Monoclonal Antibody Against PCSK9 to Reduce Elevated Low-density Lipoprotein Cholesterol (LDL-C) in Adults Currently Not Receiving Drug Therapy for Easing Lipid Levels

Conditions

• Hyperlipidemia

Eligibility Criteria

Sex

ALL

Age

18 Years - 75 Years

Healthy Volunteers

Not accepted

Interventions

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

Study Details

The primary objective was to evaluate the effect of 12 weeks of subcutaneous evolocumab (AMG 145) every 2 weeks (Q2W) or every 4 weeks (Q4W), compared with placebo, on the percent change from baseline in LDL-C when used as monotherapy in adults with hypercholesterolemia.

Key Dates

Start date

Jul 6, 2011

Status verified

Nov 2022

Primary completion

Mar 2, 2012

Completion

Mar 2, 2012

Study Design

Enrollment

411 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.
• Active Comparator: Ezetimibe
  Participants received 10 mg ezetimibe orally once a day 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 (41)

Find similar trials in Birmingham, AL

Related Studies

• Preventative Screening and Health Coaching in a Food Insecure Population
  Not Yet Recruiting · Rush University Medical Center · Chicago, Illinois
• Inspire HER: Inspiring the Heart and Emotions for Radical Health
  Recruiting · University of Alabama at Birmingham · Birmingham, Alabama
• Duke Cardiometabolic Prevention Clinic's Impact on High-risk Cardiovascular Patients With Uncontrolled Risk Factors
  Not Yet Recruiting · Duke University · Durham, North Carolina
• Targeting Metabolic Syndrome From the Emergency Department Through Mixed-Methods: Pilot Trial
  Recruiting · Indiana University · Indianapolis, Indiana