A Phase 2b Study of CSL112 in Subjects With Acute Myocardial Infarction.



Status:Completed
Conditions:Cardiology
Therapuetic Areas:Cardiology / Vascular Diseases
Healthy:No
Age Range:18 - Any
Updated:12/15/2016
Start Date:August 2014
End Date:March 2016

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A Phase 2b, Multi-center, Randomized, Placebo-controlled, Dose-ranging Study to Investigate the Safety and Tolerability of Multiple Dose Administration of CSL112 in Subjects With Acute Myocardial Infarction.

This is a multicenter randomized, double-blind, placebo-controlled, parallel-group,
dose-ranging phase 2b study to investigate the hepatic and renal safety and tolerability of
multiple dose administration of two dose levels of CSL112 compared with placebo in subjects
with acute myocardial infarction (AMI).


Inclusion Criteria:

- Men or women, at least 18 years of age, with evidence of myocardial necrosis in a
clinical setting consistent with a type I (spontaneous) acute myocardial infarction
(AMI), in the last week.

Exclusion Criteria:

- Ongoing hemodynamic instability

- Evidence of hepatobiliary disease

- Evidence of chronic kidney disease (CKD) (Stage III, IV, or V), defined as moderate
or severe renal impairment or if subject is receiving dialysis

- Evidence of unstable renal function

- History of acute kidney injury after previous exposure to an intravenous contrast
agent.

- Known history of allergies, hypersensitivity or deficiencies to CSL112 or any of its
components

- Other severe comorbid condition, concurrent medication, or other issue that renders
the subject unsuitable for participation in the study
We found this trial at
49
sites
Dallas, Texas 75216
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Alexandria, Louisiana 71301
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Amarillo, Texas 79106
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Atlanta, Georgia 30322
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Auburn, Maine 04210
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Baltimore, Maryland 21215
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Bangor, Maine 04401
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Birmingham, Alabama 35211
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Boise, Idaho 83712
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Bridgeport, Connecticut 06606
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Brooklyn, New York 11215
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Buffalo, New York 14215
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Cincinnati, Ohio 45219
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Clearwater, Florida 33756
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Concord, California 94520
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Concord, CA
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Concord, California 94520
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Danbury, Connecticut 06810
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Detroit, Michigan 48202
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Durham, North Carolina 27705
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Elizabeth City, North Carolina 27909
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Elkhart, Indiana 46514
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Evanston, Illinois 60201
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Greeneville, Tennessee 37745
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Greenwood, South Carolina 29646
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Hershey, Pennsylvania 17033
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Herston, Queensland 4006
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High Point, North Carolina 27262
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Huntsville, Alabama 35801
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Indianapolis, Indiana 46290
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16003 Florida Avenue
Jacksonville, Florida 32209
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Lancaster, Pennsylvania 17604
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Lexington, Kentucky 40536
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Lexington, Kentucky 40536
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Littleton, Colorado 80120
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Louisville, Kentucky 40202
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Minneapolis, Minnesota 55407
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New York, New York 10029
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Petoskey, Michigan 49770
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Philadelphia, Pennsylvania 19104
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Rapid City, South Dakota 57701
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Richmond, Virginia 23298
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Sacramento, California 95819
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St. Paul, Minnesota 55102
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Torrance, California 90502
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Tupelo, Mississippi 38801
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Wausau, Wisconsin 54401
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West Des Moines, Iowa 50266
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Wichita Falls, Texas 76301
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Winston-Salem, North Carolina 27157
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