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Study Complete
Sponsor ID
20110271

Trial Assessing long term USe of PCSK9 Inhibition in Subjects with Genetic LDL DisordersTAUSSIG

Sponsor ID
20110271
Clinicaltrials.gov ID
NCT01624142
EUCTIS ID
N/A
EudraCT ID
2011-005400-15
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Study Details

A study to assess the long term safety and tolerability of evolocumab (AMG 145) in adolescents and adults with severe familial hypercholesterolemia.

Additional Study Details

Phase
Phase 2/Phase 3
Product
Evolocumab
Type
Interventional
Masking
None (Open Label)
Enrollment
300
Additional Study Details

Protocol Summary

Primary Outcome Measures

Subject incidence of treatment emergent adverse events

Timeframe: 5 years

Secondary Outcome Measures

Percent change in low density lipoprotein-cholesterol

Timeframe: Every scheduled visit over 5 years

Percent change in non-high density lipoprotein-cholesterol

Timeframe: Every scheduled visit over 5 years

Percent change in apolipoprotein B

Timeframe: Every scheduled visit over 5 years

Percent change in total cholesterol/high density lipoprotein-cholesterol ratio

Timeframe: Every scheduled visit over 5 years

Percent change in apolipoprotein B/apolipoprotein A1 ratio

Timeframe: Every scheduled visit over 5 years

Percent change in lipoprotein(a)

Timeframe: Every scheduled visit over 5 years

Response rate of subjects with 15% or greater reduction in low density lipoprotein-cholesterol

Timeframe: Every scheduled visit over 5 years

Study Documents

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

Locations

Location
Status
Contact Us
Location
Research Site
Cincinnati, OH, United States, 45227
Status
Recruiting
Location
Research Site
Bruxelles, Belgium, 1200
Status
Recruiting
Location
Research Site
Johannesburg, Gauteng, South Africa, 2193
Status
Recruiting
Location
Research Site
Athens, Greece, 17674
Status
Recruiting
Location
Research Site
Suita, Osaka, Japan, 565-8565
Status
Recruiting
Location
Research Site
Kanazawa, Ishikawa, Japan, 920-8641
Status
Recruiting
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Study Info
Age
12 - 80 Years
Condition
  • Cholesterol
    • Sex
    All
    Trial Dates
    Jun 2012 - May 2018
    Inclusion and Exclusion Criteria
    Inclusion Criteria:
    - Participated in Study 20110233 (NCT01588496) or another qualifying evolocumab parent protocol and have a diagnosis of familial hypercholesterolemia. 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 coronary heart disease (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) - Body weight 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