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 @ 6:56 PM
Ignite Modification Date:
2025-12-24 @ 6:56 PM
NCT ID:
NCT00408057
Eligibility Criteria:
Inclusion Criteria:
1. Patient is male or female older 18 years of age.
2. Patients with a diagnosis of primary hypercholesterolemia and who are defined as being "high risk" (10-year risk of coronary artery disease greater than 20 % based on the Framingham model and history of cardiovascular disease or)
3. Patients who have not reached their recommended LDL-C target levels of 2.5 mmol/L while on a statin alone.
4. According to the judgment of the treating physician patient enrollment is in the best interest of the patient.
5. Patient agrees to participate and signs an informed consent allowing follow up and sharing of patient related data.
Exclusion Criteria:
1. Individuals with poor mental function, drug or substance abuse, or individuals with unstable psychiatric illnesses, which, in the opinion of the investigator, may interfere with optimal participation in the observational study. Alcoholic substance abuse would be defined as a patient with alcohol consumption \> 14 drink per week. (A drink is: a can of beer, glass of wine, or single measure of spirits.)
2. Patients who have been treated with any investigational drug within 30 days prior to Visit 1. (If \<30 days, contact the clinical monitor for a case-by-case evaluation.)
3. Patients with clinically significant concomitant illnesses of liver, muscle or kidney abnormalities.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00408057
Study Brief:
Protocol Section:
NCT00408057