Goal Achievement After Utilizing an Anti-PCSK9 Antibody in Statin Intolerant Subjects -2

Completed · Phase 3 · Has a placebo group

Conditions studied: Hyperlipidemia

In brief

The primary objective was to evaluate the effect of 12 weeks of subcutaneous (SC) evolocumab every 2 weeks (Q2W) and monthly (QM), compared with ezetimibe, on percent change from baseline in low-density lipoprotein cholesterol (LDL-C) in hypercholesterolemic adults unable to tolerate an effective dose of a statin (HMG-CoA (5-hydroxy-3-methylglutaryl-coenzyme A) reductase inhibitors).

Key facts

Study ID

NCT01763905

Run by

Amgen

People needed

307

Starts

2013-01-24

Expected to finish

2013-11-19

Last updated by the study team

2020-07-20

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
• Not on a statin or on a low dose statin with stable dose for at least 4 weeks
• History of intolerance to at least 2 statins
• Subject not at LDL-C goal
• 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 — Los Angeles, California, United States
• Research Site — Mission Viejo, California, United States
• Research Site — Thousand Oaks, 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 — Traverse City, Michigan, United States
• Research Site — St Louis, Missouri, United States
• Research Site — Henderson, Nevada, United States
• Research Site — Las Vegas, 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 — Cleveland, Ohio, United States
• Research Site — Norman, Oklahoma, United States
• Research Site — Houston, Texas, United States
• Research Site — Camperdown, New South Wales, Australia
• Research Site — Milton, Queensland, Australia
• Research Site — Melbourne, Victoria, Australia
• Research Site — Perth, Western Australia, Australia
• Research Site — Brussels, Belgium
• Research Site — Carmichael, California, United States

Full record on ClinicalTrials.gov

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