Evaluation of Evolocumab (AMG 145) Efficacy in Diabetic Adults With Hypercholesterolemia/Mixed Dyslipidemia

Part of paid clinical trials in Tuscumbia, Alabama.

Sponsor
Amgen
Study ID
NCT02739984
Phase
PHASE3
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Evolocumab — BIOLOGICAL
    Administered by subcutaneous injection with an automated mini doser
  • Placebo to Evolocumab — DRUG
    Administered by subcutaneous injection with an automated mini doser

Study Details

The purpose of this study is to evaluate the effect of 12 weeks of subcutaneous evolocumab taken monthly compared with subcutaneous placebo taken monthly on low density lipoprotein cholesterol (LDL-C) in adults with type 2 diabetes mellitus and high blood cholesterol on a maximally tolerated oral dose of statin of at least moderate-intensity.

Key Dates

Start date
May 17, 2016
Status verified
Aug 2018
Primary completion
Aug 3, 2017
Completion
Aug 3, 2017

Study Design

Enrollment
424 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Placebo Comparator: Placebo
    Participants received placebo subcutaneous injection once every month (QM) for 12 weeks.
  • Experimental: Evolocumab
    Participants received 420 mg evolocumab subcutaneous injection once every month (QM) for 12 weeks.

Primary Outcome Measure

Percent Change From Baseline in LDL-C at the Mean of Weeks 10 and 12 [ Time Frame: Baseline and Weeks 10 and 12 ]

Locations (46)

FacilityCityStateZIPSite coordinators
Research SiteTuscumbiaAlabama35674-
Research SitePhoenixArizona85012-
Research SiteLomitaCalifornia90717-
Research SiteLos AngelesCalifornia90057-
Research SiteRosevilleCalifornia95661-
Research SiteSan RamonCalifornia94583-
Research SiteSpring ValleyCalifornia91978-
Research SiteTarzanaCalifornia91356-
Research SiteWalnut CreekCalifornia94598-
Research SiteDenverColorado80246-
Research SiteLakewoodColorado80227-
Research SiteWilmingtonDelaware19803-
Research SiteBoca RatonFlorida33434-
Research SiteCoral GablesFlorida33134-
Research SiteDaytona BeachFlorida32117-
Research SiteFleming IslandFlorida32003-
Research SiteHollywoodFlorida33021-
Research SiteInvernessFlorida34452-
Research SiteJacksonvilleFlorida32216-
Research SiteMiamiFlorida33135-
Research SiteMiamiFlorida33136-
Research SiteWest Palm BeachFlorida33401-
Research SiteDunwoodyGeorgia30338-
Research SiteMeridianIdaho83642-
Research SiteChicagoIllinois60611-
Research SiteChicagoIllinois60612-
Research SiteChicagoIllinois60616-
Research SiteLouisvilleKentucky40213-
Research SiteAuburnMaine04210-
Research SiteScarboroughMaine04074-
Research SiteSalisburyMaryland21804-
Research SiteMethuenMassachusetts01844-
Research SiteBay CityMichigan48706-
Research SiteTupeloMississippi38801-
Research SiteLas VegasNevada89148-
Research SiteAlbuquerqueNew Mexico87106-
Research SiteNew WindsorNew York12553-
Research SiteNew YorkNew York10016-
Research SiteNew YorkNew York10029-
Research SiteShelbyNorth Carolina28150-
Research SiteTabor CityNorth Carolina28463-
Research SiteColumbusOhio43203-
Research SiteNormanOklahoma73069-
Research SiteAustinTexas78749-
Research SiteHoustonTexas77070-
Research SiteSuffolkVirginia23435-

Find similar trials in Tuscumbia, AL

By condition
Type 2 diabetes
By specialty
EndocrinologyMetabolic healthWeight loss
By research site
Research Site· Tuscumbia, ALResearch Site· Phoenix, AZResearch Site· Lomita, CAResearch Site· Los Angeles, CAResearch Site· Roseville, CAResearch Site· San Ramon, CA

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