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
Greenwood, South Carolina 29646
822
mi
from 02139
Greenwood, SC
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Alexandria, Louisiana 71301
1399
mi
from 02139
Alexandria, LA
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Amarillo, Texas 79106
1716
mi
from 02139
Amarillo, TX
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Atlanta, Georgia 30322
929
mi
from 02139
Atlanta, GA
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Auburn, Maine 04210
127
mi
from 02139
Auburn, ME
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Baltimore, Maryland 21215
357
mi
from 02139
Baltimore, MD
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Bangor, Maine 04401
204
mi
from 02139
Bangor, ME
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Birmingham, Alabama 35211
1048
mi
from 02139
Birmingham, AL
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Boise, Idaho 83712
2248
mi
from 02139
Boise, ID
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Bridgeport, Connecticut 06606
134
mi
from 02139
Bridgeport, CT
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Brooklyn, New York 11215
389
mi
from 02139
Brooklyn, NY
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Buffalo, New York 14215
396
mi
from 02139
Buffalo, NY
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Cincinnati, Ohio 45219
732
mi
from 02139
Cincinnati, OH
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Clearwater, Florida 33756
1192
mi
from 02139
Clearwater, FL
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Concord, California 94520
2665
mi
from 02139
Concord, CA
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Concord, California 94520
2665
mi
from 02139
Concord, CA
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Dallas, Texas 75216
1547
mi
from 02139
Dallas, TX
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Danbury, Connecticut 06810
138
mi
from 02139
Danbury, CT
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Detroit, Michigan 48202
609
mi
from 02139
Detroit, MI
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Durham, North Carolina 27705
606
mi
from 02139
Durham, NC
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Elizabeth City, North Carolina 27909
741
mi
from 02139
Elizabeth City, NC
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Elkhart, Indiana 46514
763
mi
from 02139
Elkhart, IN
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Evanston, Illinois 60201
847
mi
from 02139
Evanston, IL
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Greeneville, Tennessee 37745
758
mi
from 02139
Greeneville, TN
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Hershey, Pennsylvania 17033
321
mi
from 02139
Hershey, PA
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Herston, Queensland 4006
9767
mi
from 02139
Herston,
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High Point, North Carolina 27262
775
mi
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High Point, NC
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Huntsville, Alabama 35801
984
mi
from 02139
Huntsville, AL
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Indianapolis, Indiana 46290
803
mi
from 02139
Indianapolis, IN
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16003 Florida Avenue
Jacksonville, Florida 32209
1035
mi
from 02139
Jacksonville, FL
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Lancaster, Pennsylvania 17604
314
mi
from 02139
Lancaster, PA
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Lexington, Kentucky 40536
766
mi
from 02139
Lexington, KY
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Lexington, Kentucky 40536
766
mi
from 02139
Lexington, KY
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Littleton, Colorado 80120
1766
mi
from 02139
Littleton, CO
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Louisville, Kentucky 40202
821
mi
from 02139
Louisville, KY
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Minneapolis, Minnesota 55407
1118
mi
from 02139
Minneapolis, MN
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New York, New York 10029
182
mi
from 02139
New York, NY
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Petoskey, Michigan 49770
719
mi
from 02139
Petoskey, MI
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Philadelphia, Pennsylvania 19104
269
mi
from 02139
Philadelphia, PA
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Rapid City, South Dakota 57701
1611
mi
from 02139
Rapid City, SD
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Richmond, Virginia 23298
472
mi
from 02139
Richmond, VA
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Sacramento, California 95819
2620
mi
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Sacramento, CA
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St. Paul, Minnesota 55102
1111
mi
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St. Paul, MN
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Torrance, California 90502
2597
mi
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Torrance, CA
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Tupelo, Mississippi 38801
1103
mi
from 02139
Tupelo, MS
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Wausau, Wisconsin 54401
941
mi
from 02139
Wausau, WI
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West Des Moines, Iowa 50266
1160
mi
from 02139
West Des Moines, IA
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Wichita Falls, Texas 76301
1590
mi
from 02139
Wichita Falls, TX
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Winston-Salem, North Carolina 27157
652
mi
from 02139
Winston-Salem, NC
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