A Study to Evaluate Tolerability and Efficacy of Evolocumab (AMG 145) in Japanese Subjects (AMG145)

Amgen

Status and phase: Completed; Phase 2

Conditions: Hypercholesterolemia and High Risk for Cardiovascular Events

Treatments: Biological: Evolocumab; Other: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT01652703

20110231

Details and patient eligibility

About

The primary objective is to evaluate the effect of 12 weeks of subcutaneous evolocumab every 2 weeks or every 4 weeks, compared with placebo, on percent change from baseline in low-density lipoprotein cholesterol (LDL-C) when used in addition to statin therapy in Japanese adults with hypercholesterolemia and high cardiovascular risk.

Enrollment: 310 patients

Sex: All

Ages: 20 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria: Japanese adult, on statin, with or without ezetimibe, with stable dose(s) for at least 4 weeks, fasting LDL-C greater than or equal to 115 mg/dL (3.0 mmol/L), fasting triglycerides less than or equal to 400 mg/dL (4.5 mmol/L); Exclusion Criteria: New York Heart Association (NYHA) class III or IV, poorly controlled hypertension, recently diagnosed or poorly controlled type 2 diabetes, last known left ventricular ejection fraction < 30%, myocardial infarction, unstable angina, percutaneous coronary intervention (PCI), coronary artery bypass graft (CABG), stroke, planned cardiac surgery or revascularization within 6 months of randomization, uncontrolled cardiac arrhythmia.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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310 participants in 6 patient groups, including a placebo group

Placebo Q2W

Placebo Comparator group

Description:

Participants received placebo subcutaneous injection once every 2 weeks (Q2W) for 12 weeks.

Treatment:

Other: Placebo

Placebo Q4W

Placebo Comparator group

Description:

Participants received placebo subcutaneous injection once every 4 weeks (Q4W) for 12 weeks.

Treatment:

Other: Placebo

Evolocumab 70 mg Q2W

Experimental group

Description:

Participants received 70 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.

Treatment:

Biological: Evolocumab

Evolocumab 140 mg Q2W

Experimental group

Description:

Participants received 140 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.

Treatment:

Biological: Evolocumab

Evolocumab 280 mg Q4W

Experimental group

Description:

Participants received 280 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.

Treatment:

Biological: Evolocumab

Evolocumab 420 mg Q4W

Experimental group

Description:

Participants received 420 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.

Treatment:

Biological: Evolocumab