LDL-C Assessment With PCSK9 Monoclonal Antibody Inhibition Combined With Statin Therapy-2

• Status: Completed
• Trial end date: 2013-12-04
• Target enrollment: 0
• Participant gender: All

Summary

The primary objective was to evaluate the effect of 12 weeks of evolocumab administered subcutaneously every 2 weeks (Q2W) and monthly (QM) when used in combination with a statin, compared with placebo, on percent change from baseline in low-density lipoprotein cholesterol (LDL-C) in patients with primary hypercholesterolemia and mixed dyslipidemia.

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

Details

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

Criteria

Inclusion Criteria:

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

• Subjects not taking a statin must have fasting LDL-C of at least 150 mg/dL (4.0 mmol/L)

• Subjects already on a non-intensive statin must have fasting LDL-C at screening ≥ 100 mg/dL (2.6 mmol/L)

• Subjects already on a intensive statin must have fasting LDL-C at screening ≥ 80 mg/dL (2.1 mmol/L)

• Fasting triglycerides ≤ 400 mg/dL (4.5 mmol/L)

Exclusion Criteria:

• Statin intolerance

• New York Heart association (NYHA) III or IV heart failure

• Uncontrolled hypertension

• Uncontrolled cardiac arrhythmia

• Type 1 diabetes, poorly controlled type 2 diabetes

• Uncontrolled hypothyroidism or hyperthyroidism