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:
2025-12-24 @ 7:46 PM
Ignite Modification Date:
2025-12-24 @ 7:46 PM
NCT ID:
NCT00799903
Eligibility Criteria:
Inclusion Criteria:
* Men or women at least 18 years old. Women must be post-menopausal or using a highly effective method for avoidance of pregnancy.
* Current treatment with statin therapy unless the study doctor determines statins are not appropriate for the subject.
* Chronic coronary heart disease
* At least one of the following:
* At least 60 years old
* Diabetes requiring treatment with medication
* Low HDL cholesterol ("good cholesterol")
* Currently smoke cigarettes or stopped smoking within the past 3 months
* Diagnosed mild or moderate reduction in kidney function
* Cerebrovascular disease (carotid artery disease or ischemic stroke more than 3 months prior to study entry) OR peripheral arterial disease.
Exclusion Criteria:
* Planned coronary revascularization (such as stent placement or heart bypass) or any other major surgical procedure.
* Liver disease
* Severe reduction in kidney function OR removal of a kidney OR kidney transplant
* Severe heart failure
* Blood pressure higher than normal despite lifestyle changes and treatment with medications
* Any life-threatening disease expected to result in death within the next 2 years (other than heart disease)
* Severe asthma that is poorly controlled with medication
* Pregnant (Note: A pregnancy test will be performed on all non-sterile women prior to study entry)
* Previous severe allergic response to food, drink, insect stings, etc.
* Drug or alcohol abuse within the past 6 months OR mental/psychological impairment that may prevent the subject from complying with study procedures or understanding the goal and potential risks of participating in the study.
* Certain medications that may interfere with the study medication (these will be identified by the study doctor)
* Participation in a study of an investigational medication within the past 30 days
* Current participation in a study of an investigational device
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00799903
Study Brief:
Protocol Section:
NCT00799903