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 @ 4:38 PM
Ignite Modification Date:
2025-12-24 @ 4:38 PM
NCT ID:
NCT01763866
Eligibility Criteria:
Inclusion Criteria:
* Male or female ≥ 18 to ≤ 80 years of age
* Subjects not taking a statin must have fasting LDL-C of at least 150 mg/dL (4.0 mmol/L)
* Subjects already on a non-intensive statin must have fasting LDL-C at screening ≥ 100 mg/dL (2.6 mmol/L)
* Subjects already on a intensive statin must have fasting LDL-C at screening ≥ 80 mg/dL (2.1 mmol/L)
* Fasting triglycerides ≤ 400 mg/dL (4.5 mmol/L)
Exclusion Criteria:
* Statin intolerance
* New York Heart association (NYHA) III or IV heart failure
* Uncontrolled hypertension
* Uncontrolled cardiac arrhythmia
* Type 1 diabetes, poorly controlled type 2 diabetes
* Uncontrolled hypothyroidism or hyperthyroidism
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT01763866
Study Brief:
Protocol Section:
NCT01763866