Reduction of LDL-C With PCSK9 Inhibition in Heterozygous Familial Hypercholesterolemia Disorder Study-2

Part of paid clinical trials in Scottsdale, Arizona.

Sponsor
Amgen
Study ID
NCT01763918
Phase
PHASE3
Status
Completed

Conditions

  • Hyperlipidemia

Eligibility Criteria

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

Interventions

  • Evolocumab — BIOLOGICAL
    Administered by subcutaneous injection
  • Placebo — DRUG
    Administered by subcutaneous injection

Study Details

The primary objective was to evaluate the effect of 12 weeks of evolocumab subcutaneously once every 2 weeks (Q2W) and once monthly (QM), compared with placebo, on percent change from baseline in low-density lipoprotein cholesterol (LDL-C) in adults with heterozygous familial hypercholesterolemia (HeFH).

Key Dates

Start date
Feb 7, 2013
Status verified
Jun 2019
Primary completion
Nov 27, 2013
Completion
Dec 19, 2013

Study Design

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

Arms

  • Placebo Comparator: Placebo Q2W
    Participants received placebo subcutaneous injection once every 2 weeks (Q2W) for up to 12 weeks.
  • Placebo Comparator: Placebo QM
    Participants received placebo subcutaneous injection once every month (QM) for up to 12 weeks.
  • Experimental: Evolocumab Q2W
    Participants received 140 mg evolocumab by subcutaneous injection once every 2 weeks for up to 12 weeks.
  • Experimental: Evolocumab QM
    Participants received 420 mg evolocumab by subcutaneous injection once a month 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 (2)

FacilityCityStateZIPSite coordinators
Research SiteScottsdaleArizona85258-
Research SiteCincinnatiOhio45227-

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