Trial Evaluating PCSK9 Antibody in Subjects With LDL Receptor Abnormalities

Part of paid clinical trials in New York, New York.

Sponsor
Amgen
Study ID
NCT01588496
Phase
PHASE2/PHASE3
Status
Completed

Conditions

  • Homozygous Familial Hypercholesterolemia

Eligibility Criteria

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

Interventions

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

Study Details

A study to determine the safety, tolerability, and efficacy of evolocumab (AMG 145) in patients with homozygous familial hypercholesterolemia (HoFH).

Key Dates

Start date
Apr 5, 2012
Status verified
Nov 2018
Primary completion
Jan 31, 2014
Completion
Jan 31, 2014

Study Design

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

Arms

  • Experimental: Part A: Evolocumab
    Participants received open-label evolocumab 420 mg subcutaneously once a month for 12 weeks.
  • Experimental: Part B: Evolocumab
    Participants received double-blind evolocumab 420 mg subcutaneously once a month for 12 weeks.
  • Placebo Comparator: Part B: Placebo
    Participants received double-blind placebo subcutaneously once a month for 12 weeks.

Primary Outcome Measure

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

Locations (2)

FacilityCityStateZIPSite coordinators
Research SiteNew YorkNew York10032-
Research SiteCincinnatiOhio45227-

Find similar trials in New York, NY

By research site
Research Site· New York, NYResearch Site· Cincinnati, OH

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