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

Status:	Completed
Conditions:	High Cholesterol
Therapuetic Areas:	Cardiology / Vascular Diseases
Healthy:	No
Age Range:	18 - 80
Updated:	3/8/2019
Start Date:	January 24, 2013

A Double-blind, Randomized, Multicenter Study to Evaluate Safety and Efficacy of AMG 145, Compared With Ezetimibe, in Hypercholesterolemic Subjects Unable to Tolerate an Effective Dose of a HMG-CoA Reductase Inhibitor

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).

Inclusion Criteria:

- 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

Exclusion Criteria:

- 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

We found this trial at

sites

Clinical Trial Facility in Akron Ohio

Akron, Ohio

from

Akron, OH