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

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Amgen

Status and phase

Completed
Phase 3

Conditions

Hyperlipidemia

Treatments

Drug: Placebo
Biological: Evolocumab

Study type

Interventional

Funder types

Industry

Identifiers

NCT01763918
20110117
2012-001365-32 (EudraCT Number)

Details and patient eligibility

About

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).

Enrollment

331 patients

Sex

All

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

331 participants in 4 patient groups, including a placebo group

Placebo Q2W
Placebo Comparator group
Description:
Participants received placebo subcutaneous injection once every 2 weeks (Q2W) for up to 12 weeks.
Treatment:
Drug: Placebo
Placebo QM
Placebo Comparator group
Description:
Participants received placebo subcutaneous injection once every month (QM) for up to 12 weeks.
Treatment:
Drug: Placebo
Evolocumab Q2W
Experimental group
Description:
Participants received 140 mg evolocumab by subcutaneous injection once every 2 weeks for up to 12 weeks.
Treatment:
Biological: Evolocumab
Evolocumab QM
Experimental group
Description:
Participants received 420 mg evolocumab by subcutaneous injection once a month for up to 12 weeks.
Treatment:
Biological: Evolocumab

Trial contacts and locations

39

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Data sourced from clinicaltrials.gov

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