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 @ 7:39 PM
Ignite Modification Date:
2025-12-24 @ 7:39 PM
NCT ID:
NCT01308203
Eligibility Criteria:
Inclusion Criteria:
* Men between 21 and 75 years old.
* Very high risk patients (according NCEP-ATP III definition) with coronary heart disease (CHD) or peripheral arterial disease (PAD), documented by an angiographic study.
* Clinical stability.
* Low HDL-C plasma levels: \< 40 mg/dL in men or \<50 mg/dL in women in the screening and lead-in blood sample tests.
* LDL-C plasma levels between 70-100 mg/dL or non-HDL-C between 100-130 mg/dL if TG were \> 200 mg/dL in the screening and lead-in blood sample tests.
* Statin based-treatment with or without ezetimibe in a stable dose in last 8 weeks.
* Women must be postmenopausal for at least 2 years and ≤ 75 years old.
Exclusion Criteria:
* Coronary event o arterial revascularization in the past 6 months.
* Uncontrolled diabetes mellitus (HbA1C \> 8%).
* Acute crisis, history of gout or uric acid \> 9 mg/dL.
* Thyroid stimulating hormone (TSH) outside the central laboratory's normal reference range.
* Renal insufficiency (creatinine \> 1.5 mg/dL).
* Baseline alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST) levels \> 1.5 UNL.
* Baseline creatine kinase (CK) \> 2 UNL.
* Triglycerides plasma level ≥ 500 mg/dL.
* Active fibrate therapy.
* Age \> 75 years old.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
21 Years
Maximum Age:
75 Years
Study:
NCT01308203
Study Brief:
Protocol Section:
NCT01308203