LDL-C Assessment With PCSK9 Monoclonal Antibody Inhibition Combined With Statin Therapy-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 evolocumab administered subcutaneously every 2 weeks (Q2W) and monthly (QM) when used in combination with a statin, compared with placebo, on percent change from baseline in low-density lipoprotein cholesterol (LDL-C) in patients with primary hypercholesterolemia and mixed dyslipidemia.

Key facts

Study ID

NCT01763866

Run by

Amgen

People needed

2067

Starts

2013-01-15

Expected to finish

2013-12-04

Last updated by the study team

2022-11-08

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
• Subjects not taking a statin must have fasting LDL-C of at least 150 mg/dL (4.0 mmol/L)
• Subjects already on a non-intensive statin must have fasting LDL-C at screening ≥ 100 mg/dL (2.6 mmol/L)
• Subjects already on a intensive statin must have fasting LDL-C at screening ≥ 80 mg/dL (2.1 mmol/L)
• Fasting triglycerides ≤ 400 mg/dL (4.5 mmol/L)

You may not qualify if…

• Statin intolerance
• New York Heart association (NYHA) III or IV heart failure
• Uncontrolled hypertension
• Uncontrolled cardiac arrhythmia
• Type 1 diabetes, poorly controlled type 2 diabetes
• Uncontrolled hypothyroidism or hyperthyroidism

Where it is running

• Research Site — Glendale, Arizona, United States
• Research Site — Tucson, Arizona, United States
• Research Site — Tucson, Arizona, United States
• Research Site — Carmichael, California, United States
• Research Site — Encino, California, United States
• Research Site — Long Beach, California, United States
• Research Site — Newport Beach, California, United States
• Research Site — San Diego, California, United States
• Research Site — Santa Ana, California, United States
• Research Site — Santa Rosa, California, United States
• Research Site — Thousand Oaks, California, United States
• Research Site — Torrance, California, United States
• Research Site — Tustin, California, United States
• Research Site — Westlake Village, California, United States
• Research Site — Littleton, Colorado, United States
• Research Site — Daytona Beach, Florida, United States
• Research Site — Jacksonville, Florida, United States
• Research Site — Melbourne, Florida, United States
• Research Site — Miami, Florida, United States
• Research Site — Port Charlotte, Florida, United States
• Research Site — Atlanta, Georgia, United States
• Research Site — Atlanta, Georgia, United States
• Research Site — Boise, Idaho, United States
• Research Site — Hammond, Indiana, United States
• Research Site — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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