Ascending Multiple Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Evolocumab (AMG 145) in Adults With Hyperlipidemia on Stable Doses of a Statin

Sponsor
Amgen
Study ID
NCT01133522
Phase
PHASE1
Status
Completed

Conditions

  • Hyperlipidemia

Eligibility Criteria

Sex
ALL
Age
18 Years - 70 Years
Healthy Volunteers
Not accepted

Interventions

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

Study Details

The purpose of the study is to evaluate the safety and tolerability of multiple doses of evolocumab when given as an add-on to stable statin therapy.

Key Dates

Start date
Jun 1, 2010
Status verified
Nov 2018
Primary completion
Sep 14, 2011
Completion
Sep 14, 2011

Study Design

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

Arms

  • Experimental: Evolocumab
    Participants received one of 5 dose levels of evolocumab administered as multiple subcutaneous doses.
  • Placebo Comparator: Placebo
    Participants received matching placebo dose regimens by subcutaneous injection.

Primary Outcome Measure

Number of Participants With Adverse Events [ Time Frame: From the first dose of study drug until Day 85 ]

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