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 @ 6:50 PM
Ignite Modification Date:
2025-12-24 @ 6:50 PM
NCT ID:
NCT00397657
Eligibility Criteria:
Inclusion Criteria:
* Male and female subjects, ≥ 30 years old with either known atherosclerotic coronary or vascular disease OR coronary risk equivalents defined as either:
* diabetes mellitus,
* multiple coronary risk factors with a Framingham Risk Score \> 2% per year, or
* an elevated coronary calcium score (\> 400 for men, \> 200 for women)
* Currently being treated with a statin (Simvastatin 20 mg/d or its equivalent) as monotherapy for treatment of hyperlipidemia
* Recent lipids (within the past 3 months without interval change in the statin regimen) showing both: LDL-C \< 100 mg/dL and HDL-C \< 50 mg/dL (men) or \< 55 mg/dL (women)
Exclusion Criteria:
* Current use of or known intolerance to niacin or ezetimibe
* Known history of liver disease (cirrhosis, chronic hepatitis) or abnormal liver associated enzymes, \> 3x the upper laboratory reference value
* Enrollment in another drug or device research protocol
* Females who are pregnant, expect to get pregnant during the course of the study, or are breastfeeding
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
30 Years
Study:
NCT00397657
Study Brief:
Protocol Section:
NCT00397657