Goal Achievement After Utilizing an Anti-PCSK9 Antibody in Statin Intolerant Subjects-4

• Status: Completed
• Trial end date: 2018-05-26
• Target enrollment: 0
• Participant gender: All

Summary

The primary objective of the study was to evaluate the effect of 12 weeks of subcutaneous (SC) evolocumab 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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Amgen
• Collaborator: Data Monitoring Committee (DMC)
• Treatments: Antibodies, Monoclonal; Evolocumab; Ezetimibe

Criteria

Inclusion Criteria:

• Male or female ≥ 20 to ≤ 80 years of age

• Japanese by self-identification

• Not on a statin or on a low dose statin with stable dose for at least 4 weeks.

• Subject not at LDL-C goal

• History of statin intolerance to at least 2 statins

• Lipid lowering therapy has been stable prior to screening 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