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Amgen 145

Amgen 145

Objective

Status
Enrolling

Condition
Dyslipidemia

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

Purpose
To see whether treatment of dyslipidemia with AMG 145 in people who have experienced a prior myocardial infarction or stroke, and who are taking a highly effective dose of a statin, reduces the risk of recurring or additional cardiovascular events. 

Phase
III

Key Inclusion Criteria

  • Signed informed consent
  • Male or female ≥ 40 to ≤ 80 years of age at signing of informed consent
  • History of clinically evident cardiovascular disease within 5 years of screening as evidenced by ANY of the following:
    • Diagnosis of myocardial infarction
    • Diagnosis of stroke
  • History of Type 2 Diabetes 

If not diabetic, ANY of the following:

  • Age >65 years (and <80years)
  • Index event within 6 months prior to screening
  • Additional diagnosis of myocardial infarction or stroke
  • History of symptomatic peripheral vascular disease or amputation due to atherosclerotic disease

Two or more of the following risk factors:

  • HDL-C < 40 mg/dl for men and <50 mg/dl for women by central laboratory at screening
  • Residual coronary artery disease within > 40% stenosis in > 2 large vessels
  • Current smoker
  • History of non myocardial infarction related coronary revascularization
  • Age > 60

Other protocol-defined inclusion/exclusion may apply 

Key Exclusion Criteria

  • Uncontrolled or recurrent ventricular tachycardia
  • Known hemorrhagic stroke
  • Planned or expected cardiac surgery or revascularization w/in 3 mo after randomization
  • Uncontrolled hypertension defined as sitting Systolic BP > 180mmHg or diastolic BP >110mmHg
  • Recipient of any major organ transplant (e.g., lung, liver, heart, bone marrow)
  • Severe, concomitant non-cardiovascular  disease with life expectancy < 3 years
  • Known major active infection, major hematologic, renal, metabolic, gastrointestinal or endocrine dysfunction
  • Currently enrolled in another investigation device or drug study
  • Uncontrolled hypothyroidism or hyperthyroidism
  • Severe renal dysfunction
  • Active live disease or hepatic dysfunction

Other protocol-defined inclusion/exclusion may apply

ClinicalTrials.gov Identifier

 

IRB Protocol Number
AMG 145 20110118
Principal Investigator(s)
Rabeea Aboufakher, MD

Clinical Trial Categories

  • Cardiology
Sponsor(s)
Amgen
Contact
Brenda Westacott, CCRC at 701-780-1845
or bwestacott@altru.org