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OpenTrials
Completed

NCT Number: NCT01375777

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

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.

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Key information

Conditions

Hyperlipidemia Dyslipidemias Hypercholesterolemia Hypercholesterolemia, Autosomal Dominant, 3 Hyperlipidemias Lipid Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Research Site, Maroubra, New South Wales, Australia

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Male or female ≥ 18 to ≤ 75 years of age
  • Low density lipoprotein cholesterol (LDL-C) ≥ 100 mg/dL and < 190 mg/dL
  • Framingham risk score of 10% or less
  • Fasting triglycerides < 400 mg/dL

Exclusion criteria

  • History of coronary heart disease
  • New York Heart Association (NYHA) II - IV heart failure
  • Uncontrolled cardiac arrhythmia
  • Uncontrolled hypertension

Treatment and study plan

Evolocumab

Biological

Administered by subcutaneous injection

Other names: AMG 145, Repatha

ezetimibe

Drug

Administered orally once a day

Other names: Zetia

Placebo to Evolocumab

Other

Administered by subcutaneous injection

Primary outcomes

  1. Percent Change From Baseline in Low-Density Lipoprotein Cholesterol (LDL-C) at Week 12

    Time frame: Baseline and Week 12

    LDL-C was measured using ultracentrifugation.

Secondary outcomes

  1. Change From Baseline in LDL-C at Week 12

    Time frame: Baseline and Week 12

    LDL-C was measured using ultracentrifugation.

  2. Percent Change From Baseline in Non-High-Density Lipoprotein Cholesterol (Non-HDL-C) at Week 12

    Time frame: Baseline and Week 12

  3. Percent Change From Baseline in Apolipoprotein B at Week 12

    Time frame: Baseline and Week 12

  4. Percent Change From Baseline in Total Cholesterol/HDL-C Ratio at Week 12

    Time frame: Baseline and Week 12

  5. Percent Change From Baseline in Apolipoprotein B/Apolipoprotein A-1 Ratio at Week 12

    Time frame: Baseline and Week 12

Sponsors and collaborators

Lead sponsor

Amgen

Industry

Registry information

Official study title

A Randomized, Placebo- and Ezetimibe-controlled, Dose-ranging Study to Evaluate Tolerability and Efficacy of AMG 145 on LDL-C in Hypercholesterolemic Subjects With a 10-year Framingham Risk Score of 10% or Less

Acronym: MENDEL

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Jun 17, 2011
Registry last updated
Nov 8, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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