Ascending Multiple Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of AMG 145 in Subjects With Hyperlipidemia on Stable Doses of a Statin



Status:Archived
Conditions:High Cholesterol
Therapuetic Areas:Cardiology / Vascular Diseases
Healthy:No
Age Range:Any
Updated:7/1/2011
Start Date:June 2010
End Date:March 2012

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A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Ascending Multiple Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of AMG 145 in Subjects With Hyperlipidemia on Stable Doses of a Statin


AMG 145 is being developed for the treatment of hypercholesterolemia. The purpose of the
study is to evaluate the safety and tolerability of multiple doses of AMG 145 when given as
an add-on to stable statin therapy. The study hypotheses are that no significant safety
issues will be identified following multiple SC doses of AMG 145 when administered as an
add-on to stable statin therapy, and there will be a statistically significant decrease in
LDL-C (low density lipoprotein cholesterol) levels following multiple SC doses of AMG 145
when administered as an add-on to stable statin therapy compared to placebo.



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