Status:
COMPLETED
Advancing Niacin by Inhibiting Flushing (ANTI-FLUSH)
Lead Sponsor:
University of Pennsylvania
Collaborating Sponsors:
Abbott
Conditions:
Flushing
Eligibility:
All Genders
21-75 years
Phase:
PHASE4
Brief Summary
Niacin, or vitamin B3, is known to improve cholesterol disorders and is the most effective drug to raise HDL, or the "good cholesterol". The use of niacin has been limited because of a peculiar advers...
Detailed Description
This study involves people between 21 and 75 years. It will be conducted over a period of 8 weeks, with 4 visits, each separated by 2 weeks. The duration of each visit is 9-10 hours. We will test a di...
Eligibility Criteria
Inclusion
- Men and women from the age of 21 to 75, inclusive - 16 subjects, 8 men, 8 women.
- Ability to understand and agree to informed consent.
- Are reliable and willing to make themselves available for the duration of the study and are willing to follow study procedures.
Exclusion
- Contra-indications or known intolerance to the study medications.
- History of congestive heart failure, carcinoid, rosacea, renal failure (GFR\<60 ml/min/m2).
- Active liver disease.
- Active diabetes (defined as any history of type 1 diabetes, or history of type 2 diabetes plus one or more of the following: fasting glucose\>= 126mg/dL at screening or use of anti-diabetic medications within 12 months, or glucose\>200mg/dL 2 hours after a 75 g oral glucose challenge within 12 months.
- History of major surgery within the past 6 weeks, or anticipated major surgery during the course of the study, or any history of organ transplant.
- History of drug abuse within the past 3 years, or regular alcohol use of greater than 14 drinks per week.
- Women who are pregnant, plan to conceive or lactate.
- Peri-menopausal women or women currently experiencing flushing.
- Currently taking vasoactive medications, anti-hypertensives, anti-histamines, Selective Serotonin Re-uptake Inhibitors (SSRIs), NSAIDS, oral steroids, leukotriene inhibitors, supplemental quercetin and \> 50mg niacin.
Key Trial Info
Start Date :
February 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2009
Estimated Enrollment :
17 Patients enrolled
Trial Details
Trial ID
NCT00913081
Start Date
February 1 2009
End Date
December 1 2009
Last Update
March 5 2015
Active Locations (2)
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1
CTRC Univ. of Penn - Andrew Mutch Bldg., 4th floor
Philadelphia, Pennsylvania, United States, 19104
2
University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104