Reduction of Low-Density Lipoprotein Cholesterol (LDL-C) With PCSK9 Inhibition in Heterozygous Familial Hypercholesterolemia Disorder Study

Conditions

• Hypercholesterolemia, Familial

Eligibility Criteria

Sex

ALL

Age

18 Years - 75 Years

Healthy Volunteers

Not accepted

Interventions

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

Study Details

The primary objective of this study was to evaluate the effect of 12 weeks of subcutaneous evolocumab (AMG 145), compared with placebo, on percent change from baseline in LDL-C in adults with heterozygous familial hypercholesterolemia (HeFH).

Key Dates

Start date

Aug 2, 2011

Status verified

Nov 2022

Primary completion

May 16, 2012

Completion

May 16, 2012

Study Design

Enrollment

168 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Placebo Comparator: Placebo
  Participants received placebo subcutaneous injection once every 4 weeks for 12 weeks.
• Experimental: Evolocumab 350 mg
  Participants received 350 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.
• Experimental: Evolocumab 420 mg
  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 ]