Reduction of LDL-C With PCSK9 Inhibition in Heterozygous Familial Hypercholesterolemia Disorder Study-2

• Status: Completed
• Trial end date: 2013-12-19
• Target enrollment: 0
• Participant gender: All

Summary

The primary objective was to evaluate the effect of 12 weeks of evolocumab subcutaneously once every 2 weeks (Q2W) and once monthly (QM), compared with placebo, on percent change from baseline in low-density lipoprotein cholesterol (LDL-C) in adults with heterozygous familial hypercholesterolemia (HeFH).

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

Details

• Lead Sponsor: Amgen
• Treatments: Evolocumab

Criteria

Inclusion Criteria:

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

• Diagnosis of heterozygous familial hypercholesterolemia

• On a stable dose of an approved statin and lipid regulating medication

• Fasting LDL-C ≥ 100 mg/dL (2.6 mmol/L)

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

Exclusion Criteria:

• Homozygous familial hypercholesterolemia

• LDL or plasma apheresis

• 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