Reduction of LDL-C With PCSK9 Inhibition in Heterozygous Familial Hypercholesterolemia Disorder Study (RUTHERFORD)
This study has been completed.
Sponsor:
Amgen
Information provided by (Responsible Party):
Amgen
ClinicalTrials.gov Identifier:
NCT01375751
First received: June 16, 2011
Last updated: April 2, 2013
Last verified: April 2013
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Purpose
The primary hypothesis is that a dose of AMG 145 every-4-weeks (Q4W) subcutaneous (SC) will be well tolerated and will result in greater lowering of Low-Density Lipoprotein Cholesterol (LDL-C) at week 12 than placebo in subjects with heterozygous familial hypercholesterolemia
| Condition | Intervention | Phase |
|---|---|---|
|
Hypercholesterolemia, Familial |
Drug: AMG 145 Drug: PLACEBO |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | A Double-blind, Randomized, Placebo-controlled, Multicenter Study to Evaluate Tolerability and Efficacy of AMG 145 on Low-Density Lipoprotein Cholesterol (LDL-C) in Subject With Heterozygous Familial Hypercholesterolemia |
Resource links provided by NLM:
Genetics Home Reference related topics:
Chanarin-Dorfman syndrome
cholesteryl ester storage disease
Farber lipogranulomatosis
hypercholesterolemia
MedlinePlus related topics:
Cholesterol
U.S. FDA Resources
Further study details as provided by Amgen:
Primary Outcome Measures:
- The percent change from baseline in Low-Density Lipoprotein Cholesterol (LDL-C) at week 12 [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Absolute change from baseline in Low-Density Lipoprotein Cholesterol (LDL-C) at week 12 [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
- Percent change from baseline in non-High Density Lipoprotein Cholesterol (HDL-C) at week 12 [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
- Percent change from baseline in Apolipoprotein B (ApoB) at week 12 [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
- Percent change from baseline in the total cholesterol/High Density Lipoprotein Cholesterol (HDL-C) at week 12 [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
- Percent change from baseline in Apolipoprotein B (ApoB)/Apolipoprotein A-1 (ApoA1) ratio at week 12 [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
| Enrollment: | 168 |
| Study Start Date: | July 2011 |
| Study Completion Date: | July 2012 |
| Primary Completion Date: | May 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Group 1
AMG 145
|
Drug: AMG 145
Dose 1 every 4 weeks
|
|
Experimental: Group 2
AMG 145
|
Drug: AMG 145
Dose 2 every 4 weeks
|
|
Placebo Comparator: PLACEBO
PLACEBO
|
Drug: PLACEBO
Every 4 weeks
|
Eligibility| Ages Eligible for Study: | 18 Years to 75 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations More Information
Additional Information:
No publications provided by Amgen
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Amgen |
| ClinicalTrials.gov Identifier: | NCT01375751 History of Changes |
| Other Study ID Numbers: | 20090158 |
| Study First Received: | June 16, 2011 |
| Last Updated: | April 2, 2013 |
| Health Authority: | Hong Kong: Department of Health Netherlands:Centrale Commissie Mensgebonden Onderzoek (CCMO) Norway: Norwegian Medicines Agency Singapore: Health Science Authority South Africa: Medicines Control Council Spain: Agencia Española de Medicamentos y Productos Sanitarios Sweden: Medical Products Agency United Kingdom: Medicines and Healthcare Products Regulatory Agency United States: Food and Drug Administration Canada: Health Canada Germany: Paul_Ehrlich-Institut Bundesamt fur Sera und Impfstoffe |
Keywords provided by Amgen:
|
Heterozygous Familial Hypercholesterolemia |
Additional relevant MeSH terms:
|
Hypercholesterolemia Hyperlipoproteinemia Type II Hyperlipidemias Dyslipidemias Lipid Metabolism Disorders |
Metabolic Diseases Lipid Metabolism, Inborn Errors Metabolism, Inborn Errors Genetic Diseases, Inborn Hyperlipoproteinemias |
ClinicalTrials.gov processed this record on May 22, 2013