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

Completed · Phase 2 · Has a placebo group

Conditions studied: Hyperlipidemia

In brief

The primary objective was to evaluate the effect of 12 weeks of subcutaneous evolocumab (AMG 145), compared with ezetimibe, on percent change from baseline in low-density lipoprotein cholesterol (LDL-C) in patients with hypercholesterolemia unable to tolerate an effective dose of a statin.

Key facts

Study ID

NCT01375764

Run by

Amgen

People needed

160

Starts

2011-07-28

Expected to finish

2012-05-08

Last updated by the study team

2022-11-07

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Male or female ≥ 18 to ≤ 75 years of age
• On a statin or a low dose statin with stable dose for at least 4 weeks
• Lipid lowering therapy has been stable prior to enrollment
• Fasting triglycerides must be < 400 mg/dL.
• Subject not at LDL-C goal

You may not qualify if…

• New York Heart Association (NYHA) III or IV heart failure or known left ventricular ejection fraction < 30%
• Uncontrolled cardiac arrhythmia
• Myocardial infarction, unstable angina, percutaneous coronary intervention (PCI), coronary artery bypass graft (CABG) or stroke within 3 months prior to randomization
• Type 1 diabetes or newly diagnosed type 2 diabetes (HbA1c > 8.5%)
• Uncontrolled hypertension

Where it is running

• Research Site — Anaheim, California, United States
• Research Site — Mission Viejo, California, United States
• Research Site — Westlake Village, California, United States
• Research Site — Atlanta, Georgia, United States
• Research Site — Atlanta, Georgia, United States
• Research Site — Savannah, Georgia, United States
• Research Site — Auburn, Maine, United States
• Research Site — Chevy Chase, Maryland, United States
• Research Site — Butte, Montana, United States
• Research Site — Henderson, Nevada, United States
• Research Site — Las Vegas, Nevada, United States
• Research Site — New York, New York, United States
• Research Site — Raleigh, North Carolina, United States
• Research Site — Akron, Ohio, United States
• Research Site — Cincinnati, Ohio, United States
• Research Site — Bristol, Tennessee, United States
• Research Site — Camperdown, New South Wales, Australia
• Research Site — Sydney, New South Wales, Australia
• Research Site — Melbourne, Victoria, Australia
• Research Site — Perth, Western Australia, Australia
• Research Site — Brussels, Belgium
• Research Site — Uccle, Belgium
• Research Site — Saint John’s, Newfoundland and Labrador, Canada
• Research Site — St. John's, Newfoundland and Labrador, Canada
• Research Site — Lachine, Quebec, Canada

Full record on ClinicalTrials.gov

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