Last updated on March 2013

Further Cardiovascular Outcomes Research with PCSK9 Inhibition in Subjects with Elevated Risk


Brief description of study

Further Cardiovascular Outcomes Research with PCSK9 Inhibition in Subjects with Elevated Risk

Detailed Study Description

A Double-blind, Randomized, Placebo-controlled, Multicenter Study Assessing the Impact of Additional LDL-Cholesterol Reduction on Major Cardiovascular Events When AMG 145 is Used in Combination With Statin Therapy In Patients With Clinically Evident Cardiovascular Disease

Patient Inclusion Criteria:

  • Male or female ≥ 40 to ≤ 80 years of age
  • History of clinically evident cardiovascular disease at high risk for a recurrent event
  • Fasting LDL-C ≥ 70 mg/dL (≥ 1.8 mmol/L) ) or non-HDL-C ≥ 100 mg/dL (> 2.6 mmol/L)
  • Fasting triglycerides ≤ 400 mg/dL (4.5 mmol/L)

Patient Exclusion Criteria:

  • NYHA class III or IV, or last known left ventricular ejection fraction < 30%
  • Uncontrolled hypertension
  • Uncontrolled or recurrent ventricular tachycardia
  • Uncontrolled hyperthyroidism or hypothyroidism
  • Homozygous familial hypercholesterolemia
  • LDL or plasma apheresis
  • Other protocol specific inclusion/exclusion criteria apply

Clinical Study Identifier: TX136676

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