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Completed

NCT Number: NCT01763918

Reduction of LDL-C With PCSK9 Inhibition in Heterozygous Familial Hypercholesterolemia Disorder Study-2

The primary objective was to evaluate the effect of 12 weeks of evolocumab subcutaneously once every 2 weeks (Q2W) and once monthly (QM), compared with placebo, on percent change from baseline in low-density lipoprotein cholesterol (LDL-C) in adults with heterozygous familial hypercholesterolemia (HeFH).

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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, Camperdown, New South Wales, Australia

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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
  • Diagnosis of heterozygous familial hypercholesterolemia
  • On a stable dose of an approved statin and lipid regulating medication
  • Fasting LDL-C ≥ 100 mg/dL (2.6 mmol/L)
  • Fasting triglycerides ≤ 400 mg/dL (4.5 mmol/L)

Exclusion criteria

  • Homozygous familial hypercholesterolemia
  • LDL or plasma apheresis
  • New York Heart Association (NYHA) III or IV heart failure
  • Uncontrolled cardiac arrhythmia
  • Uncontrolled hypertension
  • 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

Placebo

Drug

Administered by subcutaneous injection

Primary outcomes

  1. Percent Change From Baseline in 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 With Mean LDL-C at Weeks 10 and 12 of Less Than 70 mg/dL (1.8 mmol/L)

    Time frame: Weeks 10 and 12

  4. Percentage of Participants With LDL-C < 70 mg/dL (1.8 mmol/L) 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 the Total Cholesterol/HDL-C Ratio at the Mean of Weeks 10 and 12

    Time frame: Baseline and Weeks 10 and 12

  10. Percent Change From Baseline in the Total Cholesterol/HDL-C 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 HDL-C at the Mean of Weeks 10 and 12

    Time frame: Baseline and Weeks 10 and 12

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

    Time frame: Baseline and Week 12

  19. 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

  20. Percent Change From Baseline in VLDL-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-controlled, Multicenter Study to Evaluate Safety, Tolerability and Efficacy of AMG 145 on LDL-C in Subjects With Heterozygous Familial Hypercholesterolemia

Acronym: RUTHERFORD-2

Important dates

Study start
2013
Primary completion
2013
Study completion
2013
First posted
Jan 9, 2013
Registry last updated
Jun 17, 2019

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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