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

Conditions

• Hypercholesterolemia and High Risk for Cardiovascular Events

Eligibility Criteria

Sex

ALL

Age

20 Years - 80 Years

Healthy Volunteers

Not accepted

Interventions

• Evolocumab — BIOLOGICAL
  Administered by subcutaneous injection
• Placebo — OTHER
  Administered by subcutaneous injection

Study Details

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.

Key Dates

Start date

Jul 10, 2012

Status verified

Nov 2018

Primary completion

May 14, 2013

Study Design

Enrollment

310 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Placebo Comparator: Placebo Q2W
  Participants received placebo subcutaneous injection once every 2 weeks (Q2W) for 12 weeks.
• Placebo Comparator: Placebo Q4W
  Participants received placebo subcutaneous injection once every 4 weeks (Q4W) for 12 weeks.
• Experimental: Evolocumab 70 mg Q2W
  Participants received 70 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.
• Experimental: Evolocumab 140 mg Q2W
  Participants received 140 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.
• Experimental: Evolocumab 280 mg Q4W
  Participants received 280 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.
• Experimental: Evolocumab 420 mg Q4W
  Participants received 420 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.

Primary Outcome Measure

Percent Change From Baseline in Low-Density Lipoprotein Cholesterol (LDL-C) at Week 12 [ Time Frame: Baseline and Week 12 ]