Status:
COMPLETED
Alternative Options to Minimize Niacin-Induced Flushing
Lead Sponsor:
Patrick Moriarty, MD, FACP, FACC
Conditions:
Hypercholesterolemia
Flushing
Eligibility:
All Genders
21-70 years
Phase:
NA
Brief Summary
Niacin (Vitamin B3) is known to effectively and safely treat hypercholesterolemia. However, use of niacin is limited due to incidents of flushing which limits its acceptability. Some information sugge...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
January 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2010
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT00895193
Start Date
January 1 2009
End Date
December 1 2010
Last Update
June 5 2014
Active Locations (1)
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1
University of Kansas Medical Center
Kansas City, Kansas, United States, 66160