Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 4:29 AM
Ignite Modification Date:
2025-12-25 @ 4:29 AM
NCT ID:
NCT01499420
Eligibility Criteria:
Inclusion Criteria:
* 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 Criteria:
* 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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT01499420
Study Brief:
Protocol Section:
NCT01499420