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:
2025-12-25 @ 1:14 AM
Ignite Modification Date:
2025-12-25 @ 1:14 AM
NCT ID:
NCT00895193
Eligibility Criteria:
Inclusion Criteria:
* An adult between 21 and 70 years of age.
* Male or female (If female must be postmenopausal for at least 1 year, surgically sterile or using an effective form of contraception).
* Able to speak and read English.
* Willing to comply with study specific instructions, and complete all study procedures according to protocol.
* Able to understand study rationale and sign informed consent.
Exclusion Criteria:
* Females of child-bearing potential not using acceptable method of contraception and perimenopausal females.
* History of gout
* History of diabetes mellitus
* History of coronary heart disease
* History of, or currently experiencing, renal disease including, but not limited to, renal insufficiency, nephrolithiasis or chronic renal failure.
* History of, or currently experiencing, major chronic gastrointestinal condition including gallbladder disease, liver disease and peptic ulcer disease
* Known sensitivity to niacin, Aspirin or nonsteroidal anti-inflammatory agents (NSAIDs)
* History of migraine or cluster headaches
* Currently using antihistamines, aspirin or NSAIDS on a consistent basis
* Presence or history of any medical or psychosocial condition that, in the opinion of the investigator, would limit the patient's successful participation or would compromise the patient's safe participation.
* Lab abnormalities at screening, including but not limited to elevated liver enzymes or blood sugar levels that might indicate additional risk to the patient's continued participation.
* Currently taking medication that might be contraindicated with the study drug or Niacin or study procedures (including Niacin, lipid-lowering drugs, chronic aspirin or laxative use).
* Clinically significant finding from physical exam that would affect the patient's safe participation or completion of the study.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
21 Years
Maximum Age:
70 Years
Study:
NCT00895193
Study Brief:
Protocol Section:
NCT00895193