Skip to main content
OpenTrials
Completed

NCT Number: NCT01763827

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Hyperlipidemia Dyslipidemias Hypercholesterolemia Hyperlipidemias Lipid Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Research Site, Darlinghurst, 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 ≤ 80 years of age
  • National Cholesterol Education Program Adult Treatment Panel III (NCEP ATP III) Framingham risk score of 10% or less
  • Fasting LDL-C ≥ 100 mg/dL (2.6 mmol/L) and <190 mg/dL
  • Fasting triglycerides ≤ 400 mg/dL (4.5 mmol/L)

Exclusion criteria

  • History of coronary heart disease
  • New York Heart Association (NYHA) III or IV heart failure
  • Uncontrolled cardiac arrhythmia
  • Uncontrolled hypertension
  • Diabetes mellitus (Type 1 diabetes, poorly controlled type 2 diabetes)
  • Uncontrolled hypothyroidism or hyperthyroidism

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

Biological

Administered by subcutaneous injection

Placebo to Ezetimibe

Other

Administered orally once daily

Primary outcomes

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

    Time frame: Baseline and Week 12

  2. Percent Change From Baseline in LDL-C at the Mean of Weeks 10 and 12

    Time frame: Baseline and Weeks 10 and 12

Secondary outcomes

  1. Change From Baseline in LDL-C at the Mean of Weeks 10 and 12

    Time frame: Baseline and Weeks 10 and 12

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

    Time frame: Baseline and Week 12

  3. Percentage of Participants Who Achieved a Mean LDL-C at Weeks 10 and 12 of Less Than 70 mg/dL

    Time frame: Weeks 10 and 12

  4. Percentage of Participants Who Achieved LDL-C < 70 mg/dL at Week 12

    Time frame: Week 12

  5. Percent Change From Baseline in Non-high-density Lipoprotein Cholesterol (Non-HDL-C) at the Mean of Weeks 10 and 12

    Time frame: Baseline and Weeks 10 and 12

  6. Percent Change From Baseline in Non-HDL-C at Week 12

    Time frame: Baseline and Week 12

  7. Percent Change From Baseline in Apolipoprotein B at the Mean of Weeks 10 and 12

    Time frame: Baseline and Weeks 10 and 12

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

    Time frame: Baseline and Week 12

  9. Percent Change From Baseline in Total Cholesterol/High Density Lipoprotein-cholesterol Ratio at the Mean of Weeks 10 and 12

    Time frame: Baseline and Weeks 10 and 12

  10. Percent Change From Baseline in Total Cholesterol/High Density Lipoprotein-cholesterol Ratio at Week 12

    Time frame: Baseline and Week 12

  11. Percent Change From Baseline in Apolipoprotein B/Apolipoprotein A1 Ratio at the Mean of Weeks 10 and 12

    Time frame: Baseline and Weeks 10 and 12

  12. Percent Change From Baseline in Apolipoprotein B/Apolipoprotein A1 Ratio at Week 12

    Time frame: Baseline and Week 12

  13. Percent Change From Baseline in Lipoprotein (a) at the Mean of Weeks 10 and 12

    Time frame: Baseline and Weeks 10 and 12

  14. Percent Change From Baseline in Lipoprotein (a) at Week 12

    Time frame: Baseline and Week 12

  15. Percent Change From Baseline in Triglycerides at the Mean of Weeks 10 and 12

    Time frame: Baseline and Weeks 10 and 12

  16. Percent Change From Baseline in Triglycerides at Week 12

    Time frame: Baseline and Week 12

  17. Percent Change From Baseline in Very Low Density Lipoprotein Cholesterol (VLDL-C) at the Mean of Weeks 10 and 12

    Time frame: Baseline and Weeks 10 and 12

  18. Percent Change From Baseline in VLDL-C at Week 12

    Time frame: Baseline and Week 12

  19. Percent Change From Baseline in High-density Lipoprotein Cholesterol (HDL-C) at the Mean of Weeks 10 and 12

    Time frame: Baseline and Weeks 10 and 12

  20. Percent Change From Baseline in HDL-C at Week 12

    Time frame: Baseline and Week 12

Sponsors and collaborators

Lead sponsor

Amgen

Industry

Registry information

Official study title

A Double-blind, Randomized, Placebo and Ezetimibe-controlled, Multicenter Study to Evaluate Safety and Efficacy of Lipid Lowering Monotherapy With AMG 145 in Subjects With a 10-Year Framingham Risk Score of 10% or Less

Acronym: MENDEL-2

Important dates

Study start
2013
Primary completion
2013
Study completion
2013
First posted
Jan 9, 2013
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.

Related clinical trials

Published trials that share one or more normalized conditions with this study.