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 @ 4:04 PM
Ignite Modification Date:
2025-12-24 @ 4:04 PM
NCT ID:
NCT01414166
Eligibility Criteria:
Inclusion criteria:
* LMT ineligible
* Participants must meet the lipid criteria of "low to moderate CHD risk" as defined by National Cholesterol Education Program Adult Treatment Panel III Framingham Point Scores (NCEP ATP III)
* HDL-C \<40 mg/dL (1.03 mmol/L) in males and \<50 mg/dL (1.29 mmol/L) in females
* Triglyceride (TG) level \<300 mg/dL (3.39 mmol/L).
* Fasting serum glucose (FSG) at Visit 1 AND Visit 2 \<126 mg/dL (\<7 mmol/L)
* Hemoglobin A1c (HbA1c) level \<6.5%
* Participant willing to use acceptable method of contraception during the study, including the 14-day follow-up period
Exclusion criteria:
* History of malignancy ≤5 years prior to signing informed consent, except for adequately-treated basal cell or squamous cell skin cancer or in situ cervical cancer
* Participation in a study with an investigational compound (non-lipid-modifying) within 30 days
* Pregnant, breastfeeding, or expecting to conceive, or father a child during the study, including the 14-day follow-up period
* Consumption of more than 3 alcoholic drinks on any given day or more than 14 drinks per week
* Engages in or plans to engage in vigorous exercise or an aggressive diet regimen during the study
* Diabetes mellitus, based on medical history, FSG ≥126 mg/dL (7 mmol/L), and HbA1c ≥6.5%
* Risk factors for coronary heart disease
* Active or chronic hepatobiliary or hepatic disease
* Active peptic ulcer disease within 3 months of Visit 1
* History of hypersensitivity or allergic reaction to niacin or niacin-containing products
* Episode of gout within 1 year of Visit 1, unless currently stable on allopurinol
* Taking an LMT (including statins, bile acid sequestrants, fibrates and niacin \>50 mg as monotherapy or coadministered with other LMTs)
* Use of over-the- counter or traditional medicine (e.g. red yeast rice products) for lipid-lowering
* Receiving treatment with systemic corticosteroids (unless on stable therapy for at lest 6 weeks for replacement for pituitary/adrenal/hypogonadal disease)
* Uncontrolled illness or infection
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01414166
Study Brief:
Protocol Section:
NCT01414166