Hyperlipidemia or Mixed Dyslipidemia at High Risk for Cardiovascular Events Clinical Trial
Official title:
A Double-blind, Randomized, Placebo-controlled, Multicenter Study to Evaluate Safety, Tolerability and Efficacy of Evolocumab (AMG 145) on LDL-C in Combination With Statin Therapy in Japanese Subjects With High Cardiovascular Risk and With Hyperlipidemia or Mixed Dyslipidemia
The primary objective of the study was to evaluate the effect of 12 weeks of subcutaneous evolocumab administered every 2 weeks and once a month, compared with placebo, on percent change from baseline in LDL-C when used in combination with statin therapy in adults with high cardiovascular risk and with hyperlipidemia or mixed dyslipidemia.
After a screening and placebo run-in period, eligible patients were randomized in a 1:1
ratio to 1 of 2 open-label background statin treatments (atorvastatin 5 mg or 20 mg daily
[QD]) and entered a 4-week lipid stabilization period. After the lipid stabilization period,
eligible patients were randomized in a 1:1:1:1 ratio to investigational product (evolocumab
or placebo) for the 12-week treatment period.
Both randomizations were stratified by subject diagnosis and lipid-lowering therapy as
follows:
- current or prior diagnosis of heterozygous familial hypercholesterolemia (HeFH)
- no diagnosis of HeFH and receiving intensive lipid-lowering therapy
- no diagnosis of HeFH and receiving non-intensive lipid-lowering therapy. A participant
was considered randomized into the study after successfully completing the screening
period, meeting all inclusion/exclusion criteria including meeting final laboratory
safety criteria, and undergoing both randomization procedures.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment