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Home » Clinical Trials » Location » Florida » Orlando

Clinical Trial Details

Overview

Research Study Summary

A clinical research study of AMG 145, Placebo and Effective statin therapy for the treatment of Dyslipidemia

Research Study Title

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

Purpose

The primary hypothesis is that additional LDL-C lowering with Evolocumab (AMG 145) when used in addition to other treatment for dyslipidemia is well tolerated and decreases the risk of cardiovascular death, myocardial infarction, hospitalization for unstable angina, stroke, or coronary revascularization in subjects with clinically evident cardiovascular disease.

To Learn more
Phase

3

Gender

Both Male and Female

Age

40 to 85 Years

Overall Status

Recruiting

Lead Sponsor

Amgen

Duration

59 Months

Facility Type

N/A

Eligibility

Both Male and Female ages 40 Years to 85 Years

Inclusion Criteria:

  • Male or female ≥ 40 to ≤ 85 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)

Exclusion Criteria:

  • NYHA class III or IV, or last known left ventricular ejection fraction < 30%

  • Uncontrolled hypertension

  • Uncontrolled or recurrent ventricular tachycardia

  • Untreated hyperthyroidism or hypothyroidism

  • Homozygous familial hypercholesterolemia

  • LDL or plasma apheresis

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NCT ID: NCT01764633

Date Last Changed: September 17, 2014

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