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

Status:	Completed
Conditions:	High Cholesterol
Therapuetic Areas:	Cardiology / Vascular Diseases
Healthy:	No
Age Range:	18 - 75
Updated:	11/4/2018
Start Date:	July 28, 2011
End Date:	May 8, 2012

A Randomized, Multicenter Study to Evaluate Tolerability and Efficacy of AMG 145 on LDL-C, 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 evolocumab (AMG
145), compared with ezetimibe, on percent change from baseline in low-density lipoprotein
cholesterol (LDL-C) in patients with hypercholesterolemia unable to tolerate an effective
dose of a statin.

Inclusion Criteria:

- Male or female ≥ 18 to ≤ 75 years of age

- On a statin or a low dose statin with stable dose for at least 4 weeks

- Lipid lowering therapy has been stable prior to enrollment

- Fasting triglycerides must be < 400 mg/dL.

- Subject not at LDL-C goal

Exclusion Criteria:

- New York Heart Association (NYHA) III or IV heart failure or known left ventricular
ejection fraction < 30%

- Uncontrolled cardiac arrhythmia

- Myocardial infarction, unstable angina, percutaneous coronary intervention (PCI),
coronary artery bypass graft (CABG) or stroke within 3 months prior to randomization

- Type 1 diabetes or newly diagnosed type 2 diabetes (HbA1c > 8.5%)

- Uncontrolled hypertension

We found this trial at

sites

Clinical Trial Facility in Akron Ohio

Akron, Ohio

from

Akron, OH