Study of Low-Density Lipoprotein Cholesterol (LDL-C) Reduction Using Evolocumab (AMG 145) in Japanese Patients With Advanced Cardiovascular Risk

Conditions

• Hyperlipidemia or Mixed Dyslipidemia at High Risk for Cardiovascular Events

Eligibility Criteria

Sex

ALL

Age

20 Years - 85 Years

Healthy Volunteers

Not accepted

Interventions

• Atorvastatin — DRUG
  Administered orally once a day
• Evolocumab — BIOLOGICAL
  Administered by subcutaneous injection
• Placebo to Evolocumab — OTHER
  Administered by subcutaneous injection

Study Details

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.

Key Dates

Start date

Oct 31, 2013

Status verified

Nov 2015

Primary completion

Jun 30, 2014

Completion

Jun 30, 2014

Study Design

Enrollment

409 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Placebo Comparator: A5 Placebo Q2W
  Participants received atorvastatin 5 mg (A5) once daily during the 4 week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks (Q2W) for 12 weeks.
• Placebo Comparator: A5 Placebo QM
  Participants received atorvastatin 5 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every month (QM) for 12 weeks.
• Experimental: A5 Evolocumab Q2W
  Participants received atorvastatin 5 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.
• Experimental: A5 Evolocumab QM
  Participants received atorvastatin 5 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month for 12 weeks.
• Placebo Comparator: A20 Placebo Q2W
  Participants received atorvastatin 20 mg (A20) once daily during the 4 week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks for 12 weeks.
• Other: A20 Placebo QM
  Participants received atorvastatin 20 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every month for 12 weeks.
• Experimental: A20 Evolocumab Q2W
  Participants received atorvastatin 20 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.
• Experimental: A20 Evolocumab QM
  Participants received atorvastatin 20 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month for 12 weeks.

Primary Outcome Measure

Percent Change From Baseline in Low-Density Lipoprotein Cholesterol (LDL-C) at the Mean of Weeks 10 and 12 [ Time Frame: Baseline and Weeks 10 and 12 ]