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
Clearwater, Florida 33756
830
mi
from 43215
Clearwater, FL
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Alexandria, Louisiana 71301
797
mi
from 43215
Alexandria, LA
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Amarillo, Texas 79106
1078
mi
from 43215
Amarillo, TX
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Atlanta, Georgia 30322
432
mi
from 43215
Atlanta, GA
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Auburn, Maine 04210
714
mi
from 43215
Auburn, ME
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Baltimore, Maryland 21215
344
mi
from 43215
Baltimore, MD
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Bangor, Maine 04401
798
mi
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Bangor, ME
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Birmingham, Alabama 35211
491
mi
from 43215
Birmingham, AL
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Boise, Idaho 83712
1711
mi
from 43215
Boise, ID
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Bridgeport, Connecticut 06606
521
mi
from 43215
Bridgeport, CT
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Brooklyn, New York 11215
280
mi
from 43215
Brooklyn, NY
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Buffalo, New York 14215
294
mi
from 43215
Buffalo, NY
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Cincinnati, Ohio 45219
94
mi
from 43215
Cincinnati, OH
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Concord, California 94520
2083
mi
from 43215
Concord, CA
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Concord, California 94520
2083
mi
from 43215
Concord, CA
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Dallas, Texas 75216
911
mi
from 43215
Dallas, TX
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Danbury, Connecticut 06810
510
mi
from 43215
Danbury, CT
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Detroit, Michigan 48202
163
mi
from 43215
Detroit, MI
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Durham, North Carolina 27705
354
mi
from 43215
Durham, NC
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Elizabeth City, North Carolina 27909
333
mi
from 43215
Elizabeth City, NC
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Elkhart, Indiana 46514
194
mi
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Elkhart, IN
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Evanston, Illinois 60201
282
mi
from 43215
Evanston, IL
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Greeneville, Tennessee 37745
262
mi
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Greeneville, TN
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Greenwood, South Carolina 29646
401
mi
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Greenwood, SC
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Hershey, Pennsylvania 17033
337
mi
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Hershey, PA
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Herston, Queensland 4006
9156
mi
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Herston,
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High Point, North Carolina 27262
303
mi
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High Point, NC
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Huntsville, Alabama 35801
409
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Huntsville, AL
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Indianapolis, Indiana 46290
166
mi
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Indianapolis, IN
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16003 Florida Avenue
Jacksonville, Florida 32209
677
mi
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Jacksonville, FL
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Lancaster, Pennsylvania 17604
355
mi
from 43215
Lancaster, PA
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Lexington, Kentucky 40536
157
mi
from 43215
Lexington, KY
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Lexington, Kentucky 40536
157
mi
from 43215
Lexington, KY
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Littleton, Colorado 80120
1164
mi
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Littleton, CO
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Louisville, Kentucky 40202
188
mi
from 43215
Louisville, KY
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Minneapolis, Minnesota 55407
625
mi
from 43215
Minneapolis, MN
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New York, New York 10029
481
mi
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New York, NY
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Petoskey, Michigan 49770
386
mi
from 43215
Petoskey, MI
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Philadelphia, Pennsylvania 19104
416
mi
from 43215
Philadelphia, PA
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Rapid City, South Dakota 57701
1072
mi
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Rapid City, SD
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Richmond, Virginia 23298
342
mi
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Richmond, VA
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Sacramento, California 95819
2041
mi
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Sacramento, CA
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St. Paul, Minnesota 55102
617
mi
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St. Paul, MN
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Torrance, California 90502
1980
mi
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Torrance, CA
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Tupelo, Mississippi 38801
503
mi
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Tupelo, MS
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Wausau, Wisconsin 54401
481
mi
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Wausau, WI
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West Des Moines, Iowa 50266
571
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West Des Moines, IA
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Wichita Falls, Texas 76301
949
mi
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Wichita Falls, TX
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Winston-Salem, North Carolina 27157
306
mi
from 43215
Winston-Salem, NC
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