Goal Achievement After Utilizing an Anti-PCSK9 Antibody in Statin Intolerant Subjects -2

Part of paid clinical trials in Carmichael, California.

Sponsor
Amgen
Study ID
NCT01763905
Phase
PHASE3
Status
Completed

Conditions

  • Hyperlipidemia

Eligibility Criteria

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

Interventions

  • Evolocumab — BIOLOGICAL
    Subcutaneous injection
  • Placebo to Evolocumab — DRUG
    Subcutaneous injection
  • Ezetimibe — DRUG
    Tablet for oral administration
  • Placebo to Ezetimibe — DRUG
    Tablet for oral administration

Study Details

The primary objective was to evaluate the effect of 12 weeks of subcutaneous (SC) evolocumab every 2 weeks (Q2W) and monthly (QM), compared with ezetimibe, on percent change from baseline in low-density lipoprotein cholesterol (LDL-C) in hypercholesterolemic adults unable to tolerate an effective dose of a statin (HMG-CoA (5-hydroxy-3-methylglutaryl-coenzyme A) reductase inhibitors).

Key Dates

Start date
Jan 24, 2013
Status verified
Jul 2020
Primary completion
Nov 19, 2013
Completion
Nov 19, 2013

Study Design

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

Arms

  • Active Comparator: Ezetimibe (Q2W)
    Participants received placebo subcutaneous injection once every 2 weeks and 10 mg ezetimibe orally once a day for up to 12 weeks.
  • Active Comparator: Ezetimibe (QM)
    Participants received placebo subcutaneous injection once a month and 10 mg ezetimibe orally once a day for up to 12 weeks.
  • Experimental: Evolocumab Q2W
    Participants received 140 mg evolocumab by subcutaneous injection once every 2 weeks and placebo tablets once a day for up to 12 weeks.
  • Experimental: Evolocumab QM
    Participants received 420 mg evolocumab by subcutaneous injection once a month and placebo tablets once a day for up to 12 weeks.

Primary Outcome Measure

Percent Change From Baseline in LDL-C at Week 12 [ Time Frame: Baseline and Week 12 ]

Locations (20)

FacilityCityStateZIPSite coordinators
Research SiteCarmichaelCalifornia95608-
Research SiteLos AngelesCalifornia90048-
Research SiteMission ViejoCalifornia92691-
Research SiteThousand OaksCalifornia91360-
Research SiteAtlantaGeorgia30338-
Research SiteAtlantaGeorgia30342-
Research SiteSavannahGeorgia31406-
Research SiteAuburnMaine04210-
Research SiteTraverse CityMichigan49684-
Research SiteSt LouisMissouri63110-
Research SiteHendersonNevada89052-
Research SiteLas VegasNevada89117-
Research SiteLas VegasNevada89148-
Research SiteNew YorkNew York10029-
Research SiteRaleighNorth Carolina27609-
Research SiteAkronOhio44311-
Research SiteCincinnatiOhio45212-
Research SiteClevelandOhio44195-
Research SiteNormanOklahoma73069-
Research SiteHoustonTexas77030-

Find similar trials in Carmichael, CA

By research site
Research Site· Carmichael, CAResearch Site· Los Angeles, CAResearch Site· Mission Viejo, CAResearch Site· Thousand Oaks, CAResearch Site· Atlanta, GAResearch Site· Savannah, GA

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