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 @ 9:43 PM
Ignite Modification Date:
2025-12-24 @ 9:43 PM
NCT ID:
NCT00080132
Eligibility Criteria:
Inclusion Criteria:
In order to participate in this study, patients must meet all of the following inclusion criteria:
* be between 8 and 70 years old with diagnosis of Fredrickson Type I or V HTG
* be stable on current maximum tolerated triglyceride lowering therapy
* have a fasting TG level of at least 880 mg/dL (10 mmol/L)
* be male or nonpregnant, nonbreastfeeding female. The women in the study must be surgically sterile, postmenopausal or must practice an effective method of birth control
* must be able to give informed consent or if under the age of 18, parents or legal guardians must give their informed consent
* meet body weight requirements
Exclusion Criteria:
* Recent heart attack, coronary artery intervention, coronary bypass surgery, or stroke.
* Patients with class 3 or 4 heart failure
* Uncontrolled hypothyroidism or other uncontrolled endocrine disease
* Known, clinically significant eye abnormalities, such as cataracts
* History of hepatic disease or AST or ALT levels greater than 1.5 x ULN at Visit 1
* Alkaline phosphatase greater than 2 times ULN
* Serum creatinine greater than 2.0 mg/dL
* Liver cirrhosis and severe liver steatosis
* Clinically significant infection, malignancy, or psychosis
* Use of oral anticoagulants or digoxin unless the dose is stable and is regularly monitored
* Participation in any other investigational study within the last 30 days
* Breastfeeding or pregnant
* Current drug or alcohol abuse
* Serious or unstable medical conditions that would compromise the patient's safety or successful participation in the study
* Unwillingness to comply with study procedures or unwillingness to cooperate fully
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
8 Years
Maximum Age:
70 Years
Study:
NCT00080132
Study Brief:
Protocol Section:
NCT00080132