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 @ 3:06 PM
Ignite Modification Date:
2025-12-24 @ 3:06 PM
NCT ID:
NCT00079859
Eligibility Criteria:
Inclusion Criteria:
In order to participate in this study, patients must meet all of the following inclusion criteria:
* be between 18 and 70 years old with a diagnosis of HeFH;
* be stable on and maintain concomitant therapy with hypolipidemic drugs or treatments;
* have an appropriate calculated, fasting LDL-C levels and an appropriate triglyceride (TG) level;
* be male or nonpregnant, nonlactating female;
* give informed consent; and
* meet body weight requirements.
Exclusion Criteria:
In order to participate in this study, patients must not meet any of the following exclusion criteria:
* recent myocardial infarction, percutaneous transluminal coronary intervention, coronary artery bypass graft surgery, or cerebrovascular accident;
* uncontrolled hypothyroidism or other uncontrolled endocrine disease;
* known, clinically significant eye abnormalities (e.g., cataracts);
* appropriate serum creatinine phosphokinase levels;
* history of liver disease or liver enzyme levels above appropriate levels;
* alkaline phosphatase above appropriate levels;
* serum creatinine above appropriate levels;
* liver cirrhosis and severe liver steatosis;
* clinically significant infection, malignancy, or psychosis;
* use of oral anticoagulants or digoxin, unless the dose has been stable for 4 weeks;
* participation in any other investigational study, including device or observational studies, within 30 days;
* lactating or have a positive serum pregnancy test;
* current drug or alcohol abuse; or
* unwillingness to comply with study procedures, including follow-up, as specified by this protocol, or unwillingness to cooperate fully with the investigator
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
70 Years
Study:
NCT00079859
Study Brief:
Protocol Section:
NCT00079859