Status:
COMPLETED
Effects on Lipoprotein Metabolism From PCSK9 Inhibition Utilizing a Monoclonal Antibody
Lead Sponsor:
Amgen
Conditions:
Primary Hyperlipidemia and Mixed Dyslipidemia
Eligibility:
MALE
18-65 years
Phase:
PHASE3
Brief Summary
This is a randomized, double-blind, placebo-controlled trial to evaluate the effect of evolocumab, atorvastatin, and combination therapy on lipoprotein kinetics.
Eligibility Criteria
Inclusion
- Fasting LDL-C at screening ≥ 100 mg/dL and ≤ 190 mg/dL
- Fasting triglycerides ≤ 150 mg/dL
- Body mass index (BMI) between 18.0 and 32.0 kg/m\^2
- Framingham cardiac risk score 10% or less
Exclusion
- Treatment with a lipid-regulating drug or over the counter supplement in the last 3 months prior to screening
- History of coronary heart disease (CHD) or CHD equivalent
- Uncontrolled hypertension
- Diabetes mellitus
Key Trial Info
Start Date :
July 8 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 5 2015
Estimated Enrollment :
89 Patients enrolled
Trial Details
Trial ID
NCT02189837
Start Date
July 8 2014
End Date
March 5 2015
Last Update
October 3 2018
Active Locations (2)
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1
Research Site
Adelaide, South Australia, Australia, 5000
2
Research Site
Nedlands, Western Australia, Australia, 6009