A Pilot Study to Measure Plasma and Urinary Prostaglandin D2 Metabolites Evoked by Niacin

NCT01275300 NA COMPLETED Results posted

The investigator would like to see if aspirin could block niacin-induced flushing by analyzing blood and urine after taking aspirin. Phase I: Subjects were assigned to either placebo or aspirin groups. They were given 5 days of 81 mg aspirin or placebo. On day 5, they were given a single dose of niacin (600 mg) administered 30 minutes after the last dose of aspirin or placebo. The same subjects came back for cross-over study and were assigned to a different group. There was a 2-week washout period between each treatment. Urine was collected sequentially for analysis Phase II: The same study subjects come back for an open label one week study. They were given 5 days of taking 81 mg Aspirin, taken once daily, followed by a single dose of 600 mg Niacin on day 6. Urine was collected sequentially for analysis

Details

Lead sponsor	University of Pennsylvania
Phase	NA
Status	COMPLETED
Enrolment	9
Start date	2007-07
Completion	2012-01

Conditions

• Hyperlipidemia

Interventions

• Aspirin
• Placebo
• Niacin

Primary outcomes

• Percentage Change of Area Under Curve for the Urinary Prostaglandins Concentration Versus Time Curve (AUC) in Response to Aspirin or Placebo — -2-0, 0-2, 2-4, 4-6, 6-12 and 12-24 hours pre or post niacin
  Percentage change of area under the urinary prostaglandins concentration versus time curve (AUC) in response to niacin with or without pretreatment of aspirin was studied. This outcome measures whether aspirin instead of placebo will impact the subjects' response to niacin. The area was normalized by percentile.

Countries

United States