Durable Effect of PCSK9 Antibody CompARed wiTh placEbo Study

Part of paid clinical trials in Birmingham, Alabama.

Sponsor
Amgen
Study ID
NCT01516879
Phase
PHASE3
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 80 Years
Healthy Volunteers
Not accepted

Interventions

  • Evolocumab — BIOLOGICAL
    Administered by subcutaneous injection once a month
  • Placebo — BIOLOGICAL
    Administered by subcutaneous injection once a month
  • Atorvastatin — DRUG
    Background lipid lowering therapy: 10 mg or 80 mg atorvastatin orally once daily.
  • Ezetimibe — DRUG
    Background lipid lowering therapy: ezetimibe 10 mg orally once a day
  • Diet Only — OTHER
    Diet only, no lipid lowering background drug given

Study Details

To evaluate the efficacy, safety, and tolerability of 52 weeks of subcutaneous (SC) evolocumab (AMG 145) compared with placebo when added to assigned background lipid-lowering therapy.

Key Dates

Start date
Jan 5, 2012
Status verified
Jul 2022
Primary completion
Oct 14, 2013
Completion
Oct 14, 2013

Study Design

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

Arms

  • Experimental: Evolocumab
    Participants received evolocumab 420 mg subcutaneously once a month for 52 weeks in addition to background lipid-lowering therapy.
  • Placebo Comparator: Placebo
    Participants received placebo subcutaneously once a month for 52 weeks in addition to background lipid-lowering therapy.

Primary Outcome Measure

Percent Change From Baseline in LDL-C at Week 52 [ Time Frame: Baseline and Week 52 ]

Locations (41)

FacilityCityStateZIPSite coordinators
Research SiteBirminghamAlabama35216-
Research SiteLittle RockArkansas72205-
Research SiteAnaheimCalifornia92801-
Research SiteEncinitasCalifornia92024-
Research SiteSpring ValleyCalifornia91978-
Research SiteWestlake VillageCalifornia91361-
Research SiteDeLandFlorida32720-
Research SiteJacksonvilleFlorida32204-
Research SiteJacksonvilleFlorida32216-
Research SitePonte VedraFlorida32081-
Research SiteAtlantaGeorgia30338-
Research SiteAtlantaGeorgia30342-
Research SiteSavannahGeorgia31406-
Research SiteChicagoIllinois60610-
Research SiteIndianapolisIndiana46260-
Research SiteLouisvilleKentucky40213-
Research SiteAuburnMaine04210-
Research SiteBethesdaMaryland20817-
Research SiteChevy ChaseMaryland20815-
Research SiteColumbiaMaryland21045-
Research SiteBrocktonMassachusetts02301-
Research SiteSaint PaulMinnesota55114-
Research SiteOlive BranchMississippi38654-
Research SiteLas VegasNevada89148-
Research SiteEndwellNew York13760-
Research SiteNew WindsorNew York12553-
Research SiteRaleighNorth Carolina27609-
Research SiteRaleighNorth Carolina27612-
Research SiteFargoNorth Dakota58103-
Research SiteAkronOhio44311-
Research SiteCincinnatiOhio45219-
Research SiteCincinnatiOhio45227-
Research SiteCincinnatiOhio45246-
Research SiteNormanOklahoma73069-
Research SiteDuncansvillePennsylvania16635-
Research SiteMt. PleasantSouth Carolina29464-
Research SiteRapid CitySouth Dakota57702-
Research SiteHoustonTexas77030-
Research SiteRichmondVirginia23294-
Research SiteRentonWashington98057-
Research SiteSeattleWashington98104-

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