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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

2014-08-27 03:13:20 | BioPortfolio

Summary

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Conditions

Hyperlipidemia

Intervention

AMG 145, Placebo

Location

Research Site
Chicago
Illinois
United States

Status

Recruiting

Source

Amgen

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:13:20-0400

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