LAPLACE-TIMI 57: Low-density Lipoprotein Cholesterol (LDL-C) Assessment With PCSK9 monoclonaL Antibody Inhibition Combined With Statin thErapy

Conditions

• Hyperlipidemia

Eligibility Criteria

Sex

ALL

Age

18 Years - 80 Years

Healthy Volunteers

Not accepted

Interventions

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

Study Details

To evaluate the effect of 12 weeks of subcutaneous (SC) evolocumab (AMG 145) administered every 2 weeks (Q2W) or every 4 weeks (Q4W), compared with placebo, on percent change from baseline in LDL-C when used in addition to a statin in adults with hypercholesterolemia.

Key Dates

Start date

Jul 1, 2011

Status verified

Nov 2022

Primary completion

Apr 5, 2012

Completion

Apr 5, 2012

Study Design

Enrollment

631 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 105 mg Q2W
  Participants received 105 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 350 mg Q4W
  Participants received 350 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 ]

Locations (55)

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