Goal Achievement After Utilizing an Anti-PCSK9 Antibody in Statin Intolerant Subjects

Part of paid clinical trials in Anaheim, California.

Sponsor
Amgen
Study ID
NCT01375764
Phase
PHASE2
Status
Completed

Conditions

  • Hyperlipidemia

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • Evolocumab — BIOLOGICAL
    Administered by subcutaneous injection
  • Ezetimibe — DRUG
    Administered orally once a day
  • Placebo to Evolocumab — OTHER
    Administered by subcutaneous injection

Study Details

The primary objective was to evaluate the effect of 12 weeks of subcutaneous evolocumab (AMG 145), compared with ezetimibe, on percent change from baseline in low-density lipoprotein cholesterol (LDL-C) in patients with hypercholesterolemia unable to tolerate an effective dose of a statin.

Key Dates

Start date
Jul 28, 2011
Status verified
Nov 2022
Primary completion
May 8, 2012
Completion
May 8, 2012

Study Design

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

Arms

  • Active Comparator: Ezetimibe
    Participants received placebo subcutaneous injection once every 4 weeks and 10 mg ezetimibe orally once a day for 12 weeks.
  • Experimental: Evolocumab + Ezetimibe
    Participants received 420 mg evolocumab by subcutaneous injection once every 4 weeks and 10 mg ezetimibe orally once a day for 12 weeks.
  • Experimental: Evolocumab 280 mg
    Participants received 280 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.
  • Experimental: Evolocumab 350 mg
    Participants received 350 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.
  • Experimental: Evolocumab 420 mg
    Participants received 420 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.

Primary Outcome Measure

Percent Change From Baseline in Low-Density Lipoprotein Cholesterol (LDL-C) at Week 12 [ Time Frame: Baseline and Week 12 ]

Locations (16)

FacilityCityStateZIPSite coordinators
Research SiteAnaheimCalifornia92801-
Research SiteMission ViejoCalifornia92691-
Research SiteWestlake VillageCalifornia91361-
Research SiteAtlantaGeorgia30338-
Research SiteAtlantaGeorgia30342-
Research SiteSavannahGeorgia31406-
Research SiteAuburnMaine04210-
Research SiteChevy ChaseMaryland20815-
Research SiteButteMontana59701-
Research SiteHendersonNevada89052-
Research SiteLas VegasNevada89117-
Research SiteNew YorkNew York10029-
Research SiteRaleighNorth Carolina27609-
Research SiteAkronOhio44311-
Research SiteCincinnatiOhio45212-
Research SiteBristolTennessee37620-

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Research Site· Anaheim, CAResearch Site· Mission Viejo, CAResearch Site· Westlake Village, CAResearch Site· Atlanta, GAResearch Site· Savannah, GAResearch Site· Auburn, ME

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