Goal Achievement After Utilizing an Anti-PCSK9 Antibody in Statin Intolerant Subjects-3

Part of paid clinical trials in Beverly Hills, California.

Sponsor
Amgen
Study ID
NCT01984424
Phase
PHASE3
Status
Completed

Conditions

  • Hyperlipidemia

Eligibility Criteria

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

Interventions

  • Atorvastatin — DRUG
    Atorvastatin was supplied as over-encapsulated 20 mg tablets
  • Placebo to Atorvastatin — DRUG
    Placebo matching to atorvastatin supplied as over-encapsulated tablets
  • Placebo to Ezetimibe — OTHER
    Placebo matching to Ezetimibe supplied as over-encapsulated tablets.
  • Ezetimibe — DRUG
    Ezetimibe was supplied as 10 mg tablets, over-encapsulated for blinding.
  • Placebo to Evolocumab — OTHER
    Placebo matching to evolocumab supplied as single-use prefilled autoinjector/pen(s)
  • Evolocumab — DRUG
    Evolocumab supplied as single-use prefilled autoinjector/pen(s)

Study Details

The primary objective of this study was to evaluate the effect of 24 weeks of evolocumab administered subcutaneously (SC) every month, compared with ezetimibe, on low-density lipoprotein cholesterol (LDL-C) levels in adults with high cholesterol who are unable to tolerate an effective dose of a statin due to muscle-related side effects (MRSE).

Key Dates

Start date
Dec 10, 2013
Status verified
Nov 2018
Primary completion
Nov 10, 2015
Completion
Nov 21, 2017

Study Design

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

Arms

  • Other: Part A: Atorvastatin 20 mg => Placebo
    Participants received atorvastatin 20 mg orally for 10 weeks (period 1) followed by placebo orally for 10 weeks (period 2), separated by a 2-week washout period.
  • Other: Part A: Placebo => Atorvastatin 20 mg
    Participants received placebo orally for 10 weeks (period 1) followed by atorvastatin 20 mg orally for 10 weeks (period 2), separated by a 2-week washout period.
  • Active Comparator: Part B: Ezetimibe
    Participants received 10 mg ezetimibe orally only a day and placebo to evolocumab by subcutaneous injection once a month for 24 weeks.
  • Experimental: Part B: Evolocumab
    Participants received 420 mg evolocumab by subcutaneous injection once a month and placebo to ezetimibe orally once a day for 24 weeks.
  • Experimental: Part C: Open-label Evolocumab
    Participants who completed part B and were eligible to proceed to open-label extension part C and could choose quarterly between evolocumab 420 mg once a month or evolocumab 140 mg every 2 weeks for up to 2 years.

Primary Outcome Measure

Percent Change From Baseline in LDL-C at the Mean of Weeks 22 and 24 [ Time Frame: Baseline and weeks 22 and 24 ]

Locations (18)

FacilityCityStateZIPSite coordinators
Research SiteBeverly HillsCalifornia90211-
Research SiteHuntington BeachCalifornia92648-
Research SiteLos AngelesCalifornia90048-
Research SiteSan PedroCalifornia90732-
Research SiteAtlantaGeorgia30322-
Research SiteSterlingIllinois61081-
Research SiteKansas CityKansas66160-
Research SiteBaltimoreMaryland21201-
Research SiteTowsonMaryland21204-
Research SiteAnn ArborMichigan48106-
Research SiteRochesterMinnesota55905-
Research SiteSt LouisMissouri63110-
Research SiteNew YorkNew York10029-
Research SiteDurhamNorth Carolina27710-
Research SiteClevelandOhio44195-
Research SiteYorkPennsylvania17405-
Research SiteCharlestonSouth Carolina29425-
Research SiteHoustonTexas77030-

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