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 |
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).
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
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