidell | Louisiana |
| United States | Research Site | Springfield | Ohio |
| United States | Research Site | Statesville | North Carolina |
| United States | Research Site | Suffolk | Virginia |
| United States | Research Site | Suwanee | Georgia |
| United States | Research Site | Tabor City | North Carolina |
| United States | Research Site | Tarzana | California |
| United States | Research Site | Toledo | Ohio |
| United States | Research Site | Torrance | California |
| United States | Research Site | Tullahoma | Tennessee |
| United States | Research Site | Tulsa | Oklahoma |
| United States | Research Site | Tupelo | Mississippi |
| United States | Research Site | Valley Village | California |
| United States | Research Site | Voorhees | New Jersey |
| United States | Research Site | Waterloo | Iowa |
| United States | Research Site | West Jordan | Utah |
| United States | Research Site | West Seneca | New York |
| United States | Research Site | Wichita | Kansas |
| United States | Research Site | Wichita Falls | Texas |
| United States | Research Site | Williamsville | New York |
| United States | Research Site | Willoughby | Ohio |
| United States | Research Site | Wilmington | North Carolina |
| United States | Research Site | Winston-Salem | North Carolina |
| Lead Sponsor | Collaborator |
|---|---|
| Amgen |
United States, Czechia, Hungary, Poland, Russian Federation, Slovakia, Ukraine,
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 Feb 13. doi: 10.1161/CIRCULATIONAHA.122.063399. Online ahead of print. — View 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. — View Citation
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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. | Up to 5 years | |
| Secondary | Percent Change of Low-density Lipoprotein Cholesterol (LDL-C) From Baseline at Each Scheduled Visit | Week 12, Week 24, Week 48, Week 72, Week 96, Week 120, Week 144, Week 168, Week 192, Week 216, Week 260 | ||
| Secondary | Percentage of Participants Who Achieved an LDL-C Level < 40 mg/dL | Week 12, Week 24, Week 48, Week 72, Week 96, Week 120, Week 144, Week 168, Week 192, Week 216, Week 260 |
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