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

Completed · Phase 3 · Has a placebo group

Conditions studied: Hyperlipidemia

In brief

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 facts

Study ID

NCT01984424

Run by

Amgen

People needed

511

Starts

2013-12-10

Expected to finish

2017-11-21

Last updated by the study team

2018-11-29

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Male or female ≥ 18 to ≤ 80 years of age
• Subject not at LDL-C goal
• History of statin intolerance
• Lipid lowering therapy has been stable prior to enrolment for at least 4 weeks
• Fasting triglycerides ≤ 400 mg/dL

You may not qualify if…

• New York Heart Association (NYHA) III or IV heart failure
• Uncontrolled cardiac arrhythmia
• Uncontrolled hypertension
• Type 1 diabetes
• Poorly controlled type 2 diabetes
• Uncontrolled hypothyroidism or hyperthyroidism

Where it is running

• Research Site — Huntington Beach, California, United States
• Research Site — Los Angeles, California, United States
• Research Site — San Pedro, California, United States
• Research Site — Atlanta, Georgia, United States
• Research Site — Sterling, Illinois, United States
• Research Site — Kansas City, Kansas, United States
• Research Site — Baltimore, Maryland, United States
• Research Site — Towson, Maryland, United States
• Research Site — Ann Arbor, Michigan, United States
• Research Site — Rochester, Minnesota, United States
• Research Site — St Louis, Missouri, United States
• Research Site — New York, New York, United States
• Research Site — Durham, North Carolina, United States
• Research Site — Cleveland, Ohio, United States
• Research Site — York, Pennsylvania, United States
• Research Site — Charleston, South Carolina, United States
• Research Site — Houston, Texas, United States
• Research Site — Camperdown, New South Wales, Australia
• Research Site — Woolloongabba, Queensland, Australia
• Research Site — Ashford, South Australia, Australia
• Research Site — Vancouver, British Columbia, Canada
• Research Site — Hamilton, Ontario, Canada
• Research Site — London, Ontario, Canada
• Research Site — Peterborough, Ontario, Canada
• Research Site — Beverly Hills, California, United States

Full record on ClinicalTrials.gov

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