Further Cardiovascular Outcomes Research With PCSK9 Inhibition in Subjects With Elevated Risk Open-label Extension

Part of paid clinical trials in Birmingham, Alabama.

Sponsor
Amgen
Study ID
NCT02867813
Phase
PHASE3
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
40 Years - 85 Years
Healthy Volunteers
Not accepted

Interventions

  • Evolocumab — BIOLOGICAL
    subjects will receive evolocumab 140 mg every 2 weeks (Q2W) or 420 mg monthly (QM), according to the subject's preference.

Study Details

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).

Key Dates

Start date
Sep 2, 2016
Status verified
Mar 2023
Primary completion
Mar 21, 2022
Completion
Mar 21, 2022

Study Design

Enrollment
5,035 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • 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.

Primary Outcome Measure

Number of Participants Who Experienced an Adverse Event [ Time Frame: Up to 5 years ]

Locations (144)

FacilityCityStateZIPSite coordinators
Research SiteBirminghamAlabama35294-
Research SiteHuntsvilleAlabama35801-
Research SitePhoenixArizona85018-
Research SiteBanningCalifornia92220-
Research SiteLong BeachCalifornia90807-
Research SiteOceansideCalifornia92056-
Research SiteOxnardCalifornia93030-
Research SitePalm SpringsCalifornia92262-
Research SiteRosevilleCalifornia95661-
Research SiteSan DiegoCalifornia92161-
Research SiteSan PedroCalifornia90732-
Research SiteTarzanaCalifornia91356-
Research SiteTorranceCalifornia90502-
Research SiteValley VillageCalifornia91607-
Research SiteAuroraColorado80012-
Research SiteColorado SpringsColorado80909-
Research SiteDenverColorado80218-
Research SiteLittletonColorado80120-
Research SiteBoynton BeachFlorida33472-
Research SiteClearwaterFlorida33756-
Research SiteCrystal RiverFlorida34429-
Research SiteDaytona BeachFlorida32117-
Research SiteHollywoodFlorida33021-
Research SiteHollywoodFlorida33024-
Research SiteJacksonvilleFlorida32216-
Research SiteLargoFlorida33777-
Research SiteMiamiFlorida33173-
Research SiteNew Port RicheyFlorida34653-
Research SitePensacolaFlorida32501-
Research SitePonte Vedra BeachFlorida32081-
Research SitePort CharlotteFlorida33952-
Research SiteSarasotaFlorida34232-
Research SiteSarasotaFlorida34239-
Research SiteSt. PetersburgFlorida33713-
Research SiteAthensGeorgia30606-
Research SiteAtlantaGeorgia30342-
Research SiteAugustaGeorgia30909-
Research SiteDunwoodyGeorgia30338-
Research SiteGainesvilleGeorgia30501-
Research SiteSavannahGeorgia31406-
Research SiteSuwaneeGeorgia30024-
Research SiteCoeur d'AleneIdaho83814-
Research SiteMeridianIdaho83642-
Research SiteAddisonIllinois60101-
Research SiteBellevilleIllinois62220-
Research SiteChicagoIllinois60616-
Research SiteJerseyvilleIllinois62052-
Research SiteEvansvilleIndiana47714-
Research SiteMunsterIndiana46321-
Research SiteIowa CityIowa52242-
Research SiteWaterlooIowa50702-
Research SiteKansas CityKansas66160-
Research SiteWichitaKansas67203-
Research SiteLexingtonKentucky40503-
Research SiteHammondLouisiana70403-
Research SiteMetairieLouisiana70006-
Research SiteMonroeLouisiana71201-
Research SiteNatchitochesLouisiana71457-
Research SiteSlidellLouisiana70458-
Research SiteAuburnMaine04210-
Research SiteBangorMaine04401-
Research SiteBiddefordMaine04005-
Research SiteBaltimoreMaryland21204-
