Overview

This trial is active, not recruiting.

Condition severe familial hypercholesterolemia
Treatments evolocumab (amg145)
Phase phase 2/phase 3
Sponsor Amgen
Start date June 2012
End date March 2020
Trial size 300 participants
Trial identifier NCT01624142, 20110271

Summary

A study to assess the long term safety and efficacy of Evolocumab (AMG145)on Low Density Lipoprotein-Cholesterol (LDL-C) in subjects with severe familial hypercholesterolemia.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
Dose 1 of subcutaneous Evolocumab (AMG145)every month
evolocumab (amg145)
every month
(Experimental)
Dose 2 of subcutaneous Evolocumab (AMG145)every 2 weeks
evolocumab (amg145)
every 2 weeks

Primary Outcomes

Measure
Subject incidence of treatment emergent adverse events
time frame: 5 years

Secondary Outcomes

Measure
Percent change in low density lipoprotein-cholesterol
time frame: Every scheduled visit over 5 years
Percent change in non-high density lipoprotein-cholesterol
time frame: Every scheduled visit over 5 years
Percent change in apolipoprotein B
time frame: Every scheduled visit over 5 years
Percent change in total cholesterol/high density lipoprotein-cholesterol ratio
time frame: Every scheduled visit over 5 years
Percent change in apolipoprotein B/apolipoprotein A1 ratio
time frame: Every scheduled visit over 5 years
Percent change in lipoprotein(a)
time frame: Every scheduled visit over 5 years
Response rate of subjects with 15% or greater reduction in low density lipoprotein-cholesterol
time frame: Every scheduled visit over 5 years

Eligibility Criteria

Male or female participants from 12 years up to 80 years old.

Inclusion Criteria: - Participated in a qualifying Evolocumab (AMG145) parent protocol OR - Have a diagnosis of familial hypercholesterolemia AND - Males and females ≥ 12 to ≤ 80 years of age - Stable low-fat diet and lipid-lowering therapies for at least 4 weeks - Low Density Lipoprotein - Cholesterol (LDL-C) >=130 mg/dl (3.4 mmol/L) for subjects without diagnosed CHD/CHD risk equivalent OR LDL-C >= 100 mg/dl (2.6 mmol/L) for subjects with diagnosed CHD or CHD risk equivalent OR apheresis patients have no LDL-C entry requirement - Fasting triglycerides < 400 mg/dL(4.5 mmol/L) - Bodyweight of > 40 kg or greater at screening for subjects less than 18 years of age Exclusion Criteria: - New York Heart Failure Association (NYHA) class III or IV or last known left ventricular ejection fraction < 30% - Myocardial infarction, unstable angina, percutaneous coronary intervention (PCI), coronary artery bypass graft (CABG) or stroke within 3 months of screening - Planned cardiac surgery or revascularization - Uncontrolled cardiac arrhythmia - Uncontrolled hypertension

Additional Information

Official title A Multicenter, Open-label Study to Assess the Long-term Safety, Tolerability, and Efficacy of Evolocumab (AMG145) on LDL-C in Subjects With Severe Familial Hypercholesterolemia
Trial information was received from ClinicalTrials.gov and was last updated in June 2015.
Information provided to ClinicalTrials.gov by Amgen.