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Study Complete
Sponsor ID
20090158

Reduction of Low-Density Lipoprotein Cholesterol (LDL-C) with PCSK9 inhibition in Heterozygous Familial Hypercholesterolemia Disorder StudyRUTHERFORD

Sponsor ID
20090158
Clinicaltrials.gov ID
NCT01375751
EUCTIS ID
N/A
EudraCT ID
N/A
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Study Details

The primary objective of this study was to evaluate the effect of 12 weeks of subcutaneous evolocumab (AMG 145), compared with placebo, on percent change from baseline in LDL-C in adults with heterozygous familial hypercholesterolemia (HeFH).

Additional Study Details

Phase
Phase 2
Product
Evolocumab
Type
Interventional
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment
168
Additional Study Details

Protocol Summary

Primary Outcome Measures

The percent change from baseline in Low-Density Lipoprotein Cholesterol (LDL-C) at week 12

Timeframe: 12 weeks

Secondary Outcome Measures

Absolute change from baseline in Low-Density Lipoprotein Cholesterol (LDL-C) at week 12

Timeframe: 12 weeks

Percent change from baseline in non-High Density Lipoprotein Cholesterol (HDL-C) at week 12

Timeframe: 12 weeks

Percent change from baseline in Apolipoprotein B (ApoB) at week 12

Timeframe: 12 weeks

Percent change from baseline in the total cholesterol/High Density Lipoprotein Cholesterol (HDL-C) at week 12

Timeframe: 12 weeks

Percent change from baseline in Apolipoprotein B (ApoB)/Apolipoprotein A-1 (ApoA1) ratio at week 12

Timeframe: 12 weeks

Study Documents

Study Synopsis
Available Language(s): English
Download Document(s)

Locations

No locations found.
Study Info
Age
18 - 75 Years
Condition
  • Cholesterol
    • Sex
    All
    Trial Dates
    Aug 2011 - May 2012
    Inclusion and Exclusion Criteria
    Inclusion Criteria:
    - Male or female ≥ 18 to ≤ 75 years of age - Diagnosis of heterozygous familial hypercholesterolemia by having met the diagnostic criteria outlined by the Simon Broome Register Group (Scientific Steering Committee 1991) - On an approved statin, with or without ezetimibe, with stable dose(s) for at least 4 weeks - Fasting Low-Density Lipoprotein Cholesterol (LDL-C) ≥ 100 mg/dL - Fasting triglycerides ≤ 400 mg/dL
    Exclusion Criteria:
    - Homozygous familial hypercholesterolemia - Low-Density Lipoprotein (LDL) or plasma apheresis within 12 months prior to randomization - New York Heart Association (NYHA) III or IV heart failure, or known left ventricular ejection fraction < 30% - Uncontrolled cardiac arrhythmia - Myocardial infarction, unstable angina, percutaneous coronary intervention (PCI), coronary artery bypass graft (CABG) or stroke within 3 months prior to randomization - Type 1 diabetes; newly diagnosed or poorly controlled type 2 diabetes (HbA1c > 8.5%) - Uncontrolled hypertension