Status:
COMPLETED
A Single Ascending Dose Study Examining the Safety and Pharmacokinetic Profile of Reconstituted High Density Lipoprotein (CSL112) Administered to Patients
Lead Sponsor:
CSL Limited
Conditions:
Stable Atherothrombotic Disease
Eligibility:
All Genders
18-80 years
Phase:
PHASE2
Brief Summary
Reconstituted high density lipoprotein used in patients with acute coronary syndrome (ACS) may reduce atherosclerotic plaque burden, thereby reducing the risk of recurrent cardiovascular events. This ...
Eligibility Criteria
Inclusion
- Male or female aged 18 years to 80 years.
- Subjects must have documented evidence of a history of atherosclerotic coronary artery disease/surgical revascularization.
- Subjects on a stable medication regimen.
- Body weight 50 kg or greater at screening.
Exclusion
- Moderate/severe heart failure or renal impairment.
- Uncontrolled hyperglycemia in subjects with type 1 or type 2 diabetes.
- Receipt of the combination of omeprazole and clopidogrel within 1 month of randomization.
- Subjects whose medical history, condition or medication regimen may interfere with the evaluation of the safety and tolerability of CSL112 (for example significantly altered electrocardiogram (ECG) waveform, hepatobiliary disease, malignancy, thrombocytopenia, etc.)
- Known hypersensitivity to the product components
Key Trial Info
Start Date :
February 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2013
Estimated Enrollment :
45 Patients enrolled
Trial Details
Trial ID
NCT01499420
Start Date
February 1 2012
End Date
March 1 2013
Last Update
February 6 2014
Active Locations (11)
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1
Study Site
Chula Vista, California, United States, 91911
2
Study Site
Jacksonville, Florida, United States, 32209
3
Study Site
Miami, Florida, United States, 33126
4
Study Site
Lexington, Kentucky, United States, 40536