Research SiteColumbiaMaryland21044-
Research SiteSalisburyMaryland21804-
Research SiteHaverhillMassachusetts01830-
Research SiteNewtonMassachusetts02459-
Research SiteGrandvilleMichigan49418-
Research SiteLansingMichigan48912-
Research SiteMuskegonMichigan49444-
Research SiteSaginawMichigan48601-
Research SiteSaint CloudMinnesota56303-
Research SiteSaint PaulMinnesota55102-
Research SiteTupeloMississippi38801-
Research SiteKansas CityMissouri64128-
Research SiteSt LouisMissouri63128-
Research SiteKalispellMontana59901-
Research SiteLincolnNebraska68506-
Research SiteLas VegasNevada89148-
Research SiteVoorhees TownshipNew Jersey08043-
Research SiteBrooklynNew York11206-
Research SiteCortlandt ManorNew York10567-
Research SiteNew Hyde ParkNew York11042-
Research SiteNew WindsorNew York12553-
Research SiteNew YorkNew York10029-
Research SiteRochesterNew York14609-
Research SiteWest SenecaNew York14224-
Research SiteWilliamsvilleNew York14221-
Research SiteCalabashNorth Carolina28467-
Research SiteCharlotteNorth Carolina28204-
Research SiteGreensboroNorth Carolina27408-
Research SiteHickoryNorth Carolina28601-
Research SiteHigh PointNorth Carolina27262-
Research SiteMooresvilleNorth Carolina28117-
Research SiteStatesvilleNorth Carolina28625-
Research SiteTabor CityNorth Carolina28463-
Research SiteWilmingtonNorth Carolina28401-
Research SiteWinston-SalemNorth Carolina27103-
Research SiteFargoNorth Dakota58122-
Research SiteCantonOhio44710-
Research SiteCincinnatiOhio45219-
Research SiteColumbusOhio43201-
Research SiteColumbusOhio43215-
Research SiteDaytonOhio45414-
Research SiteElyriaOhio44035-
Research SiteMarionOhio43302-
Research SiteSanduskyOhio44870-
Research SiteSpringfieldOhio45505-
Research SiteToledoOhio43615-
Research SiteWilloughbyOhio44094-
Research SitePryorOklahoma74361-
Research SiteTulsaOklahoma74133-
Research SitePortlandOregon97225-
Research SiteCamp HillPennsylvania17011-
Research SiteChambersburgPennsylvania17201-
Research SitePhiladelphiaPennsylvania19152-
Research SitePittsburghPennsylvania15206-
Research SitePawtucketRhode Island02860-
Research SiteCharlestonSouth Carolina29407-
Research SiteMoncks CornerSouth Carolina29461-
Research SiteNorth Myrtle BeachSouth Carolina29582-
Research SiteOld Point StationSouth Carolina29707-
Research SiteRapid CitySouth Dakota57701-
Research SiteGermantownTennessee38138-
Research SiteMemphisTennessee38104-
Research SiteNashvilleTennessee37203-
Research SiteTullahomaTennessee37388-
Research SiteAustinTexas78758-
Research SiteHoustonTexas77025-
Research SiteHoustonTexas77030-
Research SiteKerrvilleTexas78028-
Research SitePlanoTexas75023-
Research SitePlanoTexas75024-
Research SiteSan AntonioTexas78229-
Research SiteWichita FallsTexas76301-
Research SiteLaytonUtah84041-
Research SiteWest JordanUtah84088-
Research SiteBurkeVirginia22015-
Research SiteFalls ChurchVirginia22042-
Research SiteRichmondVirginia23294-
Research SiteSuffolkVirginia23435-
Research SiteFederal WayWashington98003-
Research SiteSeattleWashington98195-
Research SiteGreen BayWisconsin54301-

Find similar trials in Birmingham, AL

By research site
Research Site· Birmingham, ALResearch Site· Huntsville, ALResearch Site· Phoenix, AZResearch Site· Banning, CAResearch Site· Long Beach, CAResearch Site· Oceanside, CA

Related Studies