Monoclonal Antibody Against PCSK9 to Reduce Elevated LDL-C in Subjects Currently Not Receiving Drug Therapy for Easing Lipid Levels-2

Conditions

• Hyperlipidemia

Eligibility Criteria

Sex

ALL

Age

18 Years - 80 Years

Healthy Volunteers

Not accepted

Interventions

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

Study Details

The primary objective was to evaluate the effect of 12 weeks of evolocumab subcutaneous (SC) monotherapy every 2 weeks (Q2W) and monthly (QM), compared with placebo and ezetimibe, on percent change from baseline in low-density lipoprotein cholesterol (LDL-C) in adults with a 10-year Framingham risk score of 10% or less.

Key Dates

Start date

Jan 21, 2013

Status verified

Nov 2022

Primary completion

Oct 10, 2013

Completion

Oct 29, 2013

Study Design

Enrollment

615 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) and placebo tablets once a day for up to 12 weeks.
• Placebo Comparator: Placebo QM
  Participants received placebo subcutaneous injection once every month (QM) and placebo tablets once a day for up to 12 weeks.
• Active Comparator: Ezetimibe (Q2W)
  Participants received placebo subcutaneous injection once every 2 weeks and 10 mg ezetimibe orally once a day for up to 12 weeks.
• Active Comparator: Ezetimibe (QM)
  Participants received placebo subcutaneous injection once a month and 10 mg ezetimibe orally once a day for up to 12 weeks.
• Experimental: Evolocumab Q2W
  Participants received 140 mg evolocumab by subcutaneous injection once every 2 weeks and placebo tablets once a day for up to 12 weeks.
• Experimental: Evolocumab QM
  Participants received 420 mg evolocumab by subcutaneous injection once a month and placebo tablets once a day for up to 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 (47)

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