Goal Achievement After Utilizing an Anti-PCSK9 Antibody in Statin Intolerant Subjects-3

• Status: Completed
• Trial end date: 2017-11-21
• Target enrollment: 0
• Participant gender: All

Summary

The primary objective of this study was to evaluate the effect of 24 weeks of evolocumab administered subcutaneously (SC) every month, compared with ezetimibe, on low-density lipoprotein cholesterol (LDL-C) levels in adults with high cholesterol who are unable to tolerate an effective dose of a statin due to muscle-related side effects (MRSE).

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

Details

• Lead Sponsor: Amgen
• Treatments: Antibodies, Monoclonal; Atorvastatin; Atorvastatin Calcium; Evolocumab; Ezetimibe

Criteria

Inclusion Criteria:

• Male or female ≥ 18 to ≤ 80 years of age

• Subject not at LDL-C goal

• History of statin intolerance

• 